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carglumic acid

Tablets, soluble 200 mg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
United States
GMP approvals
FDA
Manufacturer #32324
This company develops and manufactures novel, life-saving medicines. Their focus is on advancing technological innovation in pharmaceuticals. Their product portfolio includes prescription medications and potentially over-the-counter drugs across key therapy areas like oncology, infectious diseases, rare diseases, and central nervous system disorders. They likely utilize a range of dosage forms including oral solids, injectables, and topicals. The company holds GMP certifications and has obtained patents for its products. They operate in the EU and North America regions.

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

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