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    Company profile for Biophore India Pharmaceuticals Pvt Ltd

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

    15 May 2023

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    Akums enters into a joint association with Leiutis & Biophore

    01 Dec 2022

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

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

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    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

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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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    30 Sep 2023
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    VLOG #PharmaReel

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    ReelPharmaResearch. Innovation. CollaborationResearch. 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 2025

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    API Product List 2025

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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 rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

    DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

    The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA 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.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 
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    13 Nov 2025
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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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    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

    // EXPRESS PHARMA

    https://www.expresspharma.in/zenara-pharma-launches-paxlovid-generic-for-covid-19-in-india/

    EXPRESS PHARMA
    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

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    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

    // BIOSPECTRUM

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

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    21 Jan 2022
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    USDMF

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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 : 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

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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

    Biophore

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    Aminocaproic Acid

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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

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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : Complete

    Rev. Date : 2025-06-20

    Pay. Date : 2025-05-29

    DMF Number : 41014

    Submission : 2024-12-31

    Status : Active

    Type : II

    Biophore

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    Asciminib Hydrochloride Premix-i

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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : Complete

    Rev. Date : 2025-06-25

    Pay. Date : 2025-05-29

    DMF Number : 41393

    Submission : 2025-02-28

    Status : Active

    Type : II

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    06

    Ataluren

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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 42714

    Submission : 2025-09-30

    Status : Active

    Type : II

    Biophore

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    Avatrombopag Maleate

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    Biophore India Pharmaceuticals Pvt Ltd

    GDUFA

    DMF Review : Complete

    Rev. Date : 2025-10-22

    Pay. Date : 2025-09-17

    DMF Number : 41015

    Submission : 2024-12-28

    Status : Active

    Type : II

    Biophore

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    08

    Belinostat

    India
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    CPhI North America
    Booth #1015
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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 : 32405

    Submission : 2018-04-11

    Status : Active

    Type : II

    Biophore

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    09

    Bempedoic Acid

    India
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    CPhI North America
    Booth #1015
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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 : 38786

    Submission : 2023-12-28

    Status : Active

    Type : II

    Biophore

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    10

    Bendamustine Hydrochloride Monohydra...

    India
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    Booth #1015
    • fda
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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 : 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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    Only 10 entries up to this point, click to access all click full view read-more
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    LISTED APIs

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

    Abemaciclib

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    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance r...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    01

    Abemaciclib

    India
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    CPhI North America
    Booth #1015
    • fda
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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, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 40...

    Biophore

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

    Acitretin

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    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance r...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    02

    Acitretin

    India
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    Booth #1015
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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, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 40...

    Biophore

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

    Acoramidis Hydrochloride

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    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance r...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    03

    Acoramidis Hydrochloride

    India
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    CPhI North America
    Booth #1015
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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, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 40...

    Biophore

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

    Acrivastine

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    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance r...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    04

    Acrivastine

    India
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    CPhI North America
    Booth #1015
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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, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 40...

    Biophore

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

    Adagrasib

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    Market
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    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance r...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    05

    Adagrasib

    India
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    CPhI North America
    Booth #1015
    • fda
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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, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 40...

    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, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance r...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    06

    Agomelatine

    India
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    CPhI North America
    Booth #1015
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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, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 40...

    Biophore

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

    Alosetron Hydrochloride

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    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance r...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    07

    Alosetron Hydrochloride

    India
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    CPhI North America
    Booth #1015
    • fda
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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, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 40...

    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, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance r...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    08

    Aminocaproic Acid

    India
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    CPhI North America
    Booth #1015
    • fda
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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, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 40...

    Biophore

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

    Amorolfine Hydrochloride

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    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance r...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    09

    Amorolfine Hydrochloride

    India
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    CPhI North America
    Booth #1015
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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, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 40...

    Biophore

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

    Apomorphine Hydrochloride

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    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance r...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    10

    Apomorphine Hydrochloride

    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, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 40...

    Biophore

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    Drugs in Development

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    Zenara Pharma Gets US FDA Nod for First Generic Sertraline Hydrochloride Capsules with 180-Day CGT Exclusivity

    Details:

    Sertraline HCl, a miscellaneous product targeting SSR, shows promising results in treating undisclosed Key Focus Area.


    Lead Product(s): Sertraline Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Sertraline-HCl

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 01, 2025

    Biophore CB

    01

    Zenara Pharma

    India
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    Lead Product(s) : Sertraline Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Zenara Pharma Gets US FDA Nod for First Generic Sertraline Hydrochloride Capsules with 180-Day CGT...

    Details : Sertraline HCl, a miscellaneous product targeting SSR, shows promising results in treating undisclosed Key Focus Area.

    Product Name : Sertraline-HCl

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 01, 2025

    Biophore CB

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

    ANI Pharmaceuticals Announces the Launch of Nitazoxanide Tablets

    Details:

    Alinia-Generic (nitazoxanide) is an antiprotozoal indicated for the treatment of diarrhea caused by giardia lamblia or cryptosporidium parvum.


