Intas Pharma gets USFDA warning letter due to manufacturing lapses at Ahmedabad plant Ruchika Sharma11 Dec 2023 11:30 AM IST"Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," USFDA said.
CDSCO Drug Alert: 61 Drug Samples Including Emcure's Levocarnitine Inj Flagged Dr. Divya Colin24 Nov 2023 6:00 PM ISTNew Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 61 medicine...
Intas Pharma to commercialise Serplulimab in India Ruchika Sharma30 Oct 2023 3:29 PM ISTSerplulimab will be commercialised by Intas in India and by its subsidiary, Accord Healthcare Ltd, in Europe.
CDSCO Drug Alert: 48 Drug Samples Flagged Susmita Roy26 Sept 2023 6:00 PM ISTNew Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 48 medicine...
Intas Gets CDSCO Panel Nod To Manufacture, Market Tacrolimus Liquid Tablets Dr. Divya Colin18 Aug 2023 6:00 PM ISTNew Delhi: The drug major Intas Pharmaceutical has got approval from the Subject Expert Committee ( SEC) functional under the Central Drug Standard...
Intas Pharma Sanand plant gets USFDA warning letter Ruchika Sharma7 Aug 2023 12:30 PM IST"Our investigators observed plastic bags filled with torn and discarded original CGMP documents in your quality control scrap area under a stairwell,...
Intas Pharma marketing authorization application for proposed biosimilar of Stelara accepted by EMA Ruchika Sharma15 July 2023 11:00 AM ISTDMB-3115 is a proposed biosimilar to Stelara which is a blockbuster drug developed by Janssen Biotech Inc. for plaque psoriasis, psoriatic arthritis,...
Revise CT protocol: CDSCO Panel tells Intas on antipsychotic Drug Endoxifen Dr. Divya Colin27 March 2023 6:00 PM ISTNew Delhi: Noting that the study drug Endoxifen is already approved in India since 10-12-2019 for proposed indication, the Subject Expert Committtee...
DoP rejects Intas Pharma submission against NPPA over Globucel M ceiling price Farhat Nasim28 Dec 2022 6:00 PM ISTNew Delhi: The Department of Pharmaceuticals (DoP) has rejected Intas Pharmaceuticals' plea against the National Pharmaceutical Pricing Authority...
Intas Pharma, Syna Therapeutics ink pact for commercialization of LB-0702 in Global Markets Ruchika Sharma6 Nov 2022 2:00 PM ISTAhmedabad: Syna Therapeutics, a joint venture of Reig Jofre and Leanbio, has signed a global rights licensing deal with Intas Pharmaceuticals...
CDSCO panel approves Intas pharma to continue Tofacitinib Ointment 2% CT Study Dr. Divya Colin29 Oct 2022 5:15 PM ISTNew Delhi: Citing that drug maker, Intas Pharma should report in case of any Serious Adverse Events (SAEs) related to the Phase III clinical trial of...
Anti-trust regulator CCI clears Abu Dhabi Investment Authority minority stake acquisition in Intas Pharma Ruchika Sharma11 Oct 2022 11:15 AM ISTNew Delhi: Anti-trust regulator Competition Commission of India (CCI) has cleared Platinum Owl's acquisition of a minority stake in Intas...
