OAKLAND PARK, FL--(Marketwired - Jun 2, 2016) - BioStem Technologies, Inc. ("BioStem" or the "Company") (OTC PINK: BSEM) announced today that the FDA has accepted and issued BioStem Pharmaceuticals, Inc., a wholly owned subsidiary of the Company, its FDA Drug Establishment Registration Number and Labeler Code for Manufacturing and Repackaging of pharmaceutical products.
BioStem Pharmaceuticals is a pharmaceutical distribution and manufacturing company that is focused on the redistribution of Active Pharmaceutical Ingredients as well as development and approval of New Drug Applications. The FDA Establishment Registration and Labeler Code allows BioStem Pharmaceuticals to manufacture and distribute pharmaceuticals products in the United States.
The Office of Compliance, Immediate Office oversees the electronic Drug Registration and Listing System, a key component of the Food and Drug Administration's ability to monitor drug safety. Section 510 of the Federal Food, Drug, and Cosmetic Act requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S.
Joe Esposito, President of BioStem Pharmaceuticals, went on to say, "We are very excited to have this process completed. This now gives us the ability to move forward with the development and manufacturing of strategically chosen products that have been mapped out in our business plan."
About BioStem Technologies, Inc. (OTC PINK: BSEM): BioStem Technologies (OTC PINK: BSEM) is in the business of regenerative medicine and antiaging strategies throughout the United States, Europe, and Mexico. The Company's mission is to conquer the effects of biological aging (and related acute disease), and its strategy is to discover, develop, produce, and deliver the most effective stem cell and wellness products in the world. The Company is comprised of a diverse group of scientists, physicians, and industry visionaries who are creating innovative products for helping customers live their best, feel their best, and be their best. The company operates four strategic business units - BioStem Cell Therapy, BioStem Wellness, BioStem Pharmaceuticals, and BioStem International - providing a diversified line of products and services that include: clinical stem cell therapy, stem cell R&D, state-of-the-art laboratory services, pharmaceuticals, nutraceuticals, cosmeceuticals, API Repackaging, and medical tourism.
Forward-Looking Statements Except for statements of historical fact, the matters discussed in this press release are forward looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "future," "plan" or "planned," "expects," believe" or "projected." These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company's control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing, exploiting and protecting proprietary technologies, intense competition and additional risks factors as discussed in reports filed by the company with OTC Markets.