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Carglumic acid manufacturers

4 products found

Filters

4 products found

carglumic acid

Tablets, soluble 200 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Available for
Technology transfer
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 8 days

carglumic acid

Tablets, soluble 200 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
EU GMP
Manufacturer #361

It is a global player with more than half a century of experience. It has more than 4 facilities to operate from. They have marketing and promotion in more than 20 countries. It exports to more than 50 countries. The only motto is to improve the quality of human life and to provide access to reliable, high-quality products for human health worldwide. It is focused to create its own cadres in every country it operates.

Manufacturer usually replies in 35 days

carglumic acid

Tablets, orally disintegrating (ODT) 200 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
PICS
Manufacturer #2748

It is a privately held pharmaceutical company based in southeast Europe that was established in the 1990s to import and introduce pharmaceutical items into medicine. The company began by importing hemophilia and intensive care supplies, as well as immunoglobulin-containing items. To suit market demands, the company has added additional dermatological, cardiological, urological, and surgical goods to its portfolio since then. They now offer a diverse product line that includes not only prescription but also OTC, medical gadgets, and dermo-cosmetics.

Manufacturer usually replies in 31 days

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