
Form 483 is issued to a firm’s management at the conclusion of an inspection when an investigator has observed any…
Updated recommendations are provided for the statistical analysis of adhesion scores and results The FDA has published the draft guidance…
The US FDA had conducted audit at Claris’ manufacturing facility near Ahmedabad in May 2015 Sterile injectables company; Claris Lifesciences…
The US FDA had conducted audits at Lupin’s Mandideep facility from February 8-19, 2016 and its Aurangabad facility from January…
The approval confirms the closure of inspection conducted in July 2015
The ongoing recall was initiated on March 30, 2016
As game changes, companies need to redraw long-term strategies and focus on innovation
To acquire Anacor Pharmaceuticals for $5.2 billion Pfizer and Anacor Pharmaceuticals have entered into a definitive merger agreement under which…
The product is expected to be launched in the second quarter of 2016-17 fiscal, it added
Concerned with declining pharma exports in the recent past, the Ministry of Commerce & Industry has tried to burnish the…
Sri Krishna Pharmaceuticals, a supplier of paracetamol and other drugs to more than 60 countries, has been warned by the…
The company, however, did not provide any details about the observations
According to a report in Centrum Broking, the domestic pharma market will gain from price increase, volume growth and new…
First NSAID approved for prevention of ocular pain in patients undergoing cataract surgery
The self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart The US Food and Drug…
It is Glenmark’s first injectable approval in the US
The plant has a capacity to manufacture 2.2 billion tablets, 32 million bottles of liquid orals, 16 million tubes of…
Neelikon has emerged as a prime manufacturer of high quality colourants for food colour, pharmaceutical colours, cosmetic colours, personal care…
The combined company will have a portfolio of over 120 in-market products, over 185 cumulative filings pending approval and a…
Ajanta Pharma USA is scheduled to launch the almotriptan malate tablets in the US shortly Ajanta Pharma has received final…
The formulations manufacturing facility at Baddi will produce the drug for the US market
The product is likely to be launched in Q1 FY16-17
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