Industry News

Granules India Limited announced 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 the company, for Amphetamine Mixed Salts, 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg Extended-Release (ER) capsules. It is bioequivalent to the reference listed drug product (RLD), Adderall XR® Extended-Release capsules of Takeda Pharmaceuticals USA Inc.

Sun Pharmaceutical Industries Limited  and Concert Pharmaceuticals, Inc announced that they have executed a definitive agreement under which Sun Pharma will acquire all outstanding shares of Concert through a tender offer for an upfront payment of 8.00 USD per share of common stock in cash, or 576 USD million in equity value.

BDR Pharmaceutical launched the first generic APALUTAMIDE (Brand name APATIDE) in India to treat both Metastatic Castration Sensitive Prostrate Cancer as well as Non-Metastatic Castration resistant Prostrate Cancer. The product will be available across India and shall be of 60 mg strength and available in two packs - 60 tabs and 120 tabs. Apalutamide in combination with anti-androgen therapy will significantly improve chances for survival within Metastatic Castration Sensitive Prostrate Cancer patients.

Zydus Lifesciences Limited’s subsidiary Zydus Pharmaceuticals (USA) Inc. (Zydus) has received tentative approval from the United States Food and Drug Administration (USFDA) to market Levomilnacipran Extended-Release Capsules, 20 mg, 40 mg, 80 mg, and 120 mg (USRLD: Fetzima® Extended-Release Capsules).

Global pharma major Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, to market a generic equivalent of Juluca® Tablets, 50 mg/25 mg of ViiV Healthcare Company.

Dr. Reddy’s Laboratories Ltd announced that it has acquired the trademark rights of the breast cancer drug PRIMCYV® from Pfizer Products India Pvt Ltd for use in the Indian market.

The demand for Indian generic drugs has exploded high in China amid the massive COVID surge, with Chinese experts cautioning that fake versions of these drugs are flooding the market.

Global pharma major Lupin Limited announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, to market a generic equivalent of Toviaz® Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc. The product will be manufactured at Lupin’s facility in Goa, India.

Cipla Limited announced that its wholly-owned UK subsidiary, Cipla (EU) Limited has signed definitive agreements for equity investment of EUR 15 million in Ethris GmbH , a global leader in delivering mRNAs directly to the respiratory system including administration by inhalation.