April 17, 2026April 17, 2026 Shares of Aurobindo Pharma Limited edged up on 17 April after the company secured final approval from the US Food and Drug Administration for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. At 11:47 am, the stock was trading up…
Shares of Lupin Ltd were trading flat on 9 May after the company announced securing approval from the United States Food and Drug Administration (USFDA) for Raltegravir Tablets. In its regulatory filing, the company said, “The company. has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application…
February 28, 2025February 28, 2025 Shares of Granules India Ltd crashed 8% on Friday, 28 February, after the US Food and Drug Administration (US FDA) issued a warning notice to the company’s Gagillapur factory. In its regulatory filing, the company said, “On 26 February 2025, the US FDA issued…
February 25, 2025February 25, 2025 Gland Pharma Ltd announced on Tuesday, 25 February, that the U.S. Food and Drug Administration (USFDA) has completed a key inspection of its Andhra Pradesh facility. In a regulatory filing, the company stated that the USFDA conducted a pre-approval inspection (PAI) for sterile APIs…
February 14, 2025February 14, 2025 Zydus Lifesciences Ltd announced on Friday that the United States Food and Drug Administration (USFDA) has successfully completed an inspection of its Ahmedabad facility without any observations. The US health regulator inspected the company’s Topical Manufacturing site in Changodar, Ahmedabad, as part of a…
October 18, 2024October 18, 2024 Shares of Zydus Lifesciences were trading in the green and 1% higher on 18 October after the company received approval from the US Food and Drug Administration (USFDA) to manufacture Fludrocortisone Acetate Tablets USP, 0.1 mg. The Fludrocortisone Acetate Tablets USP, 0.1 mg, are…
October 4, 2024October 4, 2024 Shares of Indoco Remedies Ltd surged 3% on 4 October after the company announced receiving final approval from the US Food and Drug Administration (USFDA) for Cetirizine Hydrochloride Tablets 10 mg (OTC). In its regulatory filing, the company said that they have received final…
October 1, 2024October 1, 2024 Shares of Zydus Lifesciences were trading higher by 1% on 1 October after the company announced that it had received an ‘Establishment Inspection Report (EIR)’ from the USFDA (United States Food and Drug Administration). The US health regulator conducted an inspection at the company’s…
August 30, 2024August 30, 2024 Shares of Torrent Pharmaceuticals Ltd surged 4% on Friday 30 August, reaching a fresh high of Rs 3,574 on the NSE. This was following the US drug regulator’s issuance of an Establishment Inspection Report (EIR) for the company’s manufacturing plant located in Indrad, Gujarat….
August 23, 2024August 23, 2024 Shares of Wanbury Ltd surged 5% on 23 August after the company announced receiving an Establishment Inspection Report (EIR) with zero form 483 observations from the United States Food and Drug Administration (USFDA) for its manufacturing facility located at MIDC Industrial Area in Patalganga,…