This audit at the Unit V facility located at Anakapally, Visakhapatnam, Andhra Pradesh, was a Pre-Approval Inspection (PAI) and cGMP audit for Active Pharmaceutical Ingredients (APIs) and Formulations (FDs) for oncology and non-oncology products, a press release said.
Hyderabad: Three pharma companies from Hyderabad have entered into agreement with UN-backed Medicines Patent Pool (MPP), headquartered in Geneva, to manufacture and supply a generic version of Pfizer’s Covid-19 oral treatment Nirmatrelvir. Aurobindo Pharma said it signed a sub-license agreement with MPP. Earlier, MPP signed voluntary licensing agreement with Pfizer for sub-licensing this Covid-19 treatment […]
Hyderabad: Hyderabad headquartered Granules India announced that Granules Pharmaceuticals Inc (GPI), a wholly-owned foreign subsidiary of the company in Virginia, received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA). The GPI facility was inspected by the USFDA from January 24 to 28 for two of its product applications filed. There […]
Hyderabad: Hyderabad-based Granules India reported a 31.3 per cent decline in its net profit for the third quarter ended December 2021. The company’s profit stood at Rs 101 crore compared to Rs 147 crore reported during the corresponding period of the previous year. The dip in profit is driven by reduction in gross margin and […]
Hyderabad: Hyderabad-based Granules India said that Granules Pharmaceuticals, a wholly owned foreign subsidiary of the company, located in Chantilly, Virginia, USA had undergone a Pre-approval Inspection (PAI) by the US Food and Drug Administration (US FDA) from 24th to 28th January 2022. The audit is a PAI for two of its product applications filed from […]
Hyderabad: Granules India said on Friday that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India, for Potassium Chloride for Oral Solution USP, 20 mEq. Potassium chloride is used to prevent or to treat low […]
Hyderabad: Hyderabad-based Granules India, a vertically integrated pharmaceutical company, appointed Dr Saumen Chakraborty as non-executive independent director on the Board of the company with immediate effect. Dr Chakraborty retired as the president and chief financial officer of Dr Reddy’s in November 2020 and continued to advise the company for the next one year. Commenting on […]
Hyderabad: Hyderabad-based pharmaceuticals company Granules India reported a 51 per cent dip in its net profit to Rs 81 crore for the second quarter ended September 30, 2021 as against Rs 164 crore in the corresponding period of the last fiscal. The company’s net income witnessed a marginal increase of four per cent to Rs […]