Phalanx Labs banned from shipping APIs to US after refusing inspection

By Gareth Macdonald contact

- Last updated on GMT

Phalanx Labs' site in Visakhapatnam, India banned by US FDA
Phalanx Labs' site in Visakhapatnam, India banned by US FDA

Related tags: Erectile dysfunction drugs, Active pharmaceutical ingredients, Pharmaceutical drug

The US FDA has banned Phalanx Labs from shipping products to the US after the Indian API and intermediates firm refused to let inspectors visit its site in Visakhapatnam.

The US regulator added Phalanx to its import alert list​ – also known as the Red List - on Wednesday and suggested the firm’s refusal to allow an agency team to visit its site could indicate manufacturing operations are not up to code.

The refusal to permit inspection of a foreign facility or provide reasonable access to FDA’s inspectional personnel, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions​.”

The facility – identified as Plot No.74B – produces 15 active pharmaceutical ingredients (API) – including those for erectile dysfunction drugs, ulcer medications and anticoagulants – and chemical intermediates according to the privately-owned firm’s website.

The site also provides contract manufacturing services for APIs and chemical intermediates. 

At the time of publication, Phalanx's websites states that its manufacturing operations comply with “regulatory requirements of various prominent international regulatory bodies, including Europe and US​.”

The firm also states the plant is ISO 9001-2008 compliant, accredited by Japan’s Ministry of Health, Labour and Welfare (MoH) and the WHO and has been issued with “written confirmation” of quality needed to ship APIs to the European Union.

Phalanx did not respond to a request for comment.

Related news

Show more

Related products

show more

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Innovations in OSD

Innovations in OSD

Recorded the 06-Oct-2020 | Webinar

This DFE series of educational webinars looks at innovations in Oral Solid Dose Forms with the emergence of advanced technologies such as Continuous Manufacturing...

Lactium, your ally to manage day to day stress

Lactium, your ally to manage day to day stress

Ingredia | 27-Aug-2020 | Product Presentation

Stress has been called the ‘health epidemic of the 21st century’ by the World Health Organization. Increasingly, consumers are looking for safe, reliable...

Related suppliers

Follow us


View more