Existing Progress Towards ANDA Approval of Hydroxyprogesterone Caproate Injection, USP


Santa Ana, CA (PRWEB) June 19, 2013

McGuff Pharmaceuticals, Inc. continues to pursue the approval of an Abbreviated New Drug Application (ANDA) for Hydroxyprogesterone Caproate Injection, USP 250mg/mL, 5mL, a number of dose vial a generic version of Bristol-Myers Squibbs drug fomerly identified as Delalutin. We are supplying this update in response to varied inquiries relating to the anticipated approval and marketplace introduction dates for McGuffs Hydroxyprogesterone Caproate Injection, USP drug solution.

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Regarding the status of our pending ANDA, to date, McGuff has responded to all Food and Drug Administration (FDA) inquiries concerning the ANDA submitted in October 2009. Even though we are hopeful that a final choice will be produced quickly, McGuff can not predict when the Agency will make its final determination regarding the ANDA approval. We remain committed to bringing Hydroxyprogesterone Caproate Injection, USP to market place as quickly as attainable.

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Our commitment to bring cost powerful branded and generic injectable drugs to the U.S. and International markets, for the benefit of sufferers in need, continues to be 1 of our driving principles.

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If you would like far more information about this subject or to schedule an interview with Damon P. Jones, Vice President of McGuff Pharmaceuticals, Inc., please get in touch with Maureen French at 800-603-4795 x301 or email mfrench(at)mcguff(dot)com. You may possibly also check out our web site at http://www.mcguffpharmaceuticals.com.

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About McGuff Pharmaceuticals, Inc.

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McGuff Pharmaceuticals is a Meals and Drug Administration (FDA) inspected sterile fill manufacturer that maintains a tradition of good quality and core competency in each FDA current Great Manufacturing Practices (cGMP) and International Organization for Standardizations Top quality Management Systems (ISO) 9001:2008, a unique mixture for any pharmaceutical manufacturer.

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The McGuff family members of firms supplies commercial pharmaceuticals, compounded drugs, nutritional supplements, medical merchandise and contract services used by leading healthcare organizations and specialists.

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The McGuff loved ones of companies involves:

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McGuff Organization, Inc. Corporate Headquarters and Medical Items Distribution Center

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Subsidiaries:

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McGuff Pharmaceuticals, Inc. Industrial drug manufacturing&#13

McGuff Medical Canada, Inc. Healthcare goods distribution&#13

McGuff Compounding Pharmacy Services, Inc. Pharmacy and Compounded drugs

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