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...
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...
Indoco Remedies gets USFDA warning letter for significant violations at Goa facility Medical Dialogues Bureau26 July 2019 9:30 AM ISTStating the specific violations, the US Food and Drug Administration (USFDA) said Indoco Remedies failed to prepare batch production and control...
Allergan announces worldwide recall of textured breast implant tied to rare cancer Medical Dialogues Bureau26 July 2019 9:15 AM ISTThe U.S. Food and Drug Administration said it called for the removal after new information showed Allergan Inc's Biocell breast implants account for 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...
Sanofi strikes deal for US rights to Roche Tamiflu Medical Dialogues Bureau24 July 2019 9:15 AM ISTUnder the terms of the agreement, Sanofi will be responsible for leading FDA negotiations for the OTC switch and subsequent exclusive marketing,...
Laurus Labs, Rising Pharma launches neuropathic pain capsules in US Medical Dialogues Bureau23 July 2019 9:30 AM ISTRising Pharmaceuticals has launched a generic version of Lyrica capsules, in the strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and...
Zydus Cadila arm gets USFDA nod for generic version of Adderall XR capsules in US Medical Dialogues Bureau21 July 2019 10:00 AM ISTThe product is a generic version of Adderall XR capsules and will be manufactured at Nesher Pharmaceuticals' manufacturing facility at St Louis in the...
USFDA to review Sanofi isatuximab for treatment of multiple myeloma Medical Dialogues Bureau21 July 2019 9:15 AM ISTSanofi Isatuximab targets a specific epitope on the CD38 receptor. It is designed to trigger multiple, distinct mechanisms of action that are believed...
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,...
USFDA completes inspection at Laurus Labs' AP unit Medical Dialogues Bureau19 July 2019 10:02 AM ISTMumbai: Laurus labs recently announced that they have completed the US Food and Drug Administration (USFDA) inspection of Unit 4 at Visakhapatnam,...
