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

Eastern & Western Manufacturing Solutions

Eastern & Western Manufacturing Solutions

Piramal Pharma Solutions | 07-Dec-2021 | Technical / White Paper

The best manufacturing site for a product can change throughout the life cycle. When bringing new drugs to market, biopharma companies may benefit from...

Flexibility and capability in pre-filled syringes

Flexibility and capability in pre-filled syringes

Curia | 15-Nov-2021 | Technical / White Paper

Pre-filled syringes have risen in popularity in recent years but the pandemic’s impact on drug development, manufacturing and patient care has created...

Related suppliers

Follow us

Products

View more

Webinars