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Tiopronin manufacturers

4 products found

Filters

4 products found

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 8 days

tiopronin

Injection 0.1 g

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
FDA
Unavailable markets
United States
Manufacturer #38346
Manufacturer was incorporated on 27 December 2021 in Surat, Gujarat, India, with about 28 employees. As a CTD dossier owner and manufacturer, it operates a WHO-GMP certified and EU-compliant formulation plant under CGMP norms. Products reach markets in India, Yemen, Zambia, Venezuela, Ghana, Kenya, and Tanzania for international presence. Designed to comply with rigorous “Revised Schedule M” rules from India’s Drug Controller. As a CTD dossier owner and manufacturer, it aims for regulatory readiness in global submissions. Recognized as a GMP manufacturer, it ensures standards of safety, purity, and efficacy in all batches.

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.

 

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