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tiopronin

Injection 0.1 g

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
China
Manufacturer #26421

Established in China, this Manufacturer is a CTD dossier owner and manufacturer specializing in antiviral drugs, human protein therapies, and general pharmaceuticals. As a GMP manufacturer, it upholds rigorous GMP approvals and quality control across its production sites. With multiple advanced production lines, the Manufacturer ensures compliance with the highest industry standards. As a CTD dossier owner and manufacturer, it continues to expand its global reach through innovative pharmaceutical solutions.

 

Manufacturer usually replies in 4 days

tiopronin

Tablets, delayed release (DR) 100 mg, 300 mg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
United States
GMP approvals
FDA
Manufacturer #15120

Pharmaceutical company, based in San Antonio, Texas, which has been enhancing lives for over 75 years. They provide high-quality prescription, OTC products, and medical devices, focusing on women's health, urology, and dermatology. The core areas include Branded Pharmaceuticals, Generic Pharmaceuticals, and Contract Development and Manufacturing.

tiopronin

Tablets, enteric coated 100 mg, 300 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 9 days

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