Biophore India Pharmaceuticals Pvt Ltd | NDC API | Active Pharmaceutical Ingredients

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

15 May 2023

// HEALTH ET

Akums enters into a joint association with Leiutis and Biophore for introducing first-of-its-kind therapeutics

01 Dec 2022

// ECONOMICTIMES

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

09 Sep 2022

// OUTLOOKINDIA

DATA COMPILATION
#PharmaFlow

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CPhI India 2024

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DIGITAL CONTENT

1 INTERVIEW #SpeakPharma, 1 VLOG #PharmaReel, 8 CORPORATE CONTENT #SupplierSpotlight, 23 NEWS #PharmaBuzz

media
1 INTERVIEW #SpeakPharma
1 VLOG #PharmaReel
8 CORPORATE CONTENT #SupplierSpotlight
23 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

162 All APIs, 128 USDMF, 25 CEP/COS, 10 EU WC, 30 NDC API, 133 Listed APIs

162 All APIs
128 USDMF
25 CEP/COS
10 EU WC
30 NDC API
133 Listed APIs

DEVELOPMENTS

10 Drugs in Development

10 Drugs in Development

FINISHED DOSAGE FORMULATIONS

77 FDF Dossiers, 15 FDA Orange Book, 62 Listed Dossiers

77 FDF Dossiers
15 FDA Orange Book
62 Listed Dossiers

INTERMEDIATES

4 All Intermediates

4 All Intermediates

KEY PRODUCTS

Cannabidiol, Cetrorelix Acetate, Cladribine, Cysteamine Bitartrate, Cysteamine Hydrochloride, Cysteamine S-phosphate, DOTA, Edaravone, Gadobutrol, Gadoteridol, Glycerol Phenylbutyrate, Iohexol, Mexiletine, Naphazoline Hydrochloride, Naphazoline Nitrate, Nelarabine, Nirmatrelvir, Procainamide, Procainamide Hydrochloride, Prochlorperazine, Prochlorperazine Edisylate, Prochlorperazine Maleate, Prochlorperazine Mesylate, Prucalopride Succinate, Regadenoson Monohydrate, Sapropterin Hydrochloride, Sodium Thiosulfate, Temozolomide, Valsartan

SERVICES

API Manufacturing, Drug Product Manufacturing, API & Drug Product Development

pharmaServices
API Manufacturing
Drug Product Manufacturing
API & Drug Product Development
- 2 API Development
- 3 Formulation Development

EXCIPIENTS

4 All Excipients, 4 USDMF

excipientPortfolio
4 All Excipients
4 USDMF

INSPECTIONS & REGISTRATIONS

4 EDQM, 2 GDUFA

inspections
4 EDQM
2 GDUFA

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

About

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

CPhI India 2024CPhI India 2024

Industry Trade Show

Attending

26-28 November, 2024

India Expo Centre, Greater Noida
IPEX IndonesiaIPEX Indonesia

Industry Trade Show

Not Confirmed

09-12 October, 2024

Jakarta, Indonesia
AllPack Indonesia 2024AllPack Indonesia 2024

Industry Trade Show

Not Confirmed

09-12 October, 2024

JIExpo Kemayoran, Jakarta - Indonesia

CONTACT DETAILS

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Country

India

Address

Plot#92;1-98/2/92, Kavuri Hills –Phase II, Jubilee Hills,Hyderabad 33,Telang...

Telephone

+91 4047474545

info@biophore.com

Website

http://www.biophore.com/

https://www.linkedin.com/company/biophore-india-pharmaceuticals-pvt-ltd

YouTube

Digital content

Explore the latest content creation from this company

INTERVIEW #SpeakPharma

“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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