Lupin receives tentative approval from USFDA for Dolutegravir Tablets for oral suspension

Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)

Lupin receives approval from FDA for Cyanocobalamin Nasal Spray

Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)

Granules India successfully completes Two US FDA Audits in a span of 2 weeks

The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.

Industry needs to establish a self-regulatory body to maintain the quality of the pharma products, says Dr Mandaviya

Dr. Reddy's enters the trade generics business in India

Dr. Reddy's aims to roll out its trade generics across cities and towns in India

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

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

Lupin launches Thiamine Hydrochloride Injection USP in the US

Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.

Lupin receives EIR from FDA for its API manufacturing facility in Vizag

The inspection closed with the facility receiving an inspection classification of NAI