Research & Development
Pii & partners awarded US FDA's market approval for seven products and announces commercial availability of six products in 2017
9 February 2018 -

cGMP manufacturing services company Pharmaceutics International Inc (Pii) reported on Thursday the receipt of the US FDA 'smarket approval for seven new products plus the commercially availability of six products in 2017 in collaboration with its partners.

According to the company, the seven US FDA approved products include two oral tablets, one oral capsule, one oral solution, one oral suspension and two sterile injectable products.

Currently, the company has multiple additional approvals pending, including a fast-tracked, aseptically pre-filled syringe product. It has launched four new products and relaunched two sterile injectable products to the market during the year along with its partners.

Early last year, the company conducted a cGMP baseline risk assessment and implemented remediation initiatives to enhance its cGMP systems. It has announced successful MHRA and FDA inspections as well as the approval and launch of numerous products, one of which was the first oral solution product.