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    Company profile for Biophore India Pharmaceuticals Pvt Ltd

    Biophore Mix GIF-PSE
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    Biophore, its subsidiary Zenara, receive first approval for Cannabidiol in India

    15 May 2023

    // HEALTH ET

    Akums enters into a joint association with Leiutis & Biophore

    01 Dec 2022

    // ECONOMICTIMES

    Zenara Pharma Launches Generic Of Paxlovid For COVID-19 In India

    09 Sep 2022

    // OUTLOOKINDIA

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    #PharmaFlow

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    Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    About

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

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    Biophore India Pharmaceuticals Pvt Ltdindia-flag Flag
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    Plot#92;1-98/2/92, Kavuri Hills –Phase II, Jubilee Hills,Hyderabad 33,Telang...
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    US LIASION OFFICE

    Biophore Pharma Inc.
    1 Deerpark Drive, Suite F-8,
    Monmouth Junction,
    New Jersey 08852, USA
    Contact : +1-(609) 275-3713
    Email:    info@biophore.com

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    INTERVIEW #SpeakPharma

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    “We want to emerge as the most trusted API firm in complex drug molecule segments”

    mic“We want to emerge as the most trusted API firm in complex drug molecule segments”

    This week, Speakpharma interviews Dr. Jagadeesh Babu Rangisetty, CEO of Biophore India Pharmaceuticals. The Hyderabad (India)-based company has four US Food and Drug Administration (FDA) and European Union inspected manufacturing facilities for active pharmaceutical ingredients (APIs) situated in Visakhapatnam, one dedicated intermediate facility and a world-class R&D lab housing 500 scientists with varied expertise. Now, the company hopes to emerge as the most trusted organization in the complex and niche pharmaceutical molecule segments.Can you provide an overview of Biophore’s expertise in developing complex APIs?Since our inception in 2007, Biophore has established itself as a company that focuses extensively on R&D to deliver exceptional value and end-to-end solutions to our clients.In 2010, we filed our first DMF (drug master file) in the US. Since then, we have successfully filed over 120 DMFs in the US and over 25 Certificates of Suitability (issued by the European Directorate for the Quality of Medicines), along with regulatory filings across Canada, China, Korea, Middle East and North Africa (MENA) and other global markets. Over the past five years, we have consistently ranked among the top 5 DMF filers.Our primary focus is to leverage our research strength and deliver products with complex chemistry and high entry barriers to our clients.  Over the years, we have developed such an expertise in niche and complex products and our customers look to us when it comes to critical products.We operate four world-class facilities that allow us to cover a wide range of therapeutic areas. Currently, Biophore serves over 300 customers, including several top 20 pharmaceutical companies.Can you explain the role of Biophore’s state-of-the-art technology development center in development of these products?Our state-of-the-art technology development center, situated in Hyderabad (India), plays a central role in advancing the development of niche pharmaceutical products. It serves as a research and innovation hub, allowing us to generate new ideas, work on them and deliver a robust product fit for the global markets.The center is equipped with specialized laboratories for various therapeutic segments, such as peptides and oncology products and also has sophisticated analytical instruments that facilitates complex API characterizations. Our dedicated research team is working on over 20 development projects at any given time.What are some of the key therapeutic areas that Biophore focuses on?Biophore focuses on several niche and complex therapeutic areas such as oncology, peptides, contrast media, colored APIs, hormonals, iron products, and injectable APIs. We have deep expertise in delivering time bound APIs to the market. We are also recognized as a global leader when it comes to products for orphan indications to provide treatment options for rare diseases.What are some of the challenges being faced by Biophore, and how does the company address them?The generic industry has been facing challenges of late due to various factors. These include intense price pressures, supply chain disruptions and increasing competition.To tackle these obstacles, we have implemented a range of strategies. One, we have adopted a backward integration approach for intermediates that gives us greater control over the supply chain and reduces our reliance on external sources. Two, rather than focusing on a single market for all our products, we target multiple global markets. This approach mitigates risks associated with market fluctuations and regulatory changes.Additionally, we place significant emphasis on delivering new and distinctive products. By offering a unique product portfolio, we set ourselves apart from our competitors, establish a competitive advantage and attract a broader customer base. 

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    #SpeakPharma With Biophore
    30 Sep 2023
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    VLOG #PharmaReel

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    ReelPharmaResearch. Innovation. CollaborationResearch. Innovation. Collaboration

    Research. Innovation. Collaboration
    Research. Innovation. Collaboration

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    A trusted partner for expedited development of niche pharmaceuticals like peptides and injectable API’s globally with 200+ DMFs and 20+CEPs.

