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Elagolix manufacturers

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Country of origin : India

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4 products found

elagolix

Tablets 150 mg, 200 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #261
A pharmaceutical manufacturer based in the EU that has been selling its products in Europe for 20+ years. Main therapeutic areas include diabetes, CNL, dermatology, and oncology. Main dosage forms include solid and liquid oral, sterile dosage forms, and ointments. The company possesses 10+ manufacturing facilities that are cGMP-compliant.

Manufacturer usually replies in 6 days

elagolix

Tablets 150 mg, 200 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #34252

Established in 2004, this vertically integrated pharmaceutical manufacturer is committed to delivering high-quality, affordable medicines globally. As a CTD dossier owner and manufacturer, it holds GMP certifications from the US FDA, EU, and WHO, ensuring compliance with stringent international quality standards. The company's state-of-the-art R&D center is capable of handling oral solids, liquids, and parenteral formulations. Its products have received marketing authorizations from regulatory authorities such as the US FDA, Health Canada, CDSCO-India, and New Zealand. With over 20 ANDA/ANDs under approval, the manufacturer operates advanced production lines adhering to rigorous GMP guidelines. Its diverse portfolio includes therapeutics in areas like antivirals, neurology, women's health, cardiology, and imaging contrast agents.

Manufacturer usually replies in 2 days

elagolix

Tablets, immediate release (IR) 150 mg, 200 mg

Dossier type
US CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA
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.

Manufacturer usually replies in 11 days

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