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USFDA EIR
Lupin receives USFDA EIR for Goa facility with VAI statusDrug maker Lupin said it has received an Establishment Inspection Report from the US Food and Drug Administration for its Goa-based manufac...- Biocon says probe on Malaysia manufacturing unit ends“This is to inform you that Biocon Sdn Bhd, a subsidiary of Biocon, has received the EIR from the USFDA for the pre-approval inspection of ...
- Zydus Cadila gets EIR from USFDA for Ankleshwar facilityThe company's active pharmaceutical ingredient (API) manufacturing facility located at Ankleshwar (unit 1), Gujarat has received an Establi...
- Warning letter woes: Dr Reddy's expects FDA inspection of AP plant by year-endUSFDA had issued warning letter in November 2015 relating to Current Good Manufacturing Practice deviations at DR Reddy's API manufacturing...
- Lupin's Pithampur unit gets inspection closure report from USFDAPithampur Unit-3 facility is involved in the manufacture of metered dose inhalers.
- Shilpa Medicare surges 11% on getting EIR from USFDA for Raichur unitsUSFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection.
- Orchid Pharma gets EIR from USFDA for its Chennai facilityAs per the USFDA, after the completion of an inspection of a facility, an EIR is issued to a company detailing inspectional findings.
- Dr Reddy's gets EIR for Vizag plant, but inspection not closedIt, however, said the US Food and Drug Administration has not closed the inspection and the manufacturing site's status remains unchanged.
- Marksans Pharma gets EIR from USFDA for its Goa facilityAs per the USFDA, after the completion of an inspection of a facility, an EIR is issued to a company detailing inspectional findings.
- Dr Reddy's gets EIR for 2 facilitiesThe company has received EIR from USFDA for its formulations manufacturing facility at Srikakulam unit II, Dr Reddy's said in a filing to B...
- Glenmark's Ankleshwar plant gets EIR report from USFDA"The EIR is issued by the FDA only if it finds the facility to be deemed acceptable," the company said in a BSE filing.
- Strides Shasun R&D unit gets USFDA inspection closure reportUSFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determine...
- Cadila Healthcare gets EIR for Ahmedabad plant from USFDA"The company's Oral Solid Dosage drug manufacturing plant located at SEZ, Ahmedabad has received an Establishment Inspection Report (EIR) f...
- Natco Pharma gets EIR from USFDA for Kothur facilityKothur facility predominantly caters to regulated international markets. EIR is given after the completion of the inspection by the USFDA.
- Wockhardt shares down 4.5% on boursesThe company's three facilities - Chikalthana and two units at Waluj in Maharashtra - have received EIR with observations, Wockhardt said in...
- Strides Shasun receives EIR report from USFDAStrides's KRS Gardens facility manufactures oral dosage forms including tablets, capsules (both hard and soft gelatine).
- Orchid Pharma jumps over 13% on getting EIR report from USFDAUSFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determine...
- Orchid Pharma gets EIR report from USFDA on inspection closureUSFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determine...
- Orchid Pharma gets EIR report from USFDA on inspection closureOrchid Pharma has received Establishment Inspection Report (EIR) from the US health regulator on the successful inspection closure for its ...
- Sharon receives EIR report from USFDA on inspection closureSharon Bio-Medicine said it has received the establishment inspection report (EIR) from the USFDA on closure of inspection of its Dehradun ...
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