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Tag: marketing authorization

You Searched For "marketing authorization"
No Free Pass: CDSCO Mandates Registration, Import License for SEZ Drugs Sold in India

CDSCO Issues Draft Guidelines for Biosimilars for Marketing Authorization, Inviting comment From Stakeholders

Dr. Divya Colin7 May 2025 6:00 PM IST
New Delhi: Through a recent notice, the Central Drugs Standard Control Organisation (CDSCO), the Directorate General of Health Services, Government of...
USFDA concludes inspection at Shilpa Medicare Raichur unit

Shilpa Medicare Gets CDSCO Panel Nod for Novel NAFLD Drug, Advances to Marketing Approval Stage

Farhat Nasim14 Feb 2025 2:04 PM IST
Raichur: Shilpa Medicare Limited, recently announced that its Investigational New Drug (IND), Nor-Ursodeoxycholic Acid Tablets (500 mg), has received...
Not a Nice Time For Dr Reddys? DTAB, CDSCO Recommends Stringent Restrictions on Nimesulide

Dr Reddy's Laboratories Gets CDSCO Panel Nod for Marketing Approval of Siponimod Tablets

Dr. Divya Colin13 Nov 2024 5:45 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control (CDSCO) has granted marketing authorization of Dr...
Eli Lilly Gets CDSCO Panel Nod To Market Mirikizumab for  ulcerative colitis in adults

Eli Lilly Gets CDSCO Panel Nod To Market Mirikizumab for ulcerative colitis in adults

Dr. Divya Colin7 April 2024 6:00 PM IST
New Delhi: Pharmaceutical major Eli Lilly has got marketing authorization from the Subject Expert Committee (SEC) functional under the Central Drug...

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