Third strike for Wockhardt as API facility hit with US import alert

By Dan Stanton

- Last updated on GMT

Image: iStock/suvisuni
Image: iStock/suvisuni

Related tags Import alert Food and drug administration Pharmaceutical drug

The US FDA has banned products from a third Indian manufacturing plant operated by Wockhardt.

The plant located in Ankleshwar, in the Gujarat region of India makes bulk active pharmaceutical ingredients (APIs) but a US Food and Drug Administration (FDA) import alert issued on Friday means the products are now banned from being exported to the US.

In a filing to the Bombay Stock Exchange, Wockhardt acknowledged the US FDA has updated the Import Alert 66-40 to include its API unit and said it was awaiting official communication from the US FDA on this matter.

The FDA’s actions come following an inspection last year which resulted in a Form 483, highlighting a number of manufacturing concerns.

“The Company has already initiated required steps to address the concerns raised by USFDA and is putting all efforts to resolve the matter,”​ Wockhardt added.

The API plant is the third Wockhardt facility to be banned from sending products to the US.

The company’s Waluj​ and Chikalthana​ finished formulation plants – both in Aurangabad, Maharashtra – were hit with an import alert, with products made at the sites placed under Detention Without Physical Examination (DWPE) by the FDA, in 2013.

Shares in Wockhardt fell by nearly 14% Monday, following the FDA’s announcement.

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...

Follow us

Products

View more

Webinars