Just eight months after receiving an FDA warning letter for a U.S. plant that it bought from Sun Pharma, Frontida BioPharm says the agency has given the plant an all-clear. The warning was tied to issues that the FDA uncovered at the finished pharmaceutical plant in Philadelphia before Frontida took over the plant last June.
With the regulatory issues behind it, the CDMO said it can now move forward with expansion plans it has for the Philadelphia plant and one in Aurora, Illinois, that was also part of the deal with Sun.
“The positive resolution of our regulatory status with the FDA will stimulate Frontida’s expansion and growth, and enable Frontida to better support our partners to bring new products to the market,” Frontida CEO Song Li said in a statement.
The company already has added more than 65 quality and scientific professionals to the 155 employees who worked at the operations when it was acquired last year. It plans to add 40 to 50 more workers over the next six months, Frontida said Monday, as it launches new products from the two plants.
The warning letter was issued last August and was tied to problems the FDA noted during a 2015 inspection. Frontida knew about the regulatory issues when it acquired the facilities last year from India’s largest drugmaker and has said that Sun helped it deal with them. Sun had bought the facilities from Japan’s Takeda in 2012 and was on the cusp of closing the plants when Frontida took them over.
The issues included the fact that the Philadelphia plant had “knowingly released 27 lots of various strengths of clonidine HCl tablets in March 2015....” despite evidence that the API in the drug “was potentially contaminated.”
The Philadelphia plant is only one of a number of Sun Pharma facilities to have been cited by the FDA in the last few years. In 2015, the FDA issued a warning letter to Sun Pharmaceutical in Halol, India, which is key to its U.S. drug launches. Last month, the company acknowledged it had received a Form 483 with 11 observations for another solid dose formulation plant in Dadra, India.