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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

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    Corporate Presentation

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    API Product List 2024

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    FDF Product List 2019

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    GMP Certificate 2017

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    DATA COMPILATION #PharmaFlow

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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

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    24 Oct 2024
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    NEWS #PharmaBuzz

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    Biophore, its subsidiary Zenara, receive first approval for Cannabidiol in India
    Biophore, its subsidiary Zenara, receive first approval for Cannabidiol in India

    15 May 2023

    // HEALTH ET

    https://health.economictimes.indiatimes.com/news/pharma/drug-approvals-launches/biophore-its-subsidiary-zenara-pharma-receive-first-approval-for-cannabidiol-in-india/100251790

    HEALTH ET
    15 May 2023
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    Akums enters into a joint association with Leiutis & Biophore
    Akums enters into a joint association with Leiutis & Biophore

    01 Dec 2022

    // ECONOMICTIMES

    https://health.economictimes.indiatimes.com/news/pharma/akums-enters-into-a-joint-association-with-leiutis-and-biophore-for-introducing-first-of-its-kind-therapeutics/95898429

    ECONOMICTIMES
    01 Dec 2022
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    Zenara Pharma Launches Generic Of Paxlovid For COVID-19 In India
    Zenara Pharma Launches Generic Of Paxlovid For COVID-19 In India

    09 Sep 2022

    // OUTLOOKINDIA

    https://www.outlookindia.com/business/zenara-pharma-launches-generic-of-paxlovid-for-covid-19-in-india-news-222189

    OUTLOOKINDIA
    09 Sep 2022
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    Ani Pharma Announces Launch of Prochlorperazine Maleate Tablets
    Ani Pharma Announces Launch of Prochlorperazine Maleate Tablets

    29 Aug 2022

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20220829005136/en

    BUSINESSWIRE
    29 Aug 2022
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    Biophore receives sub-license from MPP for molnupiravir for Covid
    Biophore receives sub-license from MPP for molnupiravir for Covid

    21 Jan 2022

    // PHARMABIZ

    http://www.pharmabiz.com/NewsDetails.aspx?aid=145366&sid=2

    PHARMABIZ
    21 Jan 2022
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    Biophore to manufacture indigenous ingredients of Pfizer’s COVID-19 drug
    Biophore to manufacture indigenous ingredients of Pfizer’s COVID-19 drug

    21 Jan 2022

    // BIOSPECTRUMASIA

    https://www.biospectrumindia.com/news/95/20420/biophore-to-manufacture-indigenous-ingredients-of-pfizers-covid-19-drug.html

    BIOSPECTRUMASIA
    21 Jan 2022
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    ALL APIs

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    01

    Mexiletine

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-09-01

    Pay. Date : 2020-08-06

    DMF Number : 34668

    Submission : 2020-03-06

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2020-384 - Rev 00

    Issue Date : 2022-05-17

    Type : Chemical

    Substance Number : 1029

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-0511

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 73435-007

    Start Marketing Date : 2020-02-10

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    02

    Naphazoline Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35833

    Submission : 2021-04-29

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2022-117 - Rev 00

    Issue Date : 2023-11-27

    Type : Chemical

    Substance Number : 730

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-0511

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 73435-014

    Start Marketing Date : 2021-11-18

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

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    03

    Chlorambucil

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-12-01

    Pay. Date : 2015-09-09

    DMF Number : 28956

    Submission : 2015-05-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-136 - Rev 01

    Issue Date : 2024-02-22

    Type : Chemical

    Substance Number : 137

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Biophore

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    #PipelineProspector

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    04

    Clomipramine Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-10-21

    Pay. Date : 2016-08-22

    DMF Number : 30814

    Submission : 2016-08-20

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2017-288 - Rev 01

    Issue Date : 2023-05-15

    Type : Chemical

    Substance Number : 889

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Biophore

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    05

    Ethacrynic Acid

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-12-17

    Pay. Date : 2015-09-08

    DMF Number : 29429

    Submission : 2015-06-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-288 - Rev 01

    Issue Date : 2025-02-19

    Type : Chemical

    Substance Number : 457

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Biophore

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    06

    Isoproterenol Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-10-06

    Pay. Date : 2016-08-22

    DMF Number : 30811

    Submission : 2016-08-13

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2017-180 - Rev 00

    Issue Date : 2023-07-05

    Type : Chemical

    Substance Number : 1332

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Biophore

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    07

    Melphalan

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-10

    Pay. Date : 2014-05-28

    DMF Number : 28300

    Submission : 2014-05-24

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-238 - Rev 01

    Issue Date : 2024-01-31

    Type : Chemical

    Substance Number : 1698

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Biophore

    Product
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    08

    Nilutamide

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-03-12

    Pay. Date : 2014-12-24

    DMF Number : 28262

    Submission : 2014-06-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-225 - Rev 01

    Issue Date : 2024-02-28

    Type : Chemical

    Substance Number : 2256

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Biophore

    Product
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    09

    Permethrin

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    iPHEX India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-03-25

    Pay. Date : 2016-02-22

    DMF Number : 30243

    Submission : 2016-02-13

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-335 - Rev 01

    Issue Date : 2023-05-15

    Type : Chemical

    Substance Number : 1762

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Biophore

    Product
    Web Link

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    10

    Tretinoin

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    iPHEX India
    Attending
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-03

    Pay. Date : 2013-03-19

    DMF Number : 26922

    Submission : 2013-03-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-124 - Rev 00

    Issue Date : 2021-07-01

    Type : Chemical

    Substance Number : 693

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Biophore

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    USDMF

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    01

    Acrivastine

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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-12-15

