Nastech Facility Cleared to Manufacture Nascobal

The FDA has approved Nastech Pharmaceutical Co. Inc.'s GMP manufacturing facility in Hauppauge, NY for commercial production of Nascobal, the company's product for treatment of vitamin B-12 deficiency. Nastech previously used a contract manufacturer to fill, package, and ship the product to its U.S. licensee, Schwarz Pharma Inc.

According to Isidoro Nudelman, Nastech's vice president of drug regulatory affairs, the approval represents "significant step" in the company's effort to broaden its business operations to include full manufacturing of commercial quantities of nasally delivered drug products.

"For the most part, we have the manufacturing capacity, process and personnel in place to improve gross margins as unit volume growth materializes, subject to approval by the FDA of our nasal drug pipeline," Nudelman added. "The next product to be manufactured at this site, subject to FDA approval, is intranasal scopolamine hydrobromide, which is indicated for the prevention and treatment of motion sickness."

Nastech is a drug delivery company specializing in the research, development, manufacturing, and commercialization of nasally administered pharmaceuticals.

For more information: Isidoro Nudelman, Vice President, Drug Regulatory Affairs, Nastech Pharmaceutical Co. Inc., 45 Davids Dr., Hauppauge, NY 11788. Tel: 631-273-0101. Fax: 631-273-0252.

Edited by Jim Pomager