Latest news with #Guaifenesin
The Hindu
4 hours ago
- Business
- The Hindu
Granules unit in Hyderabad, one of the largest globally for paracetamol API, under U.S. FDA scanner
Generic drugmaker Granules India's active pharmaceutical ingredients (API) manufacturing facility in Bonthapally, Hyderabad, has been issued an observation by the U.S. Food and Drug Administration (U.S. FDA). The Bonthapally facility is one of the world's largest single-site paracetamol API manufacturing plants by volume. Along with paracetamol APIs, the company has established Metformin and Guaifenesin API manufacturing plants in the same facility, Granules India said in an intimation to the stock exchanges on Friday. The U.S. FDA had inspected the facility, located in Sangareddy district, from June 16-20 and issued Form 483 with one observation. The company said it will respond to the observation within the stipulated time.
Business Upturn
8 hours ago
- Business
- Business Upturn
Granules India's Bonthapally facility completes US FDA inspection with one observation
By Aditya Bhagchandani Published on June 20, 2025, 16:28 IST Granules India announced on June 20, 2025, that its API Unit-I facility at Bonthapally, located in Sangareddy District near Hyderabad, has successfully completed a US FDA inspection conducted between June 16 and June 20. The inspection concluded with a single Form 483 observation. In an exchange filing, the company stated it would address the observation within the prescribed timeline. Granules emphasized that the Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing units by volume and also houses manufacturing plants for Metformin and Guaifenesin APIs. The company assured investors that the outcome will be managed in line with regulatory expectations. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
