MIAMI--(BUSINESS WIRE)--Stratus Pharmaceuticals, Inc. and Tarmac Products, Inc. are pleased to announce that the U.S. Food and Drug Administration (FDA) inspected and approved its Miami Gardens manufacturing facility to be GMP (Good Manufacturing Practices) compliant. Tarmac can now apply for New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) without opposition from the FDA.
“This is a major milestone for Stratus and Tarmac,” said Alberto Hoyo, President of Stratus Pharmaceuticals. “We are committed to continuing to produce and distribute high-quality products for our longstanding clients.”
On April 28, 2017, Stratus Pharmaceuticals finalized the closing of its Carlstadt manufacturing facility and ceased manufacturing certain products. As a result, the following took place:
- Tarmac Products, Inc. took over all manufacturing of Stratus products.
- There were NO recalls for any Stratus products.
- There were NO interruptions in manufacturing and shipping of Stratus products.
- The Stratus Distribution Center in Miami, Fla. continues to be fully operational.
- The Florida-based manufacturing facility (Tarmac Products, Inc., Miami Gardens, Fla.) is fully operational and in conformance with the U.S. Federal Food, Drug, and Cosmetic Act.
“Stratus Pharmaceuticals continues its commitment to improving its products and increasing its production capabilities,” added Hoyo. In early 2013, the company acquired its Miami Gardens manufacturing facility located near its distribution center in South Florida. The 60,000 square foot plant is a climate-controlled facility manufacturing topicals, powders, suppositories, and eventually solid dosages.
“Stratus has invested time and finances to convert Tarmac Products, Inc. into a state-of-the-art facility,” said Hoyo. “We are immensely pleased that the FDA has given us its stamp of approval.”
Tarmac Products’ laboratory was also upgraded and modernized by adding state-of-the-art equipment, including Biolumix for rapid in-house microbiology testing.
Stratus Pharmaceuticals, Inc. operates as a pharmaceutical company that provides dermatology, plastic surgery, wound care, and podiatry products.