Panacea Biotec gets GMP nod from Ukraine for Baddi facilities

Panacea Biotec today said it has received GMP compliance certificate from the Ukrainian regulator for its manufacturing facilities at Baddi, Himachal Pradesh.
The good manufacturing practises (GMP) certificate for Baddi facilities also comes with manufacturing authorisation for 22 medicinal products including four for oncology, Panacea Biotec said in a filing to BSE.
The authorisation is valid till June 24, 2020, it added.
"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 June 19-24, 2017," Panacea Biotec said.
Ukraine is a member of the Pharmaceutical Inspection Co- operation Scheme (PIC/S) which has 49 countries under its ambit, including those from Europe, Africa, America, Asia and Australasia, it added.

With this approval, registration of the 22 products can now be undertaken in all the 49 countries on a fast track basis, Panacea Biotec said.

"The certificate of GMP compliance received from Ukrainian authorities strengthens and opens 49 countries for company's 22 products which can be registered in an expeditious manner under the PIC/S mechanism," Panacea Biotec Joint MD Rajesh Jain said.
PIC/S brings about single window GMP certification facilitation, with provision to reduce duplication of inspections and enhance market access of the medicinal products among all member nations, the company said.
The products are in various therapeutic segments such as organ transplantation, diabetes management, oncology, piles management, pain management and gastroenterology, it added.

Shares of Panacea Biotec today closed at Rs 234.55 per scrip, up 4.11 per cent from the previous close.