300+No of Products
22No of Countries
Regulatory Affairs is a highly competent team with strategic and tactical experience that manages the modern regulatory landscape by following regulatory practice, monitoring changing legislations and designing appropriate regulatory strategy and guidance for development and manufacture of products.It specialises in understanding the path ways and requirements of various regulatory authorities to work in collaboration with respective departments to generate first-time documentation for faster approvals and early launch of the products to create opportunities in a regulated environment.
More than 400 dossiers of quality, safety and efficacy are filed in both regional and CTD formats for different category of products in semi-regulated and emerging markets across the globe. More than 300 approvals received and working in tandem with Health Ministries ensure product life-cycle management and post-marketing surveillance. Regulatory Affairs ensures facilitation for cGMP, GCP and ISO regulatory inspections by various regulatory authorities and further maintenance of the approvals.
Out of 16 manufacturing facilities, 3 state-of-the-art WHO-and GMP-certified, and USFDA-compliant manufacturing units cater to requirement of exports:
Spread in a Total Area of 18000 Sq.metre, the unit manufactures Injectable (Both Vials & Ampoules). Unit I can manufacture 5mn Ampoules per month and 1.2 million vials per month.
It already has to its credit the following regulatory approvals: PICS / WHO GMP / PPB Kenya / Ethiopia / Uganda / Tanzania / Srilanka / Combodia
Spread in a Total Area of 25000 Sq.metre, the unit manufactures Dry syrup, Liquid syrups, Extended Release Tablets / Capsules, Bi-layered Tablets. Unit II can manufacture 30 million tablets per month, 70 million Soft gelatine capsules per month, 6 million bottles of oral liquid per month and 1 million dry powder per month.
It already has to its credit the following regulatory approvals: PICS / WHO GMP / PPB Kenya / Ethiopia/ Uganda / Srilanka / Combodia.
Spread in a Total Area of 3000 Sq.metre, the unit manufactures immediate release/ modified release tablets. Unit III can manufacture 60 million tablets per month.
It already has to its credit the following regulatory approvals: WHO GMP / PPB Kenya