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USFDA AUDIT
Aurobindo Pharma receives warning from SEBI for non-disclosures related to USFDA auditThe market regulator, in its letter to Aurobindo Pharma dated June 24, said the company had disclosed very limited and restricted informati...- Aurobindo Pharma receives Sebi's warning letter over ongoing USFDA auditThe Sebi letter sent to the company on June 24, 2022 pertains to disclosures made by APL related to Official Action Indicated (OAI) and war...
- Aurobindo Pharma receives Sebi's warning letter over ongoing USFDA auditThe letter is in regards to certain disclosures made by the company on the ongoing USFDA audit of company's Unit-1 and observations made by...
- USFDA issues 3 minor observations to Granules India arm in pre-approval inspectionCommenting on the audit, GPI Executive Director Priyanka Chigurupati said, "We are glad to have completed yet another audit with minor obse...
- Cadila Healthcare gets EIR from USFDA for its Ahmedabad facilityThe company's topical manufacturing facility at Ahmedabad has received an EIR from the United States Food and Drug Administration (USFDA) s...
- Audit of Laurus Labs completed by USFDA without objectionsThe maiden United States Food and Drug Administration (USFDA) audit for Laurus Labs was successfully completed without Form 483 .
- Have received inspection closure report from USFDA for Duvvada facility: Dr Reddy's"We have received a written communication about the issuance of establishment inspection report (EIR) for FTO VII", said Dr Reddy's.
- Cadila Healthcare gains after Zydus receives EIR from USFDAThe scrip touched its fresh 52-week high of Rs 926.25 on December 28, 2016.
- Zydus Cadila gets EIR from USFDA for Pharma SEZ plant at AhmedabadThe company's "formulations manufacturing facility at Pharma SEZ, Ahmedabad has received an EIR from the USFDA signifying the successful cl...
- USFDA completed audit of Mexican plant: Dr Reddy's Laboratories"The audit of our API Cuernavaca plant in Mexico by the USFDA has been completed with zero observations," Dr Reddy's Laboratories (DRL) sai...
- Cadila receives audit closure reportThe Moraiya manufacturing plant had completed the USFDA audit from February 6th to 15th 2017 with Zero 483 observations, the company said.
- Dr Reddy's Labs jumps 3% on completion of USFDA audit at Srikakulam plantThe stock rose 3.04 per cent to hit a high of Rs 2,721.95 on BSE.
- USFDA report on Halol unit to be positive in long-term: SunThe company's Halol facility recently underwent an inspection by the US Food and Drug Administration (USFDA).
- USFDA inspects Sharon Bio-Medicine's Dehradun-based plantLast month, USFDA had issued a warning letter to the firm for failing to pay generic drug user fee by its owner for three years starting 20...
- India raises concerns over FDA actions on domestic drug firmsThe matter came up during a meeting here between Commerce and Industry Minister Anand Sharma and USFDA Commissioner Margaret A Hamburg.
- USFDA may visit Dr Reddy's Laboratories' Mexico facility this monthAmerican drug regulator USFDA may visit the facility for an inspection later this month, the company said.
- Aurobindo Pharma receives warning letter from USFDA; stock over 9 pc downAurobindo Pharma said it has received a warning letter from the USFDA with regard to its antibiotics manufacturing unit in Hyderabad.
- Aurobindo Pharma receives warning letter from USFDAAurobindo Pharma today said it has received a warning letter from the US health regulator with regard to its antibiotics manufacturing unit...
- Aurobindo to suffer $2-mn loss per month due to USFDA banAurobindo Pharma said they may incur a revenue loss to the extent of $2 million per month till the issue remains unresolved.
- FDA-approved inspectors plan short-notice audit of trialsUnder the scheme, a team of drug inspectors will walk into clinical trial centres at short notice and audit the internal processes and the ...
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