Industry News

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.

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Triazolam Tablets USP, 0.125 mg and 0.25 mg.

Triazolam tablets are used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep). It works by slowing activity in the brain to allow sleep. The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India.

Dr Reddy's Lab said today that all the litigation claims against the company over Revlimid have been dismissed in the USA court.

In Nov 2022, Antitrust case filed against Dr Reddys Labs in the US over maintaining a shared monopoly in the sale of brand and generic Revlimid through their respective settlements of patent litigation with other pharmaceutical companies.

Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the finalization of a strategic partnership with the UK government to establish a state-of-the-art mRNA research, development, and manufacturing facility in the UK. This milestone follows the agreement in principle between Moderna and the UK government, announced in June 2022.