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Imeglimin hydrochloride manufacturers

7 products found

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Country of origin : India

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7 products found

imeglimin hydrochloride

Tablets 500 mg, 1000 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #36201

Established in 2003, this manufacturer specializes in developing, manufacturing, and marketing a diverse portfolio of pharmaceutical products. As a CTD dossier owner and manufacturer, it holds WHO-GMP certification and complies with various international regulatory standards, including EFDA Ethiopia, PPB Kenya, FDA Philippines, NAFDAC Nigeria, DPM Ivory Coast, MOH Cambodia, and NMHPRA Afghanistan. The manufacturer operates two state-of-the-art WHO-GMP manufacturing units producing general category formulations such as tablets, oral liquids, capsules, and sachets. A new facility under its sister concern, operational since May, is compliant with USFDA, PIC/S, and UKMHRA guidelines. As a CTD dossier owner and manufacturer, its products are distributed across multiple countries worldwide.

imeglimin hydrochloride

Tablets 500 mg, 1000 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.

imeglimin hydrochloride

Tablets 500 mg, 1000 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP, WHO, PICS
Comments
RLD: Twymeeg
Manufacturer #21921

This CTD dossier owner and manufacturer of Active Pharmaceutical Ingredients (APIs), semi-finished formulations, and finished pharmaceutical products. They specialize in developing and supplying APIs and semi-finished formulations like Directly Compressible Granules (DCG) and pellets, primarily focusing on anti-diabetic products. Their key therapy areas include diabetes management. They offer a range of principal dosage forms including oral solids, liquids, and injectables. The company boasts state-of-the-art facilities that adhere to EU GMP standards. They have significant experience in manufacturing Metformin API and DC granules for global markets.

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