API launch from new Cambridge Major Laboratories facility
This is the first commercial launch of an active pharmaceutical ingredient from its newest facility
With facilities in the US and the Netherlands, the chemistry outsourcing company produces pharmaceutical intermediates and APIs from early preclinical development to commercial manufacture.
CML's two manufacturing facilities were the subject of a FDA inspection, which included a pre-approval inspection and a general quality systems inspection. This was the first for Cambridge Major's newest, large scale API manufacturing facility and the seventh inspection over the past nine years.
Within two months of the successful FDA pre-approval inspection, the FDA announced approval of the product which represents the first commercial product produced in Cambridge Major's new large scale facility. The approval adds to Cambridge Major's momentum as the company continues to add employees and services.
‘The NDA approval is a significant milestone for our newest facility and a clear sign that we are open for business at the facility. This particular CML facility is truly state-of-the-art and affords CML the capacity for growth and to continue serving customers with the highest level of service,’ said Brian Scanlan, president and ceo of CML.
You may also like
Trending Articles
You may also like
Manufacturing
CorMedix sees NDA approval delay due to CMO and API supplier issue
A Complete Response Letter (CRL) was received from the FDA stating that the DefenCath NDA cannot be approved until deficiencies recently conveyed to the contract manufacturing organisation and the supplier of the API heparin during inspections are resolved
You need to be a subscriber to read this article.
Click here to find out more.
Click here to find out more.
You need to be a subscriber to read this article.
Click here to find out more.
Click here to find out more.