Frontida site receives US FDA all-clear for former Sun Pharma site

By Flora Southey

- Last updated on GMT

iStock/Thinglass
iStock/Thinglass

Related tags Warning letter Pharmacology

The US Food and Drug Administration (FDA) has given the go ahead to Frontida BioPharm’s Pennsylvania, US-based site, eight months after distributing a Warning Letter for the facility.

The Warning Letter responded to evaluations made in June and July 2015, when the site was owned by Indian drug maker Sun Pharma.

Contract development and manufacturing organization Frontida acquired​ the Pennsylvanian site and an Illinois-based site from Sun Pharma in June, 2016, and received the FDA Warning Letter two months later.

FDA issued the Warning Letter​ in response to breached GMP regulations, including the release of 27 lots of clonidine HCI tablets containing potentially contaminated active pharmaceutical ingredients (APIs).

Remediation activities

Frontida COO Ron Connolly told In-PharmaTechnologist Sun Pharma had helped Frontida address the problems identified by the FDA.

“Immediately upon the acquisition, Frontida established a new quality leadership team for the operations, reorganized and added scientists to the existing laboratory teams to improve workflows, and implemented corrective and preventative actions that included investing in a new electronic quality management system,” ​he told us.

New products

Frontida also announced that it plans to hire an additional 40-50 personnel in the next 6 months to support planned new prescription and OTC drugs for the US and international markets.

“Frontida is also partnering with pharmaceutical companies to launch 20 products that were previously approved at the facilities. Frontida’s partners will launch seven products in the US by the end of 2017,” ​said Connolly.

Frontida supplies prescription and OTC products, Highly Potent Active Ingredients (HPAI), fixed-dose combination products and DEA schedules II-V products.

Related news

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),...