USFDA ban on Toansa plant disappointing: Ranbaxy

Terming the USFDA ban on its Toansa plant 'disappointing', Ranbaxy Laboaratories today said it will take 'appropriate management action' for the lapses at the manufacturing facility after the conclusion of an internal investigation.

The company is disappointed with the recent US Food and Drug Administration (USFDA) action and would like to apologise to all its stakeholders for the inconvenience caused by the suspension of shipment, Ranbaxy Laboratories said in a statement.

"This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation," Ranbaxy CEO and Managing Director Arun Sawhney said.

USFDA has notified the company that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products, it said.

The US health regulator had earlier this month issued the Form 483 to the company for its Toansa plant in Punjab for violations of the current good manufacturing practice (CGMP).

"Subsequent to the Form 483 issued in early January 2014, Ranbaxy voluntarily and proactively suspended shipments of API from this facility to the US market when it received the inspection findings," the company said.

Ranbaxy’s other key facilities at Ponta Sahib (Himachal Pradesh) and Dewas (Madhya Pradesh) are already under an US import alert since 2008. Last year, its other key facility at Mohali also came under USFDA import alert.

"With this import alert, the operations of the company in US business which contributes around 40 per cent could come under impact, unless it can compensate for the same at the earliest and mange a smooth supply of key raw material," Angel Broking VP - Reasearch Pharma Sarabjit Kour Nangra said.

Shares of Ranbaxy were trading at Rs 351.50 apiece on the BSE, down 15.74 per cent from its previous close.

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E-mail ID will not be published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

  • Sanskrit does not compare with German in the job market

    While there can be no argument that the importance of Sanskrit as an all-India language needs to be emphasised, particularly for the young generation

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

M S Swaminathan

Public good research in agriculture

Public good research in agriculture is designed to promote risk ...

Purnendu Ghosh

Why we must know the rules of the game

We like to believe that people are good and we ...

Shona Adhikari

Pop art is truly a feast for the eyes

The internationally reknowned Bruno Art Group’s presence in India had ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture