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...
23 Nov, 2023, 03.13 PM IST
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...
28 Jun, 2022, 12.54 AM IST
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...
27 Jun, 2022, 06.50 PM IST
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...
27 Jun, 2022, 05.39 PM IST
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.
22 Oct, 2020, 10.55 AM IST
Torrent Pharma stock loses 3% on USFDA warning letterThe scrip was trading 2.59 per cent lower at Rs 1,623 on the NSE.
10 Oct, 2019, 12.14 PM IST
Glenmark shares hit 52-week low on USFDA warning letterUSFDA had inspected the facility between April 15 and April 20, Glenmark said.
07 Oct, 2019, 03.49 PM IST
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...
13 Jul, 2017, 05.58 PM IST
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 ...
20 Jun, 2017, 04.56 PM IST
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.
08 Jul, 2016, 04.14 PM IST
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...
09 Feb, 2016, 04.30 PM IST
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.
23 Dec, 2015, 10.29 AM IST
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.
09 Nov, 2015, 06.19 PM IST
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.
15 Oct, 2015, 05.37 AM IST
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...
29 Dec, 2014, 01.27 PM IST
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 ...
17 Sep, 2013, 06.02 PM IST
- 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 ...
23 Nov, 2008, 02.42 PM IST