Pii and Its Partners Received FDA Market Approval for Seven Products and Commercially Launched 6 Products in 2017

HUNT VALLEY, Md.Feb. 8, 2018 /PRNewswire/ — 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.



Contact:
Syed E. Abidi
Chairman and CEO
Pharmaceutics International, Inc.
10819 Gilroy Road
Hunt Valley, MD 21031
Tel: +1 410 584 0001
Email: seabidi@pharm-int.com

SOURCE Pharmaceutics International, Inc.

 

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