Category: Pharmaceuticals

Akorn-Strides, LLC Announces FDA Approvals for Sterile Vancomycin HCl USP, 500 mg/Vial; 1 g/Vial and Sterile Vancomycin HCl USP, 5 g/Vial Pharmacy Bulk Package

Akorn-Strides, LLC today announced that the U.S. Food and Drug Administration has granted approvals for two Abbreviated New Drug Applications (ANDAs) for Sterile Vancomycin HCl USP, 500 mg/vial, 1 g/vial and Sterile Vancomycin HCl USP, 5 g/vial Pharmacy Bulk Package. Akorn-Strides, LLC is a Joint Venture that was formed in 2004 by Akorn, Inc. (NASDAQ: AKRX) and Strides Arcolab Limited (NSE: STAR) (BSE: 532531). The primary mission for the Joint Venture is to develop liquid, lyophilized and dry powder formulations of generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS medicines.

Sterile Vancomycin HCl is an antibiotic indicated for the treatment of potentially life-threatening infections which cannot be treated with other effective antimicrobial drugs, including the penicillins and cephalosporins. Recent IMS data estimates an annual market size for Sterile Vancomycin HCl of approximately $150 million. The expected launch date for these two new products is the first half of 2009.

The current product portfolio of the Joint Venture, which is funded equally by Akorn and Strides Arcolab, was recently expanded and now includes 29 ANDA’s with a total of 53 SKU's, or product line offerings. To date, the Joint Venture has filed for 18 ANDA’s and received 14 ANDA approvals. The Joint Venture generated its initial product revenues in the third quarter of 2008, from the launch of Rifampin for Injection.

Arthur S. Przybyl, Akorn’s President and CEO and Member Manager of Akorn-Strides, LLC stated, “These two important product approvals represent the largest market size opportunity for the Joint Venture to date. I would like to personally thank Arun Kumar, co-founder of the Akorn-Strides Joint Venture, for having built the necessary manufacturing infrastructure to allow the Joint Venture to effectively compete for market share.”

About Akorn, Inc.

Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company’s website at www.akorn.com.

About Strides Arcolab Limited

Strides, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is one of India’s largest exporters of branded generic pharmaceutical products. Strides manufactures pharmaceutical formulations in various dosage forms, including capsules, tablets and liquid injectables and is one of the world’s top five manufacturers of softgel capsules. Strides also has the only globally dedicated softgel facility for hormones. In addition, Strides undertakes contract research and the manufacturing of specialty chemicals for various multinational companies. Strides has a major presence in various developing countries such as Africa, Latin America and Asia as well as in developed markets such as the U.S., Canada and part of Europe. Strides is one of the largest Indian suppliers of institutionally funded aid projects and is an approved supplier to the Global Drug Facility, UNICEF, and MSF amongst others.

Strides has 14 manufacturing plants spread across the U.S., Brazil, Mexico, Italy, Poland, Singapore and India. This broad manufacturing network facilitates partnering with global organizations ranging from UNICEF and WHO-Global Drug Facility to European and American pharmaceutical multinationals, private labelers and distribution chains. Strides has product registrations in over 37 countries around the world and has earned ISO 9001, ISO 14001 and GMP accreditations including USFDA. Strides employs approximately 1,700 people across the globe. Strides also has a marketing presence in over 50 countries.

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