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USFDA WARNING LETTER
USFDA pulls up Jagsonpal Pharmaceuticals for manufacturing lapses at API plantThe USFDA has issued a warning to Jagsonpal Pharmaceuticals following an inspection of its API plant in Rajasthan. The regulator highlighte...- 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...
- Natco Pharma gets warning letter from USFDA for Telangana plantNatco Pharma, a pharmaceutical company, received a warning letter from the USFDA regarding its manufacturing plant in Telangana. This came ...
- 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...
- 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...
- Aurobindo Pharma arm's New Jersey unit gets warning letter from USFDAThis follows the earlier letter dated June 4, 2020, issuing an OAI (Official Action Indicated) status for this facility.
- 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.
- Addressing points raised by USFDA: Vista PharmaThe Hyderabad-based company has been issued a warning letter by USFDA over significant violations of good manufacturing norms at its Nalgon...
- 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 ...
- Cadila Healthcare gets EIR from USFDA for Moraiya facility"What is 'closed' is the initial review that resulted in the warning letter issuance," Cadila Healthcare said.
- Will resolve issues raised by USFDA in a timely manner: DRLThe drug firm also said that the economic conditions in Venezuela continue to deteriorate further, increasing the risk of currency devaluat...
- 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.
- USFDA issues warning letter to Mumbai company Unimark RemediesUSFDA has issued a warning letter to Unimark Remedies for violating current good manufacturing practice norms at its plant near in Gujarat.
- 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 ...
- Sun Pharma's US arm to reply to USFDA letter on MondaySun Pharma's US arm, Caraco Pharmaceutical, will file a response to the US Food and Drug Administration's warning on its quality standards ...
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