FORM 483

More in FORM 483

• No data integrity or repeat observations in the Form 483 we received: Kedar Upadhye, Cipla

  We are in the process of drafting a very robust response to each of the observations in the Form 483.

  

• Cipla falls 5% on fears of action against Goa unit

  According to Equirius, the unit received Form 483 with 12 observation that runs through 38 pages. Observations are largely related to procedure and SOP lapses, it said.

  

• Dr Reddy’s Labs down after USFDA observations

  We have received a Form 483 with 8 observations. We will address them comprehensively within the stipulated timeline, the company said.

  

• Audit of Laurus Labs completed by USFDA without objections

  The maiden United States Food and Drug Administration (USFDA) audit for Laurus Labs was successfully completed without Form 483 .

  

• USFDA issues 5 observations to Dr Reddy's plant in Hyderabad

  "The audit of our active pharmaceutical ingredient (API) manufacturing plant 2 at Bollaram, Hyderabad by the United States Food and Drug Administration (USFDA), has been completed today," Dr Reddy's said in a filing to BSE.

  

• Alembic Pharma gets 3 observations from USFDA for Gujarat plant

  New Delhi, Mar 21 () Alembic Pharmaceuticals today said the US health regulator has made three observations after inspecting its formulation facility in Panelav, Gujarat.

  

• Dr Reddy's gets 4 observations from USFDA for Telangana plant

  "The audit of our API Hyderabad plant 1 at Jinnaram Mandal, Medak district, Telangana, by the USFDA has been completed today. We have been issued a Form 483 with four observations which will be addressed comprehensively within stipulated time," Dr Reddy's said in a regulatory filing.

  

• Biocon Malaysia unit gets FDA Form 483 notice

  Indian pharmaceutical giant Biocon on Wednesday told the BSE that the US-FDA (Food and Drugs Administration) has issued a Form 483 with six observations for its manufacturing facility in Malaysia.

  

• Shilpa Medicare gets EIR from USFDA for Jadcherla facility

  The US health regulator has issued an EIR for the company's generic pharmaceutical manufacturing facility at Jadcherla, which was inspected between July 24-28, 2017, Shilpa Medicare said in a filing to BSE.

  

• Divi's Laboratories plunges 7% on receiving Form 483 from USFDA

  Following the development, the stock fell 6.88 per cent to Rs 895.50 on BSE. It opened at Rs 886 and touched an intraday high and low of Rs 923.85 and Rs 874.70 respectively, in trade so far.

  

• Divi's Labs gets 6 USFDA observations for Vizag unit

  The Hyderabad-based drug maker said the observations were procedural. It however did not elaborate on them.