Wockhardt data may delay US solithromycin review says Cempra after asking Uquifa for CMC info

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Food and drug administration

Cempra has asked Uquifa for API manufacturing data to support its US solithromycin efforts after raising concerns that information from Wockhardt in the current dossier will delay review.

North Carolina, US-based Cempra announced it had asked Uquifa for the information last week​.

The firm explained that the solithromycin dossier the Food and Drug Administration (FDA) accepted for review in January includes data generated at a Wockhardt plant in Ankleshwar, India that was later​ banned from shipping ingredients to the US.

Cempra said: “Based on an in person meeting held with the FDA in late October, we currently believe the FDA may not allow us to use API produced by Wockhardt for approval and commercial supply of solithromycin.

The firm added that: “we are preparing to provide the FDA with data from API that we are manufacturing with another API supplier​.”

Uquifa has been working with Cempra since 2014 when it started manufacturing supplies of solithromycin needed to support trials and regulatory submissions at its facility in Cuernavaca, Mexico.

Cempra said it expects to provide the US Food and Drug Administration (FDA) with data from Uquifa the next few months.

Solithromycin, which is intended to treat community acquired bacterial pneumonia (CABP) - is scheduled to go before the FDA’s Antimicrobial Drugs Advisory Committee on November 4 and has PDUFA dates in late December.

Barcelona, Spain headquartered Uquifa is owned by India’s Vivimed Labs which acquired the firm in 2011​.

In addition to the Mexico plant, Uquifa has manufacturing operations in Sant Celoni and Llica de Vall, Spain.

Related news

Show more

Related products

show more

Integrated Solutions for Accelerated Time to Market

Integrated Solutions for Accelerated Time to Market

Piramal Pharma Solutions | 08-Jun-2021 | Technical / White Paper

Facing capacity constraints? Lock in your program now! With 14 sites around the world providing diverse services ranging from discovery to drug substance...

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

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...

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