Press Releases

Press Release - Aurobindo Pharma receives USFDA Final Approval for Perampanel Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mgAurobindo Pharma Limited is pleased to announce the receipt of final approval from the US Food & Drug Administration (USFDA) to manufacture and market Perampanel Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg, which are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Fycompa® Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg, of Catalyst Pharmaceuticals, Inc.

Press Release - Acrotech Biopharma Launches ADQUEY in the U.S. and Establishes Dedicated Dermatology Business Novel, non-steroidal topical PDE4 inhibitor is approved for adults and pediatric patients aged 2 years and older

Press Release - Aurobindo Pharma receives USFDA Final Approval for Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcgAurobindo Pharma Limited today announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcg, a generic equivalent of QVAR® Inhalation Aerosol 40 mcg and 80 mcg, marketed by Teva Branded Pharmaceutical Products R&D LLC.

Press Release - Lannett Company LLC announces launch of generic version of Advair Diskus in the USWe are pleased to inform you that Lannett Company LLC, a wholly owned subsidiary of Aurobindo Pharma USA, Inc., has launched the generic equivalent of Advair Diskus® (fluticasone propionate and salmeterol inhalation powder), a product of GSK plc, in 100/50 mcg and 250/50 mcg strengths, in the US market.

Press Release - Aurobindo Pharma signs non-exclusive voluntary license agreement with MSDRio de Janeiro, Brazil — Aurobindo Pharma Limited is pleased to announce that it has entered into a non-exclusive voluntary licensing agreement with MSD (trade name of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK). Aurobindo Pharma is among a select group of global generic manufacturers to have signed this agreement.

Press Release - Aurobindo Pharma USA Receives FTC Approval to Acquire Lannett CompanyAurobindo Pharma USA, Inc. (“Aurobindo USA”), a wholly owned subsidiary of the Company, today announced that it has received approval from the U.S. Federal Trade Commission (FTC) to proceed with the acquisition of Lannett Company LLC (“Lannett”).

Press Release - Aurobindo Pharma Inaugurates TheraNym - Pioneering Indias Large-Scale Biologics Contract Manufacturing FacilityIn the presence of Shri D. Sridhar Babu and Shri Damodar Raja Narasimha, Ministers of the Government of Telangana, Aurobindo Pharma unveiled a landmark CMO that sets a new standard for biologics manufacturing in India - with MSD joining as its anchor customer.

Press Release - Aurobindo Pharma receives USFDA approval for Dextromethorphan Polistirex Extended-Release Oral Suspension, 30 mg5 mL OTC Aurobindo Pharma Limited is pleased to announce the receipt of the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Aurobindo Pharma receives USFDA Approval for Dextromethorphan Polistirex Extended-Release Oral Suspension, 30 mg/5 mL (OTC), which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Delsym Extended-Release Oral Suspension, 30 mg/5 mL, of RB Health (US) LLC.

Press Release - Aurobindo Pharma receives USFDA approval for Glycerol Phenylbutyrate Oral Liquid,1.1 grams per mLAurobindo Pharma Limited is pleased to announce the receipt of the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Ravicti Oral Liquid 1.1 grams per mL, of Horizon Therapeutics U.S. Holding LLC.

Press Release - Aurobindo Pharma receives USFDA approval for Dapagliflozin and Metformin Hydrochloride Extended-Release TabletsAurobindo Pharma Limited is pleased to announce that the final approval is received from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/ 500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg,

Press Release - Aurobindo Pharma receives USFDA approval for Dapagliflozin Tablets, 5 mg and 10 mgAurobindo Pharma Limited is pleased to announce that the final approval is received from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin Tablets, 5 mg and 10 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB.

Press Release - Aurobindo Pharma receives USFDA approval for Dapagliflozin Tablets, 5 mg and 10 mgAurobindo Pharma Limited is pleased to announce that the final approval is received from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin Tablets, 5 mg and 10 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB.

Press Release - CuraTeQ Biologics Announces Positive Top-Line Results for Phase 3 Study of Omalizumab Biosimilar BP11CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd and a biopharmaceutical company developing biosimilars, today announced positive top-line results from its Phase 3 study of BP11, an investigational biosimilar to Xolair® (omalizumab).

Press Release - Eugia Pharma announces launch of Pomalidomide Capsules in the USWe enclose a copy of the Press Release that is being issued by the Company in connection with launch of Pomalidomide Capsules, 1 mg, 2 mg, 3 mg and 4 mg, in the US market by Eugia Pharma Specialities Limited, a wholly owned subsidiary of the Company.

Press Release - Eugia Pharma receives USFDA Approval for Everolimus TabletsWe enclose a copy of the Press Release that is being issued by the Company in connection with USFDA approval received by Eugia Pharma Specialities Limited, a wholly owned subsidiary of the Company, for Everolimus Tablets, 0.25 mg, 0.5 mg, 0.75 mg and 1 mg.

Acrotech Biopharma Inc. Announces FDA Approval of ADQUEYTM difamilast 1 Ointment for the Treatment of Mild-to-Moderate Atopic DermatitisWe are pleased to inform that Acrotech Biopharma Inc (“Acrotech”) a step-down subsidiary of Aurobindo Pharma Ltd, in collaboration with Otsuka Pharmaceutical Co., Ltd., today announced that the U.S. Food and Drug Administration (FDA) granted approval for its New Drug Application (NDA) for ADQUEY™ (difamilast 1%) ointment, for the topical treatment of mild-to-moderate atopic dermatitis (AD) in adults and paediatric patients aged 2 and older.