Granules India Share Price Gains Over 2%; Subsidiary Receives FDA No Action Indicated EIR for US Packaging Facility

Granules India Limited announced that its US step down subsidiary, Granules Consumer Health LLC, has received a No Action Indicated Establishment Inspection Report from the US Food and Drug Administration. 

FDA Inspection Outcome 

The FDA inspection took place at the company’s packaging site in Manassas, Virginia, from Dec 1 to 3, 2025. The report, issued on March 5, 2026, recorded zero observations, marking the second successful inspection after a similar result in March 2023. 

Role of Granules Consumer Health in US Operations 

Granules Consumer Health serves as Granules’ front‑end division for over the counter and prescription products in the United States.  

The facility handles controlled substances and over the counter items across three advanced packaging lines and also acts as a distribution hub for US markets. 

Read More: Glenmark Receives US FDA Approval for Fluticasone Propionate Inhalation Aerosol! 

Global Footprint and Regulatory Credentials 

Granules India operates 11 manufacturing sites – eight in India, two in the United States and one in Switzerland – and supplies products to over 300 customers across more than 80 countries.  

The group holds approvals from agencies including US FDA, EU GMP, WHO GMP, TGA and others. 

Company Overview 

Founded in 1991, Granules India is a vertically integrated pharmaceutical company producing active pharmaceutical ingredients, formulation intermediates, finished dosages and peptide CDMO services. Its operations span the entire value chain from raw material to finished product. 

Granules India Share Price Performance  

As of March 05, 2026, at 12:07 PM, Granules India share price on NSE was trading at ₹566.35 up by 2.16% from the previous closing price. 

Conclusion 

The No Action Indicated status reinforces Granules India’s focus on quality, safety and regulatory compliance at its US packaging facility, supporting its broader global manufacturing network. 

Disclaimer: This blog has been written exclusively for educational purposes. The securities or companies mentioned are only examples and not recommendations. This does not constitute a personal recommendation or investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions. 

Investments in the securities market are subject to market risks, read all the related documents carefully before investing.