Granules India announced today that Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the Company located in Chantilly, Virginia, USA had undergone a Pre-Approval Inspection (PAI) audit by the U.S. Food and Drug Administration (FDA) from 21st June 2021 to 25th June 2021.
The audit is a pre-approval inspection for three of its applications filed from this facility. The FDA issued two minor observations during the audit.
Granules Clears FDA Pre-Inspection audit for its 3 applications
“The observations were responded to within the stipulated time, and we are happy to inform that the FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021. This is the fifth US FDA audit for this facility” said Ms. Priyanka Chigurupati, Executive Director, GPI.
The audit was triggered following Granules US subsidiary filing three abbreviated new drug applications from this facility.
The USFDA issued two minor observations during the audit, and the company had responded within the stipulated time.
This facility was inspected by the US FDA from 21st to 25th June 2021. The audit is a pre-approval inspection for three products filed from this facility. “We will be responding to the two observations within the stipulated time period,” Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals Inc in a statement earlier said.
GPI is a US FDA & DEA approved facility which spreads over 100,000 sq ft area, with established R&D & Manufacturing capabilities for low volume, oral solid dosage forms.
The Company produces Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) which gives the customers flexibility and choice. Granules support customers with unique value, extensive product range and proactive solutions.
Granules India along with its subsidiaries has a global presence which extends to over 250 customers in over 75 countries through its offices in India, U.S. & U.K. and has seven manufacturing facilities out of which six are located in India and one in the USA. Five out of these seven have regulatory approvals from the USFDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.