USFDA20 Jun 2025, 04:24 pm
Granules India's API Unit-I Receives US FDA Inspection with 1 Observation
AI Summary
Granules India Ltd.'s API Unit-I facility located at Bonthapally Village, Sangareddy District, Hyderabad, Telangana, India has undergone a US FDA inspection from June 16, 2025 to June 20, 2025. The inspection resulted in 1 (one) 483 observation. The company will respond to this observation within the stipulated time. This facility, one of the world’s largest single-site Paracetamol API manufacturing plants by volume, also houses Metformin and Guaifenesin API manufacturing plants.
Key Highlights
- Granules India's API Unit-I facility inspected by US FDA
- Inspection resulted in 1 (one) 483 observation
- Company to respond within stipulated time
- Facility is one of the world’s largest single-site Paracetamol API manufacturing plants by volume
- Facility also houses Metformin and Guaifenesin API manufacturing plants