News | July 21, 2021
Granules clears US FDA audit
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
The company will engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.
The company has already embarked upon significant expansion in Turkey
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
The company has now received the renewed GMP (Good Manufacturing Practices) certificate thereby confirming the successful closure of the inspection
Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials will be manufactured in the company’s North American manufacturing facility based in Monroe, North Carolina
Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.’s Brovana
Shilpa's Paracetamol oral thin films are patent protected and are first of this kind in the world
The company expects to see steady performance led by new launches and gradual normalization post the scale-up in vaccination
In an exclusive interview with Rahul Koul of Indian Chemical News, Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals Inc. USA shared details about the company's performance, R&D initiatives, Capex plan, CSR, and future outlook. Excerpts of the interview:
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