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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

    09 Sep 2022

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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, 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”

    “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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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

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    API Product List 2024

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    FDF Product List 2019

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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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    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

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    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

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    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

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    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

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    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

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    21 Jan 2022
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