gepirone Tablets, extended release (ER) 18.2 mg, 36.3 mg, 54.4 mg, 72.6 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Manufacturer #36397

Established in 2009, this manufacturer specializes in active pharmaceutical ingredients (APIs) and finished formulations, including tablets, capsules, and liquid orals. As a CTD dossier owner and manufacturer, it holds GMP certifications from international regulatory authorities, including the U.S. FDA and EU GMP, ensuring compliance with stringent quality standards. The manufacturer operates state-of-the-art production facilities in Vadodara and Vapi, India, adhering to rigorous GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed across various regions, including Europe, East Asia, South America, and the Middle East. With a strong focus on research and development, the manufacturer is committed to delivering high-quality pharmaceutical solutions to meet global healthcare needs.

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