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Country of origin : India
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fenofibric acid

Capsules, modified release (MR) 135 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
PICS
Manufacturer #31069

Established in 1981, this manufacturer specializes in developing, manufacturing, and marketing a diverse range of pharmaceutical products. As a CTD dossier owner and manufacturer, it holds GMP certifications from international regulatory authorities, including EU-GMP, WHO-cGMP, and approvals from Kenya and Uganda, ensuring compliance with stringent quality standards. The company operates two state-of-the-art manufacturing facilities, producing over 170 products across various therapeutic segments such as anti-hypertensives, anti-diabetics, lipid-lowering agents, anti-infectives, antibiotics, respiratory management, hematinics, anti-allergics, steroids, psychotropics, and vitamin supplements. As a CTD dossier owner and manufacturer, its products are distributed across multiple countries worldwide. With a dedicated R&D center recognized by the DSIR (Government of India), the manufacturer focuses on providing quality medicines with improved patient compliance through novel drug delivery systems.

 

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