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1627 News Found

Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP
News | August 06, 2024

Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP

Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity


Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets
Drug Approval | August 01, 2024

Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries


Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Drug Approval | July 30, 2024

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance


Dr Reddys Laboratories posts Q1 FY25 consolidated PAT at Rs. 1,392 Cr
News | July 29, 2024

Dr Reddys Laboratories posts Q1 FY25 consolidated PAT at Rs. 1,392 Cr

Dr. Reddy's Laboratories has reported total income of Rs. 7,672.7 crores during the period ended June 30, 2024


Briefs: Indoco Remedies and Alembic Pharmaceuticals
Drug Approval | July 29, 2024

Briefs: Indoco Remedies and Alembic Pharmaceuticals

Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe


Zydus receives USFDA’s final approval for Valsartan Tablets
Drug Approval | July 24, 2024

Zydus receives USFDA’s final approval for Valsartan Tablets

The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India


Syngene reports drop in Q1 FY25 revenue to Rs. 790 Cr
News | July 24, 2024

Syngene reports drop in Q1 FY25 revenue to Rs. 790 Cr

Reported profit after tax declined 19% year-on-year to Rs 76 crores


USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau
Drug Approval | July 24, 2024

USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau

The inspections concluded with no Form 483 observations or significant critical findings


Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval
Drug Approval | July 22, 2024

Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval

Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well