Granules India's paracetamol facility passes USFDA inspection

Drug firm Granules India's paracetamol manufacturing facility at Bonthapally in Andhra Pradesh has passed an inspection by the US health regulator.

The company's paracetamol facility has successfully passed a United States Food and Drug Administration (USFDA) inspection without any '483 observations', Granules India said in a filing to the BSE.

"The facility has the world's largest single active pharmaceutical ingredient (API) production line by volume," it added.

An FDA Form 483 is issued to the firm's management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and other related acts.

The company's four API facilities have passed the USFDA inspections in the past 12 months, Granules India said.

Hyderabad-based Granules India has facilities for APIs, pharmaceutical formulation intermediates (PFIs) and finished dosages, serving customers in over 60 countries.

Shares of Granules India were trading at Rs 401.75 per scrip in the afternoon trade today, up 1.40 per cent from its previous close, on the BSE.

Post new comment

E-mail ID will not be published
CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.

EDITORIAL OF THE DAY

  • Lawmakers must not dilute penalties for insurers on mis-selling

    The much delayed insurance laws (amendment) bill is back in the news and the positive statements of finance minister Arun Jaitley suggest that the gov

FC NEWSLETTER

Stay informed on our latest news!

INTERVIEWS

GV Nageswara Rao

MD & CEO, IDBI Federal Life

Timothy Moe

Goldman Sachs

Chander Mohan Sethi

CMD, Reckitt Benckiser India

COLUMNIST

Arun Nigavekar

New model for effective education

After interacting with students and teaching community on a ...

Zehra Naqvi

Being unrealistic can be good for you

Depression is a term that most people use very casually ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture