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Country of origin : India
None products found

aspirin + dipyridamole

Capsules 25 mg + 200 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Manufacturer #36459

Established in 2018, this manufacturer employs approximately 653 individuals and specializes in offering end-to-end solutions in the pharmaceutical and specialty chemicals industries. As a CTD dossier owner and manufacturer, it holds GMP approvals from multiple international regulatory authorities, including the U.S. FDA, the Therapeutic Goods Administration (TGA) of Australia, and the Malta Medicines Authority (European Union). Additionally, it has received Written Confirmation from the Central Drugs Standard Control Organization (CDSCO) in India, affirming compliance with EU GMP standards for active pharmaceutical ingredients. The manufacturer operates advanced production lines for active pharmaceutical ingredients (APIs) and formulations, adhering to rigorous GMP guidelines. As a CTD dossier owner and manufacturer, its products and services are utilized across various countries and regions worldwide. With a focus on innovation, efficiency, and agility, the manufacturer is committed to delivering high-standard products that enhance the quality of people's lives.

 

 

 

 

Manufacturer usually replies in 18 days

aspirin

Tablets 100 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP, WHO
Manufacturer #36540

Established in January 2010, this manufacturer specializes in the contract manufacturing of oral solid dosage forms for both pharmaceuticals and nutraceuticals. As a CTD dossier owner and manufacturer, it holds GMP approvals, ensuring compliance with international quality standards. The manufacturer operates advanced production lines for tablets, capsules, and sachets, adhering to stringent GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed in various countries worldwide. With a dedicated team experienced in formulation development, the manufacturer is committed to delivering high-quality and regulatory-compliant products

Manufacturer usually replies in 14 days

paracetamol + aspirin + caffeine

Tablets, immediate release (IR) 250 mg + 250 mg + 65 mg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
FDA
Comments
Manufacturing Unit : GIL Regulated and Sold : OTC
Manufacturer #7499
Vertically integrated pharmaceutical manufacturer with four decades of experience producing high-volume Rx and OTC APIs, formulation intermediates, and finished tablets, capsules, and sachets. Core portfolio includes analgesics, anti-diabetics, and cardiovascular products spanning paracetamol, metformin, and ibuprofen. US FDA and EU-GMP approved facilities supply North America and Europe.

Manufacturer usually replies in 21 days

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