    Pay. Date : 2015-09-29

    DMF Number : 29830

    Submission : 2015-09-29

    Status : Active

    Type : II

    Biophore

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    02

    Alosetron Hydrochloride

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-02-28

    Pay. Date : 2013-09-25

    DMF Number : 27470

    Submission : 2013-09-23

    Status : Active

    Type : II

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    03

    Aminocaproic Acid

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-05-16

    Pay. Date : 2017-04-27

    DMF Number : 31478

    Submission : 2017-04-26

    Status : Active

    Type : II

    Biophore

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    04

    Asciminib Hydrochloride Premix-i

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41393

    Submission : 2025-02-28

    Status : Active

    Type : II

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    05

    Avatrombopag Maleate

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41015

    Submission : 2024-12-28

    Status : Active

    Type : II

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    06

    Belinostat

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32405

    Submission : 2018-04-11

    Status : Active

    Type : II

    Biophore

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    07

    Bempedoic Acid

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38786

    Submission : 2023-12-28

    Status : Active

    Type : II

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    08

    Bendamustine Hydrochloride Monohydra...

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-02-24

    Pay. Date : 2013-09-25

    DMF Number : 27483

    Submission : 2013-09-20

    Status : Active

    Type : II

    Biophore

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    09

    Bilastine

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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39332

    Submission : 2023-12-29

    Status : Active

    Type : II

    Biophore

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    10

    Bortezomib

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-12-04

    Pay. Date : 2015-09-09

    DMF Number : 29506

    Submission : 2015-08-27

    Status : Active

    Type : II

    Biophore

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    CEP/COS

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    01

    all-rac-Phytomenadione

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Certificate Numbers : R0-CEP 2017-243 - Rev 01

    Status : Valid

    Issue Date : 2022-03-22

    Type : Chemical

    Substance Number : 3011

    Biophore

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    02

    Amidotrizoic Acid Dihydrate

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Certificate Numbers : CEP 2017-186 - Rev 01

    Status : Valid

    Issue Date : 2024-08-05

    Type : Chemical

    Substance Number : 873

    Biophore

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    03

    Chlorambucil

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Certificate Numbers : CEP 2017-136 - Rev 01

    Status : Valid

    Issue Date : 2024-02-22

    Type : Chemical

    Substance Number : 137

    Biophore

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    04

    Chlorpromazine hydrochloride

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Certificate Numbers : R0-CEP 2021-266 - Rev 00

    Status : Valid

    Issue Date : 2023-03-08

    Type : Chemical

    Substance Number : 475

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    05

    Cladribine

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Certificate Numbers : CEP 2022-078 - Rev 00

    Status : Valid

    Issue Date : 2024-06-03

    Type : Chemical

    Substance Number : 2174

    Biophore

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    06

    Clomipramine Hydrochloride

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Certificate Numbers : R0-CEP 2017-288 - Rev 01

    Status : Valid

    Issue Date : 2023-05-15

    Type : Chemical

    Substance Number : 889

    Biophore

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    07

    Diazoxide

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Certificate Numbers : R0-CEP 2019-298 - Rev 02

    Status : Valid

    Issue Date : 2023-05-15

    Type : Chemical

    Substance Number : 550

    Biophore

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    08

    Etacrynic Acid

    India
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    iPHEX India
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    Biophore India Pharmaceuticals Pvt Ltd

    Certificate Numbers : CEP 2018-288 - Rev 01

    Status : Valid

    Issue Date : 2025-02-19

    Type : Chemical

    Substance Number : 457

    Biophore

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    09

    Gadobutrol monohydrate

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Certificate Numbers : R0-CEP 2019-307 - Rev 01

    Status : Valid

    Issue Date : 2023-06-08

    Type : Chemical

    Substance Number : 2735

    Biophore

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    10

    Isoprenaline hydrochloride

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Certificate Numbers : R1-CEP 2017-180 - Rev 00

    Status : Valid

    Issue Date : 2023-07-05

    Type : Chemical

    Substance Number : 1332

    Biophore

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    EU WC

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    01

    Cannabidiol IH

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-0511

    Address of the Firm : Plot No. 80A, Road No.5, Jawah...

    Biophore

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    02

    Cannabidiol IH

    India
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    iPHEX India
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    Biophore India Pharmaceuticals Pvt Ltd

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-511n

    Address of the Firm : Plot No. 80A, Road No.5, Jawah...

    Biophore

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    03

    Dichlorphenamide IH

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-511n

    Address of the Firm : Plot No. 80A, Road No.5, Jawah...

    Biophore

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    04

    Dichlorphenamide IH

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-0511

    Address of the Firm : Plot No. 80A, Road No.5, Jawah...

    Biophore

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    05

    Favipiravir IH

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-511n

    Address of the Firm : Plot No. 80A, Road No.5, Jawah...

    Biophore

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    06

    Favipiravir IH

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-0511

    Address of the Firm : Plot No. 80A, Road No.5, Jawah...

    Biophore

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    07

    Fenoprofen Calcium IH

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-511n

    Address of the Firm : Plot No. 80A, Road No.5, Jawah...

