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  • usfda inspection

Tag: usfda inspection

You Searched For "usfda inspection"
Natco Pharma gets USFDA EIR for Kothur Pharma division

Granules India arm gets 1 USFDA observation for Hyderabad facility

Ruchika Sharma1 Aug 2025 5:45 PM IST
Hyderabad: Granules India has announced that the U.S. Food and Drug Administration (USFDA) has issued one observation for the facility of...
Senores Pharma arm facility gets 3 USFDA observations

Senores Pharma arm facility gets 3 USFDA observations

Ruchika Sharma28 July 2025 4:11 PM IST
Ahmedabad: Senores Pharmaceuticals Limited has announced that the United States Food & Drug Administration (USFDA) has issued three 483...
Natco Pharma gets USFDA EIR for Kothur Pharma division

Natco Pharma Mekaguda API unit gets USFDA EIR

Ruchika Sharma24 July 2025 3:46 PM IST
Hyderabad: NATCO Pharma Limited has announced that the U.S. Food and Drug Administration (USFDA) has issued an Establishment Inspection...
Dr Reddys Labs receives positive EMA Committee opinion for proposed biosimilar of Prolia, Xgeva

Dr Reddy's Labs gets USFDA EIR for New York facility

Ruchika Sharma22 July 2025 1:30 PM IST
Hyderabad: Dr Reddy's Labs has announced that the Company has received the Establishment Inspection Report (EIR) from the United States Food &...
Dr Reddys Labs receives positive EMA Committee opinion for proposed biosimilar of Prolia, Xgeva

Dr Reddy's Labs gets 7 USFDA observations for Srikakulam facility

Ruchika Sharma19 July 2025 11:31 AM IST
Hyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) has concluded an inspection with seven...
Lupin receives USFDA observations for two Pithampur manufacturing Units

Lupin receives USFDA observations for two Pithampur manufacturing units

Ruchika Sharma18 July 2025 11:57 AM IST
Mumbai: Pharma major Lupin has received multiple observations from the U.S. Food and Drug Administration (USFDA) following inspections at two of...
Shilpa Medicare Dabaspet unit gets VAI classification from USFDA

Shilpa Medicare Dabaspet unit gets VAI classification from USFDA

Ruchika Sharma16 July 2025 12:14 PM IST
Karnataka: Shilpa Medicare Limited has received an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI)...
Natco Pharma gets USFDA EIR for Kothur Pharma division

Emcure Pharma Ahmedabad oncology facility concludes USFDA inspection with no observations

Ruchika Sharma10 July 2025 11:45 AM IST
Pune: Emcure Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded a Pre-Approval Inspection (PAI) at...
Natco Pharma gets USFDA EIR for Kothur Pharma division

USFDA issues 1 observation for Granules Pharma USA facility

Ruchika Sharma28 Jun 2025 11:16 AM IST
Hyderabad: Granules India has announced that the U.S. Food and Drug Administration (US FDA) has issued one 483 observation after a...
Shilpa Medicare Dabaspet unit gets VAI classification from USFDA

SMS Pharma successfully completes USFDA inspection at Telangana Central Laboratory Analytical Services

Ruchika Sharma26 Jun 2025 9:15 AM IST
Telangana: SMS Pharma has announced the second successful completion of the United States Food and Drug Administration (USFDA) inspection at its...
Gland Pharma Pashamylaram facility receives GMP compliance certificate from Danish Medicines Agency

Gland Pharma Visakhapatnam facility gets USFDA EIR

Ruchika Sharma24 Jun 2025 11:15 AM IST
Hyderabad: Gland Pharma, a generic injectable & ophthalmic focused pharmaceutical company, has announced that the Company has received...
Unichem Labs Roha facility gets 3 USFDA observations

Unichem Labs Roha facility gets 3 USFDA observations

Ruchika Sharma23 Jun 2025 12:19 PM IST
Mumbai: Unichem Labs has announced that the United States Food and Drug Administration (USFDA) has issued three observations after the inspection...
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