Granules Pharmaceuticals, Inc., a wholly owned subsidiary of Granules India Limited, has received Tentative Approval (TA) from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Amphetamine Extended-Release Tablets in strengths of 5 mg, 10 mg, 15 mg,
Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited, has received Tentative Approval (TA) from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets in strengths of 3.1 mg, 6.3 mg, 9.4
Granules India Limited announced that its US step-down subsidiary, Granules Consumer Health, LLC, a wholly-owned subsidiary of Granules Pharmaceuticals, Inc., successfully completed a GMP inspection by the U.S. Food and Drug Administration (FDA) with zero observations.This was the facility’s second FDA inspection, following the March
Granules India Limited today announced that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), located in Hyderabad (FEI: 3030495702), has received U.S. Food and Drug Administration (FDA) approval for a product that was the subject of a Pre- Approval Inspection (PAI) conducted between
- New Centre to Drive Green Technologies in Drug Product ManufacturingGranules India Limited, in partnership with the National Institute of Pharmaceutical Education and Research (NIPER), S.A.S Nagar, today inaugurated the Dr. Chigurupati Centre of Excellence in Innovative and Sustainable Pharmaceutical Development (CCE-ISPD).This Granules’ CSR
Granules India Limited (BSE: 532482, NSE: GRANULES), a vertically integrated pharmaceutical company committed to sustainable and responsible healthcare, has been awarded a Gold rating by EcoVadis in its inaugural corporate-level assessment. This places the company in the 97th percentile, among the top 5% of all
Granules India Limited (BSE: 532482, NSE: GRANULES) today announced the successful closing of the acquisition of Senn Chemicals AG, a Swiss- based Contract Development and Manufacturing Organization (CDMO) specializing in peptide development and manufacturing. This marks a strategic milestone in Granules’ transformation into a science-
Granules India Limited, a vertically integrated Indian pharmaceutical company, announced today that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate Capsules in strengths
Granules India Ltd., a vertically integrated pharmaceutical company, today announced its financial results for the quarter ended December 31, 2024. Financial Summary (All numbers in INR Mn., except Margins) QUARTERLY CONSOLIDATED FINANCIALS Q3FY25 Q2FY25 Growth (QoQ) Q3FY24 Growth (YoY)Revenue from Operations 11,377 9,666 18% 11,556 -2%EBITDA 2,303 2,033 13% 2,505 -8%EBITDA % 20% 21% 22% PAT 1,176 972 21% 1,257 -6%PAT % 10% 10% 11% Financial and Business Summary for Q3FY25The Company voluntarily paused
Mumbai, December 17, 2024 – Granules India Limited, a vertically integrated Indian pharmaceutical company, announced today that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine
