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Tag: usfda inspection

You Searched For "usfda inspection"
USFDA inspection: Sun Pharma Halol facility listed under import alert

USFDA inspection: Sun Pharma Halol facility listed under import alert

Ruchika Sharma8 Dec 2022 4:00 PM IST
Mumbai: Pharma major, Sun Pharma, has recently announced that the US Food and Drug Administration (USFDA) has listed its Halol facility...
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

Lupin gets 8 USFDA observations for Mandideep facility

Ruchika Sharma25 Nov 2022 11:00 AM IST
Mumbai: Lupin has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection with eight observations each...
Cipla gets USFDA OAI status for Goa facility

Cipla gets USFDA OAI status for Goa facility

Ruchika Sharma24 Nov 2022 1:30 PM IST
Mumbai: Pharma major Cipla has announced that the company has received a communication from the US Food and Drug Administration (USFDA) that the...
USFDA inspection: Glenmark Pharma gets warning letter for Goa facility

USFDA inspection: Glenmark Pharma gets warning letter for Goa facility

Ruchika Sharma24 Nov 2022 12:30 PM IST
Mumbai: Drugmaker Glenmark Pharma has recently announced that the US Food and Drug Administration (USFDA) has issued a warning letter to the...
Zefylti

Aurobindo Pharma Sangareddy facility gets 10 USFDA observations

Ruchika Sharma20 Nov 2022 3:30 PM IST
Hyderabad: Drugmaker Aurobindo Pharma has recently announced that the United States Food and Drug Administration (USFDA) has concluded an inspection...
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

USFDA successfully completes inspection at Bajaj Healthcare Vadodara facility

Ruchika Sharma18 Nov 2022 1:15 PM IST
Thane: Bajaj Healthcare Limited (BHL), a manufacturer of APIs, Intermediates, and Formulations, has announced a successful competition of the...
USFDA successfully concludes inspection at Syngene Bangalore facility

USFDA successfully concludes inspection at Syngene Bangalore facility

Ruchika Sharma16 Nov 2022 3:30 PM IST
Bengaluru: Syngene International Limited has recently announced that the US Food Drug Administration (USFDA) has successfully concluded a pre-approval...
Alkem Labs gets 3 USFDA observations for St Louis facility

Alkem Labs gets 3 USFDA observations for St Louis facility

Ruchika Sharma11 Nov 2022 11:44 AM IST
Mumbai: Indian multinational pharmaceutical company, Alkem Labs, has recently announced that the company has received Form 483 with...
Sun Pharma, Philogen complete patient enrollment in Phase III trial for Soft Tissue Sarcoma

Sun Pharma Mohali facility gets USFDA OAI status

Ruchika Sharma9 Nov 2022 12:30 PM IST
Maharashtra: Pharma major Sun Pharmaceutical Industries Limited has recently announced that the Company has received a communication from the US...
Zydus Lifesciences gets USFDA EIR for Moraiya facility

Zydus Lifesciences gets USFDA EIR for Moraiya facility

Ruchika Sharma7 Nov 2022 4:00 PM IST
Ahmedabad: Global Lifesciences company, Zydus Lifesciences Ltd., today announced the receipt of an Establishment Inspection Report (EIR) from...
Lupin Tarapur facility gets USFDA warning letter

Lupin Tarapur facility gets USFDA warning letter

Ruchika Sharma3 Nov 2022 1:30 PM IST
"This warning letter summarises significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API),"...
Lupin Gets Rs 18 Crore Relief as HC Bars Arbitrary Tax Reassessment

USFDA issues 5 observations for Lupin Nagpur facility

Ruchika Sharma31 Oct 2022 11:32 AM IST
Mumbai: Lupin has recently announced that the US Food and Drug Administration has concluded a Pre-Approval Inspection (PAI) with five observations at...
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