Observations

The US FDA concluded its good manufacturing practices (GMP) inspection of Biocon's API facility on 14 June 2024.

Dr. Reddy’s Hyderabad plant handed 10 US FDA observations

This was a routine cGMP inspection at our formulations manufacturing facility (FTO-3) in Hyderabad.

Ajanta Pharma soars after US FDA issues no observations at Dahej plant

Stock rises after investors cheered the fact that its Dahej plant, which was inspected by the US drug regulator between April 3 and April 7, saw no Form 483s being issued.

USFDA issues import alert for Divi's Labs Vizag unit

An import alert from the regulator means that products from the facility meant for imports can be refused without a complete physical examination.

Dr Reddy's slips 3.5% on 13 USFDA observations for Duvvuda unit

The US drug regulator issued the observations for its oncology formulation facility at Duvvuda in Visakhapatnam‘s SEZ. The site is important given Dr Reddy‘s focus on complex generic filings.

Unichem gets two US FDA observations for its Ghaziabad plant

"The two observations cited are, in the opinion of the company, correctable ones in respect of which the company will file the necessary response within the stipulated period of 15 working days," Unichem said in a statement to stock exchanges.

Can sort out USFDA concerns on Telangana plant: Dr Reddy's

A company executive said on Tuesday that the US drug regulator's observations on its active pharmaceutical ingredient plant at Miryalaguda are minor and easily addressable.

Environment Ministry gives observations on jallikattu proposal

The Environment Ministry today gave its observations to the proposal sent by the Tamil Nadu government for lifting of the ban on bull-taming sport jallikatu and returned it to the Home Ministry for final decision.

Granules plant gets 11 observations from Portugal authority

Drug firm Granules India today said it has received 11 observations from Portugal's health authority INFARMED for its manufacturing facility located at Gagillapur in Telangana.

Here‘s how analysts view Sun Pharma post Mohali plant inspection

Mohali plant has been out of operations for the US markets since 2013, so the functional contribution to US is nil.

Alkem Labs falls 8% on 13 observations from USFDA for Daman unit

Alkem Laboratories shares fell over 8 percent intraday Friday on several observations from the US health regulator for Daman facility.

Lupin to see approvals after US FDA gives clean chit: Macquarie

Of the total 18 observations, 9 from July 2015 and another 9 from March 2016 inspection, the former ones relating to equipment and warehousing have been closed. Nine observations are still outstanding for the company.

US FDA issues 3 observations on Cadila's Ahmedabad facility

The US food regulator is said to have conducted its inspections on the facility as early as January of this year. Already, Cadila is reeling under the warning letter it received on its Moraiya facility in January.

USFDA observations won't hit Natco product launches: Nirmal Bang

Sumit Singhania of Nirmal Bang says that the observations are minor and can be resolved easily.

US FDA inspects Aurobindo, Lupin plants

US regulator conducted inspections in oral solid facilities of Aurobindio - Unit 3 and Unit 7. While the Unit 3 was cleared with no form 483 for observations, Unit 7 saw few observations from the regulator.

Granules India facility gets 3 observations from USFDA

US Food and Drug Administration (USFDA) completed the inspection of company's two facilities, one located at Vizag in Andhra Pradesh and another at Jeedimetla in Telangana, Granules India said in a regulatory filing.

Citi maintains 'buy' on Wockhardt, target Rs 2,500

Citigroup Global Markets maintained its "buy" rating on pharma major Wockhardt, saying recent plant inspection and subsequent observations raised by US Food and Drug Administration wouldn't have any immediate impact on the co's business.