Pisgah Laboratories, an API maker, will invest $55 million to upgrade its manufacturing facility in Pisgah Forest, North Carolina, to include sterile injectables and liquid filling operations.
The company is a subsidiary of India-based Ipca Laboratories. In 2015, the FDA banned Ipca's drugs after several years of inspection problems. Ipca then shelled out $9.65 million for Pisgah in 2018, and in 2020 the FDA ban was lifted.
Commenting on the annoucement about Pisgah's North Carolina site, Dani Bailey, a Pisgah spokesperson, said in a statement released by the North Carolina governor's office, “Carving a space in the highly competitive pharmaceutical market is not an easy task, but we welcome the challenge and intend to see many years of company growth, job creation and education opportunities for Pisgah Labs and western North Carolina.”
The project also includes the addition of a new pilot manufacturing facility, quality control lab, warehousing and microbiological labs. Additional details about the project, such as a completion date, weren’t disclosed.
Pisgah was founded in 1981 and won its first FDA approval to produce APIs in 2002. The company claims 31 patents and produces APIs for pain, Alzheimer’s and fibromyalgia medications.
Ipca's purchase of Pisgah followed the FDA action that put Ipca products from India on the agency’s imports alerts list. In 2016, the FDA issued a warning letter for three of Ipca’s India manufacturing sites, citing that the company’s employees regularly deleted failed testing data from computers and overwrote them with data that indicated APIs and products met standards. At the time, the FDA said Ipca’s senior management had been warned about the issues as early as 2013.