CDSCO Panel grants Intas Package Insert update for Pegfilgrastim solution for injection 6mg/0.6mL vial and PFS Dr. Divya Colin5 Feb 2024 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Center Drug Standard Control Organisation (CDSCO) has approved drug major Intas...
Intas Pharma Gets CDSCO Panel Nod to Study anti-cancer Drug Lipid Based Cabazitaxel Dr. Divya Colin1 Feb 2024 6:00 PM ISTNew Delhi: Citing that the firm should include an adequate number of government hospital trial sites, the Subject Expert Committee (SEC) functional...
CDSCO Panel grants Intas Pharma's proposal for additional pack of Romiplostim Injection 125 mcg/vial Dr. Divya Colin16 Jan 2024 5:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Intas Pharma gets exclusive rights to commercialize Etanercept biosimilars in more than 150 countries across globe Ruchika Sharma25 Dec 2023 11:30 AM ISTAhmedabad: Intas Pharmaceuticals Ltd., a multinational pharmaceutical company, has announced a strategic exclusive licensing agreement with...
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...
