CDSCO apprises about the Continuity in validity of Written Confirmation Certificate for API consignments for Exports Farhat Nasim15 Sept 2019 10:36 AM ISTNew Delhi: Through a recent circular, the Central Drugs Standard Control Organisation (CDSCO) has apprised about maintaining the continuity in the...
Unichem Labs receives zero USFDA observations for Roha facility Medical Dialogues Bureau15 Sept 2019 10:00 AM ISTThe inspection of the active pharmaceutical ingredients facility at Roha was conducted from September 9 to September 12 2019 by the United States Food...
GSK gets USFDA nod for Nucala, only biologic to treat eosinophilic asthma in age group 6-11 year Medical Dialogues Bureau15 Sept 2019 9:50 AM ISTNucala is the only targeted biologic to be approved for the condition in the six to 11-year age group in the US, said GSK.New Delhi: GlaxoSmithKline...
Granules India gets EIR from USFDA for Paracetamol, Metformin API manufacturing plant Medical Dialogues Bureau15 Sept 2019 9:30 AM ISTBonthapally facility is one of the world’s largest single-site Paracetamol API manufacturing plant by volume. Along with Paracetamol APIs, the...
One Drug, Multiple Manufacturing Facilities: CDSCO approves manufacturing of new drug in additional sites Farhat Nasim14 Sept 2019 4:38 PM ISTNew Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has apprised drug makers that they can manufacture a new...
UK drug regulator MHRA reinstates full GMP status to Indoco Goa Plant I Medical Dialogues Bureau14 Sept 2019 11:52 AM ISTUK-MHRA conducted a ‘Focused Audit’ in October 2018 and GMP audit in May 2019. These audits were completed with no Critical Observations and Indoco...
Lupin: FIRST to win Canadian approval for generic version of Inderal-LA capsules Farhat Nasim14 Sept 2019 9:45 AM ISTLupin is the first generic company to receive approval for generic Inderal-LA capsules for the Canadian market and the product will be manufactured at...
Pharmexcil DG Uday Bhasker sees Indian pharma exports at USD 22 billion in fiscal 2019-20 Medical Dialogues Bureau14 Sept 2019 9:16 AM ISTDirector-general of Pharmexcil, a body under the Ministry of Commerce and Industry, Uday Bhasker said some of the policy decisions being taken by the...
Bayer, Monsanto India mega-merger worth USD 63 billion gets clearance from NCLT Medical Dialogues Bureau14 Sept 2019 9:15 AM ISTBayer CropScience took shareholders' approval for the merger during the first quarter of 2019-20 and was waiting for the final approval of the NCLT to...
Carcinogen in popular heartburn drug Zantac triggers safety review by European, US regulators Medical Dialogues Bureau14 Sept 2019 9:15 AM ISTValisure said in its report that it found the impurity in both Sanofi SA's branded Zantac as well as generic versions of the drug. But the FDA would...
Biocon inks license, supply pact with CMS for 3 generic formulations Medical Dialogues Bureau13 Sept 2019 2:45 PM ISTUnder the terms of the agreement, Biocon will be responsible for the development, manufacturing and supply of the products and China Medical System...
Dr Reddys gets EIR from USFDA for manufacturing plants at Duvvada Medical Dialogues Bureau13 Sept 2019 11:59 AM ISTThe company has received EIR from the United States Food and Drug Administration (USFDA) for the inspection conducted at the formulations...