    Biophore

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    08

    Fenoprofen Calcium IH

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-0511

    Address of the Firm : Plot No. 80A, Road No.5, Jawah...

    Biophore

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    09

    Gadoteridol IH

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-511n

    Address of the Firm : Plot No. 80A, Road No.5, Jawah...

    Biophore

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    10

    Gadoteridol IH

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-0511

    Address of the Firm : Plot No. 80A, Road No.5, Jawah...

    Biophore

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    NDC API

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    01

    BEMPEDOIC ACID

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    Biophore India Pharmaceuticals Pvt Ltd

    NDC Package Code : 73435-038

    Start Marketing Date : 2025-01-15

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    Biophore

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    02

    CALTERIDOL CALCIUM

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    NDC Package Code : 73435-016

    Start Marketing Date : 2021-12-08

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (5kg/5kg)

    Marketing Category : BULK INGREDIENT

    Biophore

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    03

    CANNABIDIOL

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    NDC Package Code : 73435-015

    Start Marketing Date : 2021-10-05

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (10kg/10kg)

    Marketing Category : BULK INGREDIENT

    Biophore

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    04

    CENOBAMATE

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    NDC Package Code : 73435-036

    Start Marketing Date : 2023-12-20

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (60kg/60kg)

    Marketing Category : BULK INGREDIENT

    Biophore

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    05

    CHLORPROMAZINE HYDROCHLORIDE

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    NDC Package Code : 73435-001

    Start Marketing Date : 2019-11-05

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    Biophore

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    06

    DICHLORPHENAMIDE

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    NDC Package Code : 73435-011

    Start Marketing Date : 2020-12-23

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (15kg/15kg)

    Marketing Category : BULK INGREDIENT

    Biophore

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    07

    EDARAVONE

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    NDC Package Code : 73435-008

    Start Marketing Date : 2020-12-23

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    Biophore

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    08

    ELAGOLIX SODIUM

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    Biophore India Pharmaceuticals Pvt Ltd

    NDC Package Code : 73435-021

    Start Marketing Date : 2021-12-08

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (20kg/20kg)

    Marketing Category : BULK INGREDIENT

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    09

    ERYTHROMYCIN LACTOBIONATE

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    Biophore India Pharmaceuticals Pvt Ltd

    NDC Package Code : 73435-006

    Start Marketing Date : 2020-02-10

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (10kg/10kg)

    Marketing Category : BULK INGREDIENT

    Biophore

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    10

    FAVIPIRAVIR

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    Biophore India Pharmaceuticals Pvt Ltd

    NDC Package Code : 73435-010

    Start Marketing Date : 2020-12-23

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (20kg/20kg)

    Marketing Category : BULK INGREDIENT

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    LISTED APIs

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    Acitretin

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    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among ...
    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
    Biophore

    01

    Acitretin

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

    About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufa...

    Biophore

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    Acrivastine

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    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among ...
    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
    Biophore

    02

    Acrivastine

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

    About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufa...

    Biophore

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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Agomelatine

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    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among ...
    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
    Biophore

    03

    Agomelatine

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

    About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufa...

    Biophore

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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Alosetron HCl

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    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among ...
    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
    Biophore

    04

    Alosetron HCl

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

    About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufa...

    Biophore

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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Aminocaproic Acid

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    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among ...
    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
    Biophore

    05

    Aminocaproic Acid

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

    About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufa...

    Biophore

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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Aviptadil Acetate

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    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among ...
    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
    Biophore

    06

    Aviptadil Acetate

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

    About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufa...

    Biophore

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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Belinostat

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    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among ...
    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
    Biophore

    07

    Belinostat

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

    About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufa...

    Biophore

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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Bempedoic Acid

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    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among ...
    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
    Biophore

    08

    Bempedoic Acid

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

    About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufa...

    Biophore

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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Bendamustine

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    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among ...
    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
    Biophore

    09

    Bendamustine

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

    About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufa...

    Biophore

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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Bortezomib

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    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among ...
    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
    Biophore

    10

    Bortezomib

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

    About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufa...

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    Drugs in Development

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    Biophore, Its Subsidiary Zenara Pharma, Receive First Approval for Cannabidiol in India

    Details:

    Cannabinoid oral solution has received approval for the treatment of several neurological disorders. It functions by stimulating two receptors, cannabinoid receptor type 1 and type 2, within the endocannabinoid system, maintaining body's homeostatis.


    Lead Product(s): Cannabidiol

    Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 15, 2023

    Biophore CB

    01

    Zenara Pharma

    India
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    Not Confirmed
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    Lead Product(s) : Cannabidiol

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Biophore, Its Subsidiary Zenara Pharma, Receive First Approval for Cannabidiol in India

    Details : Cannabinoid oral solution has received approval for the treatment of several neurological disorders. It functions by stimulating two receptors, cannabinoid receptor type 1 and type 2, within the endocannabinoid system, maintaining body's homeostatis.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    May 15, 2023

    Biophore CB

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    Zenara Launches Generic Version Of Pfizer Covid Drug Paxlovid

    Details:

    Paxzen (nirmatrelvir) is an oral protease inhibitor that is active against MPRO, a viral protease that plays an essential role in viral replication by cleaving the 2 viral polyproteins.


