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  • usfda inspection

Tag: usfda inspection

You Searched For "usfda inspection"
USFDA concludes inspection at Shilpa Medicare Raichur unit

Shilpa Medicare gets USFDA VAI status for Hyderabad unit

Ruchika Sharma22 May 2023 2:43 PM IST
Karnataka: Shilpa Medicare has announced that the US FDA GMP inspection performed on Company’s Analytical Services Division situated on first...
USFDA successfully concludes inspection at Piramal Pharma Pithampur facility

USFDA successfully concludes inspection at Piramal Pharma Pithampur facility

Ruchika Sharma22 May 2023 12:43 PM IST
Mumbai: Piramal Pharma Limited has announced that the US Food and Drug Administration (USFDA) has successfully concluded an inspection at the...
Phase 3 study comparing Yesintek with Stelara in adult patients with chronic plaque psoriasis shows positive results: Biocon Biologics

Biocon gets zero UFSDA observations for Hyderabad facility

Ruchika Sharma22 May 2023 12:12 PM IST
Bangalore: Biocon has announced that the US Food and Drug Administration (USFDA) has completed a pre-approval inspection at the...
Aurobindo Pharma arm CuraTeQ Biologics completes successful Phase 1 Pharmacokinetics study of bone drug

Aurobindo Pharma Anakapalli facility gets 4 USFDA observations

Ruchika Sharma20 May 2023 12:31 PM IST
Hyderabad: Aurobindo Pharma has announced that the company has received four observations from the United States Food and Drug Administration (US FDA)...
Strides Pharma Science Acetaminophen and Ibuprofen Tablets

Strides Pharma Science gets USFDA EIR for Puducherry facility

Ruchika Sharma19 May 2023 12:24 PM IST
Bengaluru: Strides Pharma Science Limited has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA)...
Marksans Pharma arm New York facility gets 1 USFDA observation

Dr Reddy's Labs gets 4 USFDA observations for Srikakulam facility

Ruchika Sharma13 May 2023 2:16 PM IST
Hyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) today completed a product-specific...
Zydus Lifesciences Moraiya facility gets EIR from USFDA

Zydus Lifesciences Moraiya facility gets EIR from USFDA

Ruchika Sharma11 May 2023 11:35 AM IST
The inspection was a PAI for Transdermal Patch products
Alembic Pharma commissions new manufacturing facility in Pithampur to expand business

Alembic Pharma gets USFDA EIR for Jarod facility

Ruchika Sharma10 May 2023 11:32 AM IST
Vadodara: Pharma major, Alembic Pharmaceuticals, has announced that the Company has received Establishment Inspection Report (EIR) from US Food...
Dr Reddys Labs gets one USFDA observation for Hyderabad facility

Dr Reddys Labs gets one USFDA observation for Hyderabad facility

Ruchika Sharma6 May 2023 12:30 PM IST
Hyderabad: Pharma major, Dr Reddy's Labs, has recently announced that the United States Food & Drug Administration (USFDA) has issued a Form 483...
Indoco Remedies CRO AnaCipher gets one Form 483 from USFDA

USFDA issues EIR for Indoco Remedies Goa facility

Ruchika Sharma3 May 2023 3:55 PM IST
Mumbai: Indoco Remedies Ltd. announced today the receipt of an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) status...
Cipla arm gets zero Form 483 observations from USFDA for USA facility

Cipla arm gets zero Form 483 observations from USFDA for USA facility

Ruchika Sharma3 May 2023 12:30 PM IST
Mumbai: Cipla has recently announced that the US Food and Drug Administration has concluded inspection with zero Form 483 observations at the Fall...
Aurobindo Pharma arm gets USFDA EIR for Telangana unit

Ipca Labs gets 3 USFDA observations for Piparia facility

Ruchika Sharma27 April 2023 11:15 AM IST
Mumbai: Ipca Laboratories has recently announced that the US Food and Drug Administration (USFDA) has issued a Form 483 with 3 observations at the...
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