US-Manufactured API Urea From FDA-Registered Facility Available Q4 2014
Bangor, PA – BioSpectra announces its cGMP, US-manufactured ICH Q7-based Urea, intended for use as an active pharmaceutical ingredient (API), will be produced in its new FDA-registered facility in Bangor, PA in Q4 2014. Regulatory Packets, Validation Reports, and Type II Drug Master File Authorization are scheduled for contract customers of Bio Active Urea during Q2 2015.
BioSpectra’s Bio Active Grade Urea, Product Code UR22, will be manufactured in a qualified and validated ICH Q7-compliant API manufacturing suite as a highly purified crystal with optimum solubility, purity, and traceability. Future versions of Bio Active Urea will include liquid and spray-dried forms, both of which are currently scheduled for release in Q3 2015. This product will be added to the current portfolio that already includes BioSpectra’s Bio Excipient-Grade Urea, Product Code UR32, which is an ICH Q7-compliant Excipient supported by a Type IV Drug Master File.
“BioSpectra is committed to making highly pure, compliant, and traceable APIs and Excipients available to our industry,” said Richard Mutchler, President of BioSpectra. “UR22 Urea is one of the legacy products we intend to offer as an aggressively priced, exceptionally pure material, designed for its intended end use to support the biopharmaceutical and pharmaceutical industries.”
In keeping with BioSpectra’s history, contract customers of this API will receive preferential pricing and early access to this essential material. BioSpectra is committed to serving its target industries by launching a series of safe, US- manufactured, highly purified and synthesized alternatives to existing key ingredients not currently supported by Drug Master Files.
BioSpectra is an FDA-registered cGMP-compliant contract manufacturer and commercial producer of amino acids, biological buffers, carbohydrates, pharmaceutical excipients, and APIs. BioSpectra manufactures products for the biopharmaceutical industry in its state-of-the-art Pennsylvania facilities. Excipients manufactured by BioSpectra are produced in accordance with cGMP guidelines to provide the highest quality materials available to the biopharmaceutical industry. APIs manufactured by BioSpectra are produced in accordance with ICH Q7 guidelines to provide the highest quality materials available to the biopharmaceutical industry. For more information, visit www.BioSpectra.us.
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