Glenmark Pharma receives tentative ANDA approval for solifenacin succinate tabs
According to IMS Health, the Vesicare tablets, 5 mg and 10 mg market achieved annual sales of approximately $1.1 billion
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Browsing Tag
US FDA
FDA publishes draft guidance on assessing adhesion with TDS and topical patches for ANDAs
Updated recommendations are provided for the statistical analysis of adhesion scores and results
The FDA has published the draft…
Claris announces receipt of EIR from US FDA
The US FDA had conducted audit at Claris’ manufacturing facility near Ahmedabad in May 2015
Sterile injectables company; Claris…
Lupin announces closure of US FDA audits for its Mandideep and Aurangabad facilities
The US FDA had conducted audits at Lupin’s Mandideep facility from February 8-19, 2016 and its Aurangabad facility from January…
Indoco Remedies receives US FDA nod for Goa manufacturing facility
The approval confirms the closure of inspection conducted in July 2015
Dr Reddy’s recalls 50k bottles of Ondansetron tabs in US
The ongoing recall was initiated on March 30, 2016
Pharma exports growth heading for a sharp decline: CRISIL Research
As game changes, companies need to redraw long-term strategies and focus on innovation
Pfizer signs definitive merger agreement with Anacor Pharmaceuticals
To acquire Anacor Pharmaceuticals for $5.2 billion
Pfizer and Anacor Pharmaceuticals have entered into a definitive merger…
Aurobindo Pharma gets US FDA nod for anaesthetic injection
The product is expected to be launched in the second quarter of 2016-17 fiscal, it added
Embracing quality as an opportunity
Concerned with declining pharma exports in the recent past, the Ministry of Commerce & Industry has tried to burnish the brand…