Granules India's paracetamol facility passes USFDA inspection

Tags: Companies
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.

EDITORIAL OF THE DAY

  • Modi’s interview with Times Now failed to reveal the mind of the man

    For a prime minister, who prefers monologue and one-way conversation on twitter and radio to long-winded one-on-one interviews, Narendra Modi’s 85-m

FC NEWSLETTER

Stay informed on our latest news!

TODAY'S COLUMNS

Arun Nigavekar

Teachers must accept innovation

University teachers had been complaining for the past two years ...

Zehra Naqvi

How does a bird learn to sing?

There’s nothing like bir­dsong to give you a taste of ...

Dharmendra Khandal

The unfortunate death of a tigress & its repercussions

In nature it is not easy to gather investigative evidences, ...