US FDA
भारत बायोटेक के कोवैक्सीन को अमेरिका में इमरजेंसी अप्रूवल नहीं, FDA ने खारिज किया एप्लीकेशन
एफडीए ने इस टीके के लिए अमेरिका में भारत बायोटेक की पार्टनर Ocugenको बायोलोजिक्स लाइसेंस
FDA publishes draft guidance on assessing adhesion with TDS and topical patches for ANDAs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recommendations are provided for the statistical analysis of adhesion scores and results The FDA has published the draft guidance for industry entitled, ‘Assessing Adhesion with Transdermal Delivery Systems and
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 Lifesciences has announced that it has received the Establishment Inspection Report (EIR) for i
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 11-15, 2016 Lupin has announced that it has received Establishment Inspection Reports (EIR) for
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 agreement under which Pfizer will acquire Anacor for $99.25 per Anacor share, in cash, for a total tra
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 image of India's pharmaceutical sector
US FDA warns Sri Krishna Pharma, citing drug-data manipulation
Sri Krishna Pharmaceuticals, a supplier of paracetamol and other drugs to more than 60 countries, has been warned by the US Food and Drug Administration (FDA), which cited manipulation of its test results at a plant.