    Lead Product(s): Nirmatrelvir,Ritonavir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxzen

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 09, 2022

    Biophore

    02

    Biophore India Pharmaceuticals Pvt Ltd

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Lead Product(s) : Nirmatrelvir,Ritonavir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Zenara Launches Generic Version Of Pfizer Covid Drug Paxlovid

    Details : Paxzen (nirmatrelvir) is an oral protease inhibitor that is active against MPRO, a viral protease that plays an essential role in viral replication by cleaving the 2 viral polyproteins.

    Product Name : Paxzen

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    September 09, 2022

    Biophore

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    Zenara Pharma to Launch Generic Paxlovid Soon

    Details:

    Zenara said Nirmatrelvir and Ritonavir tablets will soon be available in a combi-pack, sold under the brand name Paxzen, as a treatment of mild-to-moderate Covid-19 in adults.


    Lead Product(s): Nirmatrelvir,Ritonavir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxzen

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Pfizer Inc

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 28, 2022

    Biophore CB

    03

    Zenara Pharma

    India
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    Not Confirmed
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    Lead Product(s) : Nirmatrelvir,Ritonavir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Pfizer Inc

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Zenara Pharma to Launch Generic Paxlovid Soon

    Details : Zenara said Nirmatrelvir and Ritonavir tablets will soon be available in a combi-pack, sold under the brand name Paxzen, as a treatment of mild-to-moderate Covid-19 in adults.

    Product Name : Paxzen

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    July 28, 2022

    Biophore CB

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    Biophore Receives Sub-License From MPP to Manufacture and Market Molnupiravir for Covid Treatment

    Details:

    The licences are applicable for both molnupiravir (API) and finished product in capsules form. It enables the company to launch the product within India as well as export to 104 other countries around the world, Biophore India Pharmaceuticals said in a statement.


    Lead Product(s): Molnupiravir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: MK-4482

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: The Medicines Patent Pool

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement January 20, 2022

    Biophore

    04

    Biophore India Pharmaceuticals Pvt Ltd

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Lead Product(s) : Molnupiravir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : The Medicines Patent Pool

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Biophore Receives Sub-License From MPP to Manufacture and Market Molnupiravir for Covid Treatment

    Details : The licences are applicable for both molnupiravir (API) and finished product in capsules form. It enables the company to launch the product within India as well as export to 104 other countries around the world, Biophore India Pharmaceuticals said in a s...

    Product Name : MK-4482

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    January 20, 2022

    Biophore

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    Hyderabad's Biophore To Manufacture Ingredients of Pfizer's Covid Drug

    Details:

    Paxlovid (Nirmatrelvir) is an oral protease inhibitor that is active against MPRO, a viral protease that plays an essential role in viral replication by cleaving the 2 viral polyproteins.


    Lead Product(s): Nirmatrelvir,Ritonavir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxlovid

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 19, 2022

    Biophore

    05

    Biophore India Pharmaceuticals Pvt Ltd

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    Lead Product(s) : Nirmatrelvir,Ritonavir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Hyderabad's Biophore To Manufacture Ingredients of Pfizer's Covid Drug

    Details : Paxlovid (Nirmatrelvir) is an oral protease inhibitor that is active against MPRO, a viral protease that plays an essential role in viral replication by cleaving the 2 viral polyproteins.

    Product Name : Paxlovid

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    January 19, 2022

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    Biophore Applies For DCGI Approval for Emergency Use of Aviptadil to Treat COVID-19

    Details:

    Biophore has developed Aviptadil and is backward integrated with in-house API. The company has also informed that it will be commencing commercial production immediately after the approval is received.


    Lead Product(s): Aviptadil Acetate

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Peptide

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 06, 2021

    Biophore

    06

    Biophore India Pharmaceuticals Pvt Ltd

    India
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    Lead Product(s) : Aviptadil Acetate

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Biophore Applies For DCGI Approval for Emergency Use of Aviptadil to Treat COVID-19

    Details : Biophore has developed Aviptadil and is backward integrated with in-house API. The company has also informed that it will be commencing commercial production immediately after the approval is received.

    Product Name : Undisclosed

    Product Type : Peptide

    Upfront Cash : Inapplicable

    November 06, 2021

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    Biophore seeks DCGI Emergency Use Approval of Aviptadil for Covid-19

    Details:

    Aviptadil is a synthetic form of vasoactive intestinal peptide (VIP) that, when administered, results in rapid clinical recovery in patients with severe SARS-COV-2 infection. Biophore has successfully developed aviptadil and is backward integrated with in-house API.


    Lead Product(s): Aviptadil Acetate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Peptide

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 06, 2021

    Biophore

    07

    Biophore India Pharmaceuticals Pvt Ltd

    India
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    Lead Product(s) : Aviptadil Acetate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Biophore seeks DCGI Emergency Use Approval of Aviptadil for Covid-19

    Details : Aviptadil is a synthetic form of vasoactive intestinal peptide (VIP) that, when administered, results in rapid clinical recovery in patients with severe SARS-COV-2 infection. Biophore has successfully developed aviptadil and is backward integrated with i...

