Panacea Biotec gets Ukrainian regulator’s green signal for its 22 medicines

On the basis of this approval, the company can now fast track the registration of these 22 medicinal products in other 49 countries

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New Delhi: The Panacea Biotec has recently received the certificate of GMP compliance from State Service of Ukraine on Medicines and Drug Control with manufacturing authorization for 22 medicinal products, including 4 oncology products for a period valid till June 24, 2020.

Under this manufacturing authorization, the company’s oral solid dosage manufacturing facility and oncology facility at Baddi, Himachal Pradesh have been certified as complying with the Good Scheme (PIC/S) which has 49 countries from all over the world including Europe, Africa, America, Asia, and Australasia.

With this approval, registration of these 22 products can now be undertaken in the 49 PIC/S countries on a fast track basis as PIC/S brings about single window GMP Certification facilitation with provision to reduce duplication of inspections and enhance market access of the medical products amongst all member nations.

Ukraine is member of the association called PIC/S (Pharmaceutical Inspection Co- operation Scheme) which including countries like Europe, Africa, America, Asia and Australasia. On the basis of this approval the company can fast track registration of these medicines in 49 countries.

The 22 products under approval are in various therapeutic categories including organ transplantation, diabetes management, oncology, piles management, pain management and gastroenterology etc. Both the oral solid dosage manufacturing facility and oncology facility were inspected by the auditors from State Services of Ukraine on Medicines and Drug Control during the period from 19th June, 2017 to 24th June, 2017.

Panacea Biotec’s principal business activity include manufacturing of allopathic pharmaceuticals preparations. The company’s segments include vaccines, formulations, research and development; healthcare and real estate activities.