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Imeglimin hydrochloride manufacturers

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imeglimin hydrochloride

Tablets 500 mg, 1000 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP, Vietnam, Kenya, Myanmar, Chile, Nigeria, Uganda, Afghanistan, Cambodia, Yemen, Philippines, Salvador, Malawi
Manufacturer #19280
An India-based pharmaceutical manufacturer offering a broad portfolio of medicines and wellness-oriented products, including antibiotics, antifungals, pain-management drugs, nutraceuticals, supplements, and other dosage forms. Its operations cover development and manufacturing of oral solid and liquid dosage forms, including both non-betalactam and betalactam (e.g. penicillins and cephalosporins) products. The company states that its manufacturing plants are EU-GMP approved, and describes itself as committed to providing affordable, high-quality pharmaceutical products with global regulatory compliance, reaching markets across multiple continents.

Manufacturer usually replies in 12 days

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.

Manufacturer usually replies in 14 days

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.

Manufacturer usually replies in 37 days

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