Pii and Its Partners Received FDA Market Approval for Seven Products and Commercially Launched 6 Products in 2017
Posted on February 8, 2018 at 10:59 ET
HUNT VALLEY, MARYLAND (February 8, 2018) - Pharmaceutics International, Inc. (Pii), a Contract Development Manufacturing Organization (CDMO) based in Hunt Valley, Maryland, together with their partners, 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.
During 2017, the FDA approved seven products for the Company and its partners, including 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.
These successful approvals and launches give Pii great momentum as it moves into 2018.
About Pharmaceutics International, Inc.
Pii is a privately held CDMO providing dosage form development and cGMP manufacturing services to
the global pharmaceutical industry. Headquartered in Hunt Valley, Maryland USA, Pii’s services include pre-formulation development, and clinical and commercial cGMP manufacturing of parenterals, liquid solutions and oral solids, including soft gels, tablets and capsules. In addition, the Company offers containment suites to handle potent drugs and Schedules I-V controlled substances.