    Lead Product(s): Nitazoxanide

    Therapeutic Area: Gastroenterology Brand Name: Alinia-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Recipient: ANI Pharmaceuticals Inc

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 19, 2025

    Biophore

    02

    Biophore India Pharmaceuticals Pvt Ltd

    India
    arrow
    CPhI North America
    Booth #1015
    • fda
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    • WHO-GMP
    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Lead Product(s) : Nitazoxanide

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved FDF

    Recipient : ANI Pharmaceuticals Inc

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    ANI Pharmaceuticals Announces the Launch of Nitazoxanide Tablets

    Details : Alinia-Generic (nitazoxanide) is an antiprotozoal indicated for the treatment of diarrhea caused by giardia lamblia or cryptosporidium parvum.

    Product Name : Alinia-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    March 19, 2025

    Biophore

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    Virtual Booth

    • Development Update
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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: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 15, 2023

    Biophore CB

    03

    Zenara Pharma

    India
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    PEGS Boston Summit
    Not Confirmed
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    Lead Product(s) : Cannabidiol

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    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: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 09, 2022

    Biophore CB

    04

    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 : Undisclosed

    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 : Miscellaneous

    Upfront Cash : Inapplicable

    September 09, 2022

    Biophore CB

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

    ANI Pharmaceuticals Announces the Launch of Prochlorperazine Maleate Tablets USP

    Details:

    The current annual U.S. market for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg is approximately $30.0 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.


    Lead Product(s): Prochlorperazine Maleate

    Therapeutic Area: Psychiatry/Psychology Brand Name: Prochlorperazine Maleate-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Recipient: ANI Pharmaceuticals Inc

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 29, 2022

    Biophore

    05

    Biophore India Pharmaceuticals Pvt Ltd

    India
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    Booth #1015
    • fda
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Lead Product(s) : Prochlorperazine Maleate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Recipient : ANI Pharmaceuticals Inc

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    ANI Pharmaceuticals Announces the Launch of Prochlorperazine Maleate Tablets USP

    Details : The current annual U.S. market for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg is approximately $30.0 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

    Product Name : Prochlorperazine Maleate-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 29, 2022

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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: Miscellaneous

    Sponsor: Pfizer Inc

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 28, 2022

    Biophore CB

    06

    Zenara Pharma

    India
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    PEGS Boston Summit
    Not Confirmed
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    • WHO-GMP
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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 : Miscellaneous

    Upfront Cash : Inapplicable

    July 28, 2022

    Biophore CB

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

    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: Undisclosed

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: The Medicines Patent Pool

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement January 20, 2022

    Biophore

    07

    Biophore India Pharmaceuticals Pvt Ltd

    India
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    Booth #1015
    • fda
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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 : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    January 20, 2022

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

    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, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 11, 2021

    Biophore

    08

    Biophore India Pharmaceuticals Pvt Ltd

    India
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    CPhI North America
    Booth #1015
    • fda
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Lead Product(s) : Aviptadil Acetate

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    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, Unconjugated

    Upfront Cash : Inapplicable

    June 11, 2021

    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: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 05, 2020

    Biophore CB

    09

    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 : Undisclosed

    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 : Miscellaneous

    Upfront Cash : Inapplicable

    August 05, 2020

    Biophore CB

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

    Cyclen (Intermediate)

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    294-90-6
    Gadobutrol
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    01

    Cyclen (Intermediate)

    India
    CPhI North America
    Booth #1015
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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

    Cyclen (Intermediate)

    CAS Number : 294-90-6

    End Use API : Gadobutrol

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-appro...

    Biophore

    Intermediate Web Link

    Market Place

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

    Cyclen (Intermediate)

    Intermediate Web Link

    Market Place

    294-90-6
    Gadoterate Meglumine
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    02

    Cyclen (Intermediate)

    India
    CPhI North America
    Booth #1015
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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

    Cyclen (Intermediate)

    CAS Number : 294-90-6

    End Use API : Gadoterate Meglumine

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-appro...

    Biophore

    Intermediate Web Link

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

    Cyclen (Intermediate)

    Intermediate Web Link

    Market Place

    294-90-6
    Gadoteridol
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    03

    Cyclen (Intermediate)

    India
    CPhI North America
    Booth #1015
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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

    Cyclen (Intermediate)

    CAS Number : 294-90-6

    End Use API : Gadoteridol

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-appro...

    Biophore

    Intermediate Web Link

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

    DOTA

    Intermediate Web Link

    Market Place

    60239-18-1
    Gadoterate Meglumine
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With...
    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

    04

    DOTA

    India
    CPhI North America
    Booth #1015
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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

    DOTA

    CAS Number : 60239-18-1

    End Use API : Gadoterate Meglumine

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-appro...

    Biophore

    Intermediate Web Link

    Market Place

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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

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    Excipients

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    All Excipients

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    01

    Calcium Gluconate Monohydrate Excip...

    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 Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-10-08

    Pay. Date : 2024-09-22

    DMF Number : 39601

    Submission : 2024-04-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Biophore

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    02

    Calcobutrol Sodium

    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35424

    Submission : 2020-12-04

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    Caloxetate Trisodium

    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 42373

    Submission : 2025-08-08

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    Calteridol Calcium

    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
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36149

    Submission : 2021-07-31

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 73435-016

    Start Marketing Date : 2021-12-08

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Biophore

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    05

    Salcaprozate Sodium

    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40217

    Submission : 2024-07-22

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Biophore

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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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    02

    GMP Certified

    EU
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    Booth #1015

    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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    03

    GMP Certified

    EU
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    Booth #1015

    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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    CPhI North America
    Booth #1015

    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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    CPhI North America
    Booth #1015

    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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

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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 214 products (APIs, Excipients or Intermediates).

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