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Tag: usfda inspection

You Searched For "usfda inspection"
Indoco Remedies CRO AnaCipher gets one Form 483 from USFDA

Indoco Remedies CRO AnaCipher gets one Form 483 from USFDA

Ruchika Sharma10 March 2025 5:50 PM IST
Mumbai: Indoco Remedies Limited announced that its Clinical Research Organisation, AnaCipher, located at Hyderabad has received one Form 483 from the...
Indore pharma unit under fire as inspection flags 216 lapses

USFDA successfully completes audit at JB Chemicals and Pharma Gujarat facility

Ruchika Sharma10 March 2025 11:15 AM IST
Mumbai: J.B. Chemicals & Pharmaceuticals Limited has announced that the US Food and Drug Administration (USFDA) has successfully completed an...
Biocon gets 1 USFDA observation for Cranbury site

Alembic Pharma gets one procedural observation for Vadodara facility

Ruchika Sharma7 March 2025 5:43 PM IST
Vadodara: Alembic Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded an inspection with...
Biocon gets 1 USFDA observation for Cranbury site

Unichem Labs Pithampur API facility gets 4 USFDA observations

Ruchika Sharma3 March 2025 11:30 AM IST
Mumbai: Unichem Labs has announced that the United States Food and Drug Administration (USFDA) has concluded an inspection with four observations...
After Manipal Hospitals, PMC warns all private hospitals against withholding dead bodies over unpaid bills

USFDA issues warning letter to Granules India Gagillapur facility

Ruchika Sharma27 Feb 2025 5:41 PM IST
Telangana: Granules India has announced that the US Food and Drug Administration (US FDA) has issued a Warning Letter to the Company's Gagillapur...
Emcure Pharma Gets CDSCO Panel Nod to Conduct Phase IV Trial on Drospirenone Tablets

Emcure Pharma Pune facility gets 2 USFDA observations

Ruchika Sharma26 Feb 2025 3:14 PM IST
Pune: Emcure Pharmaceuticals Limited has announced that the Company has received two observations in Form 483 from the United States Food and...
Dr. Reddys Labs Gets CDSCO Panel Nod to Manufacture, Market   Semaglutide Injection

USFDA issues EIR for Dr Reddy's Labs Hyderabad facility

Ruchika Sharma26 Feb 2025 2:30 PM IST
Hyderabad: Dr Reddy's Labs has announced that the Company has received the Establishment Inspection Report (EIR) from the United States Food...
Gland Pharma Pashamylaram facility receives GMP compliance certificate from Danish Medicines Agency

Gland Pharma gets 3 USFDA observations for Visakhapatnam facility

Ruchika Sharma26 Feb 2025 11:30 AM IST
Hyderabad: Gland Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded an inspection with three observations...
Syngene International plans to add bioconjugation suite for end-to-end Antibody-Drug conjugates development

Syngene International gets 5 USFDA observations for Bengaluru facilities

Ruchika Sharma24 Feb 2025 11:30 AM IST
Bengaluru: Syngene International has announced that the U.S. Food and Drugs Administration (USFDA) has concluded the inspection with five...
Lupin rolls out Loteprednol Etabonate Ophthalmic Suspension in US

USFDA issues EIR for Lupin Somerset facility

Ruchika Sharma22 Feb 2025 11:30 AM IST
Mumbai: Global pharma major Lupin Limited has announced that the United States Food and Drug Administration (U.S. FDA) has issued the...
USFDA issues 2 observattions for Cipla arm Mahape facility

USFDA issues 2 observations for Cipla arm Mahape facility

Ruchika Sharma21 Feb 2025 1:30 PM IST
Mumbai: Cipla, an Indian multinational pharmaceutical company, has announced that the United States Food and Drugs Administration...
USFDA Raises Compliance Concerns at Hetero Labs Nakkapalli Facility

USFDA issues 7 minor observations for Orchid Pharma Alathur facility

Ruchika Sharma20 Feb 2025 2:30 PM IST
New Delhi: Orchid Pharma Ltd., a vertically integrated pharmaceutical company, has received seven minor observations from the U.S. Food and...
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