Granules India Unit V facility receives USFDA EIR with 'No Action Indicated' status

Written by Ruchika Sharma Published On 2024-11-08T10:00:00+05:30 | Updated On 8 Nov 2024 10:00 AM IST

Hyderabad: Granules India Limited, a pharmaceutical manufacturing company, has announced that it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Unit V facility located at Jawaharlal Nehru Pharma City (JNPC), Anakapalli District, Parawada Mandal, Andhra Pradesh.

This follows an inspection conducted by the US FDA from April 8 to April 12, 2024. The US FDA inspection classified the facility as "No Action Indicated" (NAI), indicating compliance with current Good Manufacturing Practices (cGMP) standards and confirming that no further regulatory action is required.

"This outcome reflects the facility's high standards in the production of Active Pharmaceutical Ingredients (APIs) and Finished Dosages(FDs) for both oncology and non-oncology therapeutic areas," the release stated.

During the inspection, the FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit, which concluded with zero Form 483 observations.

"The successful completion of this US FDA inspection with zero observations and the subsequent receipt of the EIR with NAI status reflects our unwavering commitment to maintaining the highest quality standards in our manufacturing operations," said Dr. Krishna Prasad Chigurupati, Chairman & Managing Director.

Read also: Granules India appoints Ramraj Rangarajulu as President, Head of Formulations Operations

Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. The Company is among the few pharmaceutical companies in the world to be present across the manufacturing of the entire pharmaceutical value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs), Granules products are distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, US and UK. The Company has 10 manufacturing facilities out of which 8 are located in India and 2 are in the USA and has regulatory approvals from the US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751