FDA Approves Ascor
FDA Approves Ascor (Ascorbic Acid Injection, USP) for the Treatment of Scurvy
Santa Ana, California October 3, 2017 -- McGuff Pharmaceuticals, Inc., a wholly owned subsidiary of McGuff Company, Inc. announces the United States Food and Drug Administration’s New Drug Approval (NDA) of Ascor (Ascorbic Acid Injection, USP). Ascor is provided in a 50 mL vial labeled as a Pharmacy Bulk Package with a strength of 500mg/mL.
Ascor is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated.
Ascor is the first single moiety ascorbic acid drug approved for the US market and is the result of a multi-year development effort.
Ronald McGuff, CEO said "The FDA approval of Ascor Ascorbic Acid Injection USP will allow McGuff Pharmaceuticals, Inc. to deliver this medically necessary drug to US hospitals and pharmacies to improve patient health. In addition, McGuff Pharmaceuticals, Inc. currently holds Ascorbic Acid Injection USP approvals in multiple other countries."
McGuff Pharmaceuticals, Inc. is building a new 86,000 ft2 manufacturing facility in Santa Ana, Orange County, California to manufacture both branded and contract labeled sterile pharmaceutical products.
About McGuff Pharmaceuticals, Inc.
McGuff Pharmaceuticals, Inc. is a wholly owned subsidiary of McGuff Company, Inc. McGuff Pharmaceuticals is a Food and Drug Administration (FDA) inspected sterile fill manufacturer that maintains a tradition of quality and core competency in both FDA current Good Manufacturing Practices (cGMP) and International Organization for Standardization’s Quality Management Systems 9001, a unique combination for any pharmaceutical manufacturer.
McGuff Pharmaceuticals currently manufactures both branded and generic injectables under its own label as well as providing contract manufacturing services, for distribution to key market segments, both domestically and internationally. MPI also offers contract clinical trial services and international import / export regulatory services.
About McGuff Companies
The McGuff family of companies consists of four US and one foreign corporation. All corporations are family held and US veteran owned. McGuff Company, Inc. and subsidiaries provide the following diverse capabilities; US-based proprietary and CMO aseptic drug manufacturing, medical products distribution and 3pL logistics, pharmacy compounded drugs and Canadian drug distribution.
Source: McGuff Pharmaceuticals, Inc.
Posted: October 2017
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