QuVa Pharma Announces Licensure under California’s SBOP New 503B Outsource License Category
QuVa has commenced shipments to California hospitals including current drug shortage products
Sugar Land, TX –July 5, 2017 – Following comprehensive cGMP audit of QuVa Pharma’s Sugar Land and Temple, Texas facilities, the California Board of Pharmacy has issued Outsource Facility licenses to both QuVa locations. The California Board of Pharmacy introduced this category of license in 2017 recognizing that FDA’s 503B regulations require Outsource Facilities to meet cGMP standards as opposed to traditional pharmacy US <797> guidelines. QuVa believes it is one of the first 503B registered business to achieve this license status in California.
QuVa is supplying California hospitals with Sodium Bicarbonate PF 8.4% (1mEq/ml) 50ml in a syringe (50mEq per syringe), as well as other products from its comprehensive product catalogue, including other drug shortage products Calcium Chloride, Potassium Phosphate, and Rocuronium.
“We are delighted to be one of the first recipients of this new category of California licensure which reinforces our industry leading position in cGMP compliant operations”, commented Stuart Hinchen, CEO and Co-Founder of QuVa Pharma. “California State Board of Pharmacy continues to be one of the most strident proponents of product quality standards in the country”. Hinchen commented further that “QuVa’s ability to provide high quality products, including chronic drug shortage product such as Sodium Bicarbonate, is providing California based hospitals with immediate access to medicine to continue patient care.”
QuVa’s range of products are all compounded from starting material that is FDA approved, and each shipment is accompanied by a Certificate of Analysis verifying Sterility, Potency, and Endotoxin levels of the product.
QuVa is the market leader in quality compliance with both Texas facilities in excellent standing with the FDA, having received the Inspection Close out report in March 2017 for the main Sugar Land, Texas campus. QuVa is opening the first phase of its 160,000 sq ft New Jersey facility in July 2017, with further expansion at that site on schedule for commissioning in Q4 2017.
For product ordering enquiries please contact QuVa Customer Service at 888.339.0874 or via email
About QuVa Pharma, Inc.
QuVa Pharma is a nationally recognized company emerging as the leading industry 503B platform and partner of choice for compliance-oriented healthcare facilities looking to ensure a quality, safe and consistent supply of medications. The Company offers a broad portfolio of products across Pain Management, Anti-infective, OR Syringes, Labor and Delivery therapeutic areas amongst others, all of which are released only once sterility, potency, and Endotoxin testing is successfully complete, and with validation supporting appropriate BUD. The company is committed to having a patient-first orientation, as well as a robust product portfolio, leading safety standards, and collaborative, partnership-oriented customer service. For more information, visit www.quvapharma.com.