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1473 News Found

Granules India’s Unit V facility secures USFDA EIR with NAI status
Drug Approval | November 10, 2024

Granules India’s Unit V facility secures USFDA EIR with NAI status

The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit


Vimta Labs reports Q2 FY25 PAT at Rs. 17 Cr
News | November 10, 2024

Vimta Labs reports Q2 FY25 PAT at Rs. 17 Cr

Q2 FY25 Total Income was at Rs. 85.4 crore


Lupin receives tentative approval from USFDA for Raltegravir Tablets
Drug Approval | November 09, 2024

Lupin receives tentative approval from USFDA for Raltegravir Tablets

This product will be manufactured at Lupin’s Nagpur facility in India


Briefs: Sun Pharmaceutical Industries and Biocon Biologics
News | November 04, 2024

Briefs: Sun Pharmaceutical Industries and Biocon Biologics

The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI


Zydus receives acceptability from WHO for Typhoid Vi Conjugate Vaccine ZyVac TCV
Drug Approval | October 23, 2024

Zydus receives acceptability from WHO for Typhoid Vi Conjugate Vaccine ZyVac TCV

Company receives acceptability, in principle, for ZyVac TCV making it eligible for purchase by United Nations procurement agencies


Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules
Drug Approval | October 21, 2024

Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules

Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension


Zydus receives final approval from USFDA for Fludrocortisone Acetate Tablets USP, 0.1 mg
Drug Approval | October 19, 2024

Zydus receives final approval from USFDA for Fludrocortisone Acetate Tablets USP, 0.1 mg

Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad


Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets
Drug Approval | October 19, 2024

Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets

Granules now has a total of 67 ANDA approvals from the USFDA


FDA approves VYALEV for adults living with advanced parkinson's disease
Drug Approval | October 18, 2024

FDA approves VYALEV for adults living with advanced parkinson's disease

VYALEV is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease


Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3
Drug Approval | October 14, 2024

Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3

Indoco is comprehensively working on the remedial action plan