Pharmaceutics International, Inc. (Pii), a Contract Development Manufacturing Organization (CDMO), received FDA market approval for seven new products and commercially launched six products in 2017.
In early 2017, Pii conducted a cGMP baseline risk assessment and implemented remediation initiatives to enhance its cGMP systems. These initiatives yielded great results including successful MHRA and FDA inspections early in that year, and the approval and launch of numerous products, one of which was the Company's first oral solution product.
The 2017 FDA approved products include two oral tablets, one oral capsule, one oral solution, one oral suspension, and two sterile injectable products. Pii currently has multiple additional approvals pending, including a fast-tracked, aseptically pre-filled syringe product. Pii and its partners also launched four new products and relaunched two sterile injectable products to the market during the year.