    Product Name : Undisclosed

    Product Type : Peptide

    Upfront Cash : Inapplicable

    November 06, 2021

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    Hyderabad Based Biophore India Gets DCGI Nod To Manufacture COVID Drug Favipiravir

    Details:

    Favipiravir is an antiviral agent that was initially discovered and developed because of its activity against another RNA (ribonucleic acid) virus, the influenza virus.


    Lead Product(s): Favipiravir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 14, 2020

    Biophore

    08

    Biophore India Pharmaceuticals Pvt Ltd

    India
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    Attending
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    Lead Product(s) : Favipiravir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Hyderabad Based Biophore India Gets DCGI Nod To Manufacture COVID Drug Favipiravir

    Details : Favipiravir is an antiviral agent that was initially discovered and developed because of its activity against another RNA (ribonucleic acid) virus, the influenza virus.

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    July 14, 2020

    Biophore

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    Zenara Pharma, a Biophore Subsidiary, Gets DCGI Nod for Favipiravir Tablets

    Details:

    Favipiravir tablets will be sold under the brand name ‘Favizen’, is being manufactured at Zenara’s US FDA approved facility in Hyderabad.


    Lead Product(s): Favipiravir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Favizen

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 08, 2020

    Biophore CB

    09

    Zenara Pharma

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    Lead Product(s) : Favipiravir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Zenara Pharma, a Biophore Subsidiary, Gets DCGI Nod for Favipiravir Tablets

    Details : Favipiravir tablets will be sold under the brand name ‘Favizen’, is being manufactured at Zenara’s US FDA approved facility in Hyderabad.

    Product Name : Favizen

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    May 08, 2020

    Biophore CB

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    Zenara Pharma Receives DCGI Approval to Manufacture, Sell Favipiravir Tablets

    Details:

    Zenara Pharma has received approval from the Drugs Controller General of India (DCGI), to manufacture and sell Favipiravir tablets as a treatment option for patients with mild to moderate symptoms of COVID-19.


    Lead Product(s): Favipiravir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Favizen

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 08, 2020

    Biophore CB

    10

    Zenara Pharma

    India
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    Lead Product(s) : Favipiravir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Zenara Pharma Receives DCGI Approval to Manufacture, Sell Favipiravir Tablets

    Details : Zenara Pharma has received approval from the Drugs Controller General of India (DCGI), to manufacture and sell Favipiravir tablets as a treatment option for patients with mild to moderate symptoms of COVID-19.

    Product Name : Favizen

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    May 08, 2020

    Biophore CB

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    Brand Name : N/A

    India
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    Attending
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Regulatory Info :

    Registration Country : India

    Acrivastine

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Capsule

    Brand Name :

    Dosage Strength : 8MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Biophore

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    Regulatory Info :

    Registration Country : India

    Acrivastine

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Capsule

    Brand Name :

    Dosage Strength : 60MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Biophore

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    03

    Brand Name : N/A

    India
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    Regulatory Info :

    Registration Country : India

    Alpha-Methyltyrosine

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Capsule

    Brand Name :

    Dosage Strength : 250MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Biophore

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    Brand Name : BREXPIPRAZOLE

    India
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    Indo Livestock Expo
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    Regulatory Info :

    Registration Country : USA

    BREXPIPRAZOLE

    Zenara Pharma

    Dosage Form : TABLET;ORAL

    Brand Name : BREXPIPRAZOLE

    Dosage Strength : 0.5MG

    Packaging :

    Approval Date :

    Application Number : 213477

    Regulatory Info :

    Registration Country : USA

    Biophore CB

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    Brand Name : BREXPIPRAZOLE

    India
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    Regulatory Info :

    Registration Country : USA

    BREXPIPRAZOLE

    Zenara Pharma

    Dosage Form : TABLET;ORAL

    Brand Name : BREXPIPRAZOLE

    Dosage Strength : 2MG

    Packaging :

    Approval Date :

    Application Number : 213477

    Regulatory Info :

    Registration Country : USA

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    Brand Name : BREXPIPRAZOLE

    India
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    Regulatory Info :

    Registration Country : USA

    BREXPIPRAZOLE

    Zenara Pharma

    Dosage Form : TABLET;ORAL

    Brand Name : BREXPIPRAZOLE

    Dosage Strength : 4MG

    Packaging :

    Approval Date :

    Application Number : 213477

    Regulatory Info :

    Registration Country : USA

    Biophore CB

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    Brand Name : BREXPIPRAZOLE

    India
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    Regulatory Info :

    Registration Country : USA

    BREXPIPRAZOLE

    Zenara Pharma

    Dosage Form : TABLET;ORAL

    Brand Name : BREXPIPRAZOLE

    Dosage Strength : 0.25MG

    Packaging :

    Approval Date :

    Application Number : 213477

    Regulatory Info :

    Registration Country : USA

    Biophore CB

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    Brand Name : BREXPIPRAZOLE

