Alembic Pharmaceuticals receives USFDA approvals for 5 products in Q1FY24

Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.

Venus Remedies receives approval to market meropenm in Spain

The company expects to capture a 10 per cent share in Spain’s $6.34 million meropenem market and consolidate its position in other European countries

Lupin receives USFDA approval for Tiotropium Dry Powder Inhaler

This product will be manufactured at Lupin's Pithampur facility in India

Zydus receives final approval from the USFDA for Minocycline Hydrochloride ER Tablets

The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.

Biostar Pharma receives FDA approval Utidelone Injectable Phase 2/3 clinical trial for cell lung cancer

This trial is a multi-national, phase 2/3, open-label, randomized, controlled clinical study of utidelone injectable

Granules India receives ANDA approval for Levetiracetam Tablets

Granules now has a total of 58 ANDA approvals from US FDA

Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets

Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States

Granules India received ANDA approval for Metoprolol Succinate ER Tablets

Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.

Milla receives first cycle FDA approval for Dexmedetomidine Hydrochloride Injection

Zydus receives final approval from USFDA for Esomeprazole Magnesium

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)