Shilpa Medicare gets 5 USFDA observations for Raichur facility Medical Dialogues Bureau31 July 2019 9:30 AM IST"We have received Form 483 with five observations, with no repeat observations and any data integrity observations. The observations are mostly...
Novartis Expiry of Patent for Blockbuster Vildagliptin to Clear Way for Competitors Farhat Nasim30 July 2019 2:08 PM ISTNew Delhi: The patent protection of blockbuster anti-diabetic drug Vildagliptin manufactured by the Swiss drugmaker, Novartis, will soon expire on...
Granules India completes USFDA inspection for Bonthapally facility with one observation Farhat Nasim29 July 2019 10:00 AM ISTGranules India Ltd's Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plant by volume. New Delhi: Drug...
Jubilant Life Sciences net profit slips 7.68 percent to Rs 185 crore for June quarter Farhat Nasim29 July 2019 9:00 AM IST"We have had a steady performance during the quarter. Pharmaceutical segment revenues have been higher by 12 per cent YoY led by growth in CMO,...
DOP junks Geltec plea against NPPA decision on retail price of Ibuprofen Soft Gelatin Capsules Farhat Nasim28 July 2019 11:30 AM ISTNew Delhi: Through a recent decision, the Department of Pharmaceuticals (DOP) has rejected the review application filed by Geltec Private Limited...
Indoco Remedies receives EIR from USFDA for sterile, solid dosages facility in Goa Medical Dialogues Bureau27 July 2019 9:45 AM ISTThe inspection was held from May 27-June 4, 2019 and the company received four Form 483 observations, Indoco Remedies said in a filing to BSE.NEW...
Biocon appoints Mayank Verma as Company Secretary, Compliance Officer Farhat Nasim27 July 2019 9:00 AM ISTPrior to joining the Biocon Group, Mayank Verma has worked with ING Vysya Bank Limited from 2007 to 2012.New Delhi: Biotechnology major, Biocon has...
Apixaban Patent: Natco gets HC relief for its upcoming medicine Apigat Farhat Nasim26 July 2019 3:00 PM ISTNEW DELHI: Days after ending a patent row over its cancer drug Regonat with Bayer, drugmaker, Natco Pharma is reported to have now been embroiled in a...
Zydus Cadila launches Ramelteon tablets in US to treat insomnia Medical Dialogues Bureau25 July 2019 11:23 AM ISTIn a BSE filing, Zydus Cadila announced the "launch of Ramelteon tablets, 8 mg upon receiving the final approval from the USFDA. Ramelteon is a...
NPPA notices worth Rs 101 crore sent to Biocon, Lupin, Dr Reddys, others for skipping regulatory nod-Minister Medical Dialogues Bureau24 July 2019 12:16 PM ISTNPPA has so far issued demand notices for an amount of Rs 101 crore against defaulting companies. Out of this, an amount of Rs 5.56 crore has been...
Strides Pharma found destroying, dumping drug production documents: USFDA Investigation Medical Dialogues Bureau20 July 2019 2:16 PM ISTIn the letter to Strides Pharma, the FDA didn't explain whether its inspectors often check scrap yards or shredding rooms for documents, or whether it...
Dr Reddys unveils generic version of Allegra D in US to treat common cold, flu Medical Dialogues Bureau20 July 2019 11:37 AM ISTIn a BSE filing, Dr Reddy's Labs(Dr Reddys) announced "launch of Fexofenadine HCI 60 mg and Pseudoephedrine HCI 120 mg extended-release tablets, USP,...