    India
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    Regulatory Info :

    Registration Country : USA

    BREXPIPRAZOLE

    Zenara Pharma

    Dosage Form : TABLET;ORAL

    Brand Name : BREXPIPRAZOLE

    Dosage Strength : 1MG

    Packaging :

    Approval Date :

    Application Number : 213477

    Regulatory Info :

    Registration Country : USA

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    Brand Name : BREXPIPRAZOLE

    India
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    Regulatory Info :

    Registration Country : USA

    BREXPIPRAZOLE

    Zenara Pharma

    Dosage Form : TABLET;ORAL

    Brand Name : BREXPIPRAZOLE

    Dosage Strength : 3MG

    Packaging :

    Approval Date :

    Application Number : 213477

    Regulatory Info :

    Registration Country : USA

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    Brand Name : N/A

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    Regulatory Info :

    Registration Country : India

    Chlorpromazine Hydrochloride

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Tablet

    Brand Name :

    Dosage Strength : 50MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    FDA Orange Book

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    01

    Brand Name : BREXPIPRAZOLE

    India
    Specialty & Agro Chemical
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    RLD :

    TE Code :

    BREXPIPRAZOLE

    Zenara Pharma

    Dosage Form : TABLET; ORAL

    Proprietary Name : BREXPIPRAZOLE

    Dosage Strength : 0.25MG

    Approval Date :

    Application Number : 213477

    RX/OTC/DISCN :

    RLD :

    TE Code :

    Biophore CB

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    Brand Name : BREXPIPRAZOLE

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    TE Code :

    BREXPIPRAZOLE

    Zenara Pharma

    Dosage Form : TABLET; ORAL

    Proprietary Name : BREXPIPRAZOLE

    Dosage Strength : 0.5MG

    Approval Date :

    Application Number : 213477

    RX/OTC/DISCN :

    RLD :

    TE Code :

    Biophore CB

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    Brand Name : BREXPIPRAZOLE

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    RLD :

    TE Code :

    BREXPIPRAZOLE

    Zenara Pharma

    Dosage Form : TABLET; ORAL

    Proprietary Name : BREXPIPRAZOLE

    Dosage Strength : 1MG

    Approval Date :

    Application Number : 213477

    RX/OTC/DISCN :

    RLD :

    TE Code :

    Biophore CB

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    Brand Name : BREXPIPRAZOLE

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    RLD :

    TE Code :

    BREXPIPRAZOLE

    Zenara Pharma

    Dosage Form : TABLET; ORAL

    Proprietary Name : BREXPIPRAZOLE

    Dosage Strength : 2MG

    Approval Date :

    Application Number : 213477

    RX/OTC/DISCN :

    RLD :

    TE Code :

    Biophore CB

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    Brand Name : BREXPIPRAZOLE

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    RLD :

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    BREXPIPRAZOLE

    Zenara Pharma

    Dosage Form : TABLET; ORAL

    Proprietary Name : BREXPIPRAZOLE

    Dosage Strength : 3MG

    Approval Date :

    Application Number : 213477

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    RLD :

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    Biophore CB

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    Brand Name : BREXPIPRAZOLE

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    RLD :

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    BREXPIPRAZOLE

    Zenara Pharma

    Dosage Form : TABLET; ORAL

    Proprietary Name : BREXPIPRAZOLE

    Dosage Strength : 4MG

    Approval Date :

    Application Number : 213477

    RX/OTC/DISCN :

    RLD :

    TE Code :

    Biophore CB

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    Brand Name : PRUCALOPRIDE SUCCINA...

    India
    Specialty & Agro Chemical
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    PRUCALOPRIDE SUCCINATE

    Zenara Pharma

    Dosage Form : TABLET; ORAL

    Proprietary Name : PRUCALOPRIDE SUCCINATE

    Dosage Strength : EQ 1MG BASE

    Approval Date :

    Application Number : 218795

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    RLD :

    TE Code :

    Biophore CB

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    Brand Name : PRUCALOPRIDE SUCCINA...

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    RLD :

    TE Code :

    PRUCALOPRIDE SUCCINATE

    Zenara Pharma

    Dosage Form : TABLET; ORAL

    Proprietary Name : PRUCALOPRIDE SUCCINATE

    Dosage Strength : EQ 2MG BASE

    Approval Date :

    Application Number : 218795

    RX/OTC/DISCN :

    RLD :

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    Biophore CB

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    Brand Name : SAFINAMIDE MESYLATE

    India
    Specialty & Agro Chemical
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    RLD :

    TE Code :

    SAFINAMIDE MESYLATE

    Zenara Pharma

    Dosage Form : TABLET; ORAL

    Proprietary Name : SAFINAMIDE MESYLATE

    Dosage Strength : EQ 50MG BASE

    Approval Date :

    Application Number : 215913

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    TE Code :

    Biophore CB

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    Brand Name : SAFINAMIDE MESYLATE

    India
    Specialty & Agro Chemical
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    RLD :

