Case Study – Quick Look up at DCGI approval of Lundbeck’s Brintellix
Posted on15 Oct 2018
TagsBrintellix, CDSCO, codevelopment deal in pharma, comarketing deal in pharma, copromotion deal in pharma, DCGI, Lundbeck, vortioxetine
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Lundbeck India Private Limited (LIPL) announces the launch of Brintellix (vortioxetine) in India for the treatment of patients suffering from major depressive... Read More
Indian health ministry banned 329 controversial fixed dose combination with immediate effect
The ministry of health and family welfare has prohibited the manufacture for sale, sale or distribution for human use of 329 fixed... Read More
AstraZeneca’s Lynpraza got DCGI (India) marketing approval
AstraZeneca Pharma India has received Import & Market permission for olaparib (Lynparza )100 mg and 150 mg tablets in India by the... Read More
Drug Approval Case Study: Marketing of non-approved FDCs in India and DCGI’s FDC approval process request
Recently, the Drug Controller General of India (DCGI) found that 3 Indian drug makers are selling a combination drug to treat hypertension... Read More
Case Study: DCGI ordered the withdrawal of Voveran of Novartis
Posted on12 Jul 2018
TagsDCGI, diclofenac painkiller injection, Dynapar AQ, Product Recall, product withdrawal, themis, Transcutol-P, Voveran
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India’s drug regulator has ordered the withdrawal of the popular diclofenac painkiller injection marketed by Novartis India Ltd and made by Themis... Read More
A close look into AstraZeneca’s DCGI marketing approval for Symbicort 320 for asthma and COPD
What is meant by DCGI approval? Drug Controller General of India (DCGI) under the Central Drugs Standard Control Organization is responsible for... Read More