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.

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