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USFDA WARNING
Indoco Remedies gets warning letter from USFDA for Goa plantIndoco Remedies' Goa plant received a warning letter from the USFDA following a July inspection. The company stated its commitment to resol...
Aurobindo Pharma's Eugia Unit-3 gets warning letter from USFDA, shares fallAurobindo Pharma's subsidiary Eugia Pharma Specialities received a warning letter from the USFDA concerning its formulations manufacturing ...
Cipla slumps nearly 8% after USFDA warning letter for manufacturing lapsesAfter an inspection at the Pithampur plant, the USFDA issued a warning letter stating that the company's methods, facilities, or controls f...
USFDA warns Cipla for lapses in manufacturing practices at Pithampur facilityAccording to an exchange filing, the drug manufacturer was given a detailed breakdown of the lapses in methods followed at the facility by ...
Lupin says USFDA warning on Goa and Pithampur facilities are resolvedLupin on Thursday said it has received correspondence from the USFDA that it has now addressed the concerns raised in the Warning Letter fo...
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...
Torrent Pharma stock loses 3% on USFDA warning letterThe scrip was trading 2.59 per cent lower at Rs 1,623 on the NSE.
Glenmark shares hit 52-week low on USFDA warning letterUSFDA had inspected the facility between April 15 and April 20, Glenmark said.
Aurobindo Pharma plunges 8% on USFDA warningThis action follows the earlier inspection of the site by the USFDA in February 2019.
Sell Lupin, target Rs 800: Elara CapitalSell Lupin at a price target of Rs 800.
Lupin shares fall 3% as USFDA warns of regulatory actionUSFDA warned the firm that it may withhold approval of any pending applications or supplements in which this facility is listed.
Ban in US mkt due to change in drug shortage situation: IpcaThe ban on all drugs made at Pithampur and Silvassa will continue until the company can demonstrate that the drugs from these sites are in ...
Sun Pharma up 3% after clarifying USFDA warningShares of Sun Pharma surged over 3% in Wednesday's trade after the pharma giant issued clarification over the USFDA warning letter.
Dr Reddy's says new drug approvals will be delayedThe warning letter issued by the US Food and Drug Administration will impact Dr Reddy's new drug approvals, the company said.
Most pharma companies earn USFDA wrath over data integrity issuesThe US is the largest market for domestic generic companies, contributing 25-55% of revenues for large companies, while India supplies arou...
USFDA warning letter to Agila not to affect acquisition: MylanMylan said the USFDA warning letter to Agila Specialties over violation of manufacturing norms in one of its plants will not affect the Rs ...
USFDA scrutiny: Will pharma majors like Ranbaxy, Wockhardt be affected in long-term?Manufacturing-related indiscretions of Indian firms put a question mark on prospects for generics exports.
- Sun Pharma's US arm to reply to USFDA letter on Monday
Sun Pharma's US arm, Caraco Pharmaceutical, will file a response to the US Food and Drug Administration's warning on its quality standards ...