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Country of origin : India

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4 products found

tirzepatide

Injection 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Manufacturer #1338

The company is a prominent player in the generic pharmaceutical industry with strong capabilities in research, development, manufacturing, and commercialization. It has received multiple GMP certifications from international regulatory bodies, such as those from Bavaria, Switzerland, Slovenia, and Mexico, underscoring its commitment to quality and global standards. Recognized for its innovation, the company has earned numerous product patents and prestigious awards, such as the Pharmexcil Patent Award. With ISO certifications for quality and environmental management, a robust infrastructure of five manufacturing facilities in India, and strategic partnerships for producing HIV/AIDS drugs, the company demonstrates a strong focus on expanding its global footprint and delivering affordable healthcare solutions.

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tirzepatide

Injection, pre-filled pen 2.5 mg/0.5 ml, 5 mg/0.5 ml, 7.5 mg/0.5 ml, 10 mg/0.5 ml, 12.5 mg/0.5 ml, 15 mg/0.5 ml

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA, EU GMP, WHO, MHRA, Canada
Comments
Dossier availability: North America, Canada, Europe, United Kingdom, Latin America, Emerging MarketStorage: 2 - 8 C
Manufacturer #16394
This healthcare company is a prominent player in the pharmaceutical industry, specializing in a wide range of products including Active Pharmaceutical Ingredients (APIs), Biosimilars, Injectables, Ophthalmics, Peptides, and Solid Orals. They have a strong presence in both domestic and international markets, particularly in the EU and North America. The company boasts a diverse portfolio across several key therapy areas, with particular strength in Cardiovascular health and Oral Anti-Diabetic (OAD) medications. Their manufacturing facilities adhere to stringent GMP certifications, ensuring high quality standards. They also hold numerous product patents, highlighting their commitment to innovation.

tirzepatide

Injection, pre-filled pen 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg - 0.5 ml

Dossier type
US CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA
Comments
Reference product: Mounjaro®
Manufacturer #15189
The company, which was founded in 1989, is involved in developing, manufacturing, and distributing a wide range of formulations for anti-infectives, cardiovascular, anti-diabetic, dermatological, and hormone treatment. The corporation has a global presence in 170 + countries, 60+ WHO-prequalified medications, and 3700+ product registrations.

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