Granules India's US Packaging Facility Secures USFDA EIR with Zero Observations

The USFDA conducted an inspection at the company’s packaging facility located in Manassas from December 1 to December 3, 2025. The inspection concluded with zero observations, resulting in the issuance of an EIR with NAI status, indicating that the regulator did not identify any objectionable conditions during the inspection.

This marks the second successful USFDA inspection for the facility. The previous audit conducted in March 2023 also concluded with zero observations, reinforcing the facility’s regulatory compliance and quality standards.

Commenting on the development, Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, said, "Granules Consumer Health plays a critical role in our global operations as a packaging and distribution site. We process controlled substances and over-the-counter (OTC) products across three advanced packaging lines. Achieving zero observations in this inspection reflects the strong culture of quality, safety and regulatory excellence demonstrated by our teams."

Granules Consumer Health functions as the front-end division for OTC products in the United States, supporting Granules India’s integrated pharmaceutical operations. The facility is responsible for packaging both prescription (Rx) and OTC products while also serving as a distribution hub for OTC medicines across the US market.

Headquartered in Hyderabad, Granules India is a vertically integrated pharmaceutical company engaged across the value chain, including Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), Finished Dosages (FDs), and peptides CDMO services. The company supplies products to over 300 customers across more than 80 countries and operates 11 manufacturing facilities globally, including sites in India, the United States, and Switzerland