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    SAFINAMIDE MESYLATE

    Zenara Pharma

    Dosage Form : TABLET; ORAL

    Proprietary Name : SAFINAMIDE MESYLATE

    Dosage Strength : EQ 100MG BASE

    Approval Date :

    Application Number : 215913

    RX/OTC/DISCN :

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    TE Code :

    Biophore CB

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    Regulatory Info :

    Registration Country : India

    Acrivastine

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Capsule

    Brand Name :

    Dosage Strength : 8MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    Acrivastine

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Capsule

    Brand Name :

    Dosage Strength : 60MG

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    Alpha-Methyltyrosine

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Capsule

    Brand Name :

    Dosage Strength : 250MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    Chlorpromazine Hydrochloride

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Tablet

    Brand Name :

    Dosage Strength : 25MG

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    Regulatory Info :

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    Chlorpromazine Hydrochloride

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Tablet

    Brand Name :

    Dosage Strength : 50MG

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    Chlorpromazine Hydrochloride

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Tablet

    Brand Name :

    Dosage Strength : 100MG

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    Chlorpromazine Hydrochloride

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Tablet

    Brand Name :

    Dosage Strength : 200MG

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    Regulatory Info :

    Registration Country : India

    Chlorzoxazone

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Tablet

    Brand Name :

    Dosage Strength : 250MG

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    Chlorzoxazone

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Tablet

    Brand Name :

    Dosage Strength : 375MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    Chlorzoxazone

    Biophore India Pharmaceuticals Pvt Ltd

    Dosage Form : Tablet

    Brand Name :

    Dosage Strength : 500MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    KEY PRODUCTS

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    Services

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    API Manufacturing

    Discover their expertise for : API Manufacturing

    Drug Product Manufacturing

    Discover their expertise for : Drug Product Manufacturing

    API & Drug Product Development

    Discover their expertise for : API & Drug Product Development

    Excipients

    Discover the DDS // excipients from this company

    USDMF

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    01

    BETADEX SULFOBUTYL ETHER SOD...

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34905

    Submission : 2020-06-01

    Status : Active

    Type : IV

    Biophore

    Excipients Web Link

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    02

    CALCIUM GLUCONATE MONOHYDRAT...

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : Complete

    Rev. Date : 2024-10-08

    Pay. Date : 2024-09-22

    DMF Number : 39601

    Submission : 2024-04-30

    Status : Active

    Type : II

    Biophore

    Excipients Web Link

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    03

    CALCOBUTROL SODIUM

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35424

    Submission : 2020-12-04

    Status : Active

    Type : IV

    Biophore

    Excipients Web Link

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    04

    CALTERIDOL CALCIUM

    India
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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36149

    Submission : 2021-07-31

    Status : Active

    Type : IV

    Biophore

    Excipients Web Link

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    05

    SALCAPROZATE SODIUM

    India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40217

    Submission : 2024-07-22

    Status : Active

    Type : IV

    Biophore

    Excipients Web Link

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    Inspections and registrations

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    EDQM

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    01

    GMP Certified

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    Biophore India Pharmaceuticals Pvt Ltd

    Type : GMP Certificates

    Number : DK H 000844...

    EudraGMDP Key : 39773

    Country : India

    Issue Date : 2017-01-26

    Post Code : 500 051

    NCA Ref : 262761

    City : Hyderabad, Andhra Prade...

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    GMP Certified

    EU
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    Biophore India Pharmaceuticals Pvt Ltd

    Type : GMP Certificates

    Number : DK H 000428...

    EudraGMDP Key : 23201

    Country : India

    Issue Date : 2014-04-01

    Post Code : 500 051

    NCA Ref : 262761

    City : Hyderabad

    Biophore

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    GMP Certified

    EU
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    Attending

    Biophore India Pharmaceuticals Pvt Ltd

    Type : GMP Certificates

    Number : DK H 000428...

    EudraGMDP Key : 23202

    Country : India

    Issue Date : 2014-04-01

    Post Code : 500 051

    NCA Ref : 262761

    City : Hyderabad, Andhra Prade...

    Biophore

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    04

    GMP Certified

    EU
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    Biophore India Pharmaceuticals Pvt Ltd

    Type : GMP Certificates

    Number : DK H 000314...

    EudraGMDP Key : 18567

    Country : India

    Issue Date : 2013-04-12

    Post Code : 500 051

    NCA Ref : 262761

    City : Hyderabad, Andhra Prade...

    Biophore

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    05

    GMP Certified

    EU
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    Biophore India Pharmaceuticals Pvt Ltd

    Type : GMP Certificates

    Number : DK H 000072...

    EudraGMDP Key : 8130

    Country : India

    Issue Date : 2011-01-12

    Post Code : 500 051

    NCA Ref : 262761

    City : Hyderabad, Andhra Prade...

    Biophore

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    ABOUT THIS PAGE

    Contact Biophore India Pharmaceuticals Pvt Ltd and get a quotation

    Biophore India Pharmaceuticals Pvt Ltd is a supplier offers 177 products (APIs, Excipients or Intermediates).

    Find a price of Mexiletine bulk with DMF, CEP, WC offered by Biophore India Pharmaceuticals Pvt Ltd

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