Akorn-Strides, LLC Announces First ANDA Submission for a Lyophilized Injectable Drug Product.BUFFALO GROVE, Ill. -- Akorn-Strides, LLC, a joint venture company formed between Akorn, Inc. (AMEX AMEX See: American Stock Exchange :AKN) and Strides Arcolab Limited (NSE NSE - Network Software Environment: a proprietary CASE framework from Sun Microsystems. :STAR), today announced that it has submitted its first Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA abbr. abbreviated new drug application ) with the Office of Generic Drugs for a lyophilized ly·oph·i·lize tr.v. ly·oph·i·lized, ly·oph·i·liz·ing, ly·oph·i·liz·es To freeze-dry (blood plasma or other biological substances). [lyophil(ic) + -ize. injectable drug. The proposed drug product is an antibiotic injectable used to treat or prevent infections, which currently has annual sales of over $80 million. Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "We are pleased to announce this new product submission. This submission highlights the fact that the joint venture can develop lyophilized drug products, and represents the JV's third ANDA submission in total." Arun Kumar, Executive Vice Chairman and Managing Director of Strides stated, "It is our continued focus to add niche products and create value to the Akorn-Strides JV. We are delighted that this particular product filing with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. would further consolidate the overall strategy." About Akorn, Inc. Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey Somerset is a census-designated place and unincorporated area located at the eastermost section within Franklin Township, in Somerset County, New Jersey. As of the United States 2000 Census, the CDP population was 23,040. Somerset housed one of the first Marconi Wireless Stations. 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 Arcolab Limited, listed on the Indian National Stock Exchange (STAR), Bombay Stock Exchange Bombay Stock Exchange (BSE) See: National Stock Exchange; Mumbai stock exchange. (STRIDES ARCO), Bloomberg (STR@IN) and Reuters (STAR.BO), has a global presence in more than 50 countries. The company has factories in India, Brazil, Mexico and USA. The Company supplies to a number of geographic locations including Latin America, UK, South East Asia, Africa, Australia and Russia. The Indian manufacturing facilities for the regulated markets are approved by all major regulatory bodies such as MHRA MHRA Medicines and Healthcare Products Regulatory Agency MHRA Modern Humanities Research Association (United Kingdom) MHRA Minnesota Human Rights Act MHRA Malta Hotels and Restaurants Association , EU, TGA and MCC (The Microelectronics and Computer Technology Corporation, Austin, TX) The first high-tech research and development consortium in the U.S., created in 1982 by leading companies within the electronics industry. . The company has recently signed supply and cooperation agreements with Aspen, South Africa, SORM SORM Shadow Ops: Red Mercury (game) SORM Sistema Operativno-Rozysknykh Meropriyatii (System for Operational-Investigative Activities; a Russian network eavesdropping/monitoring system) , Japan and Ribbon, Italy. Additional information is available at the Company's website at www.stridesarco.com. Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. Reform Act of 1995. Forward-looking statements give our expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, these include statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual results may vary materially, and there are not guarantees about the performance of our stock. Any forward-looking statements represent our expectations or forecasts only as of the date they were made and should not be relied upon as representing our expectations or forecasts as of any subsequent date. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, even if our expectations or forecasts change. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled "Cautionary Statement Regarding Forward-Looking Statements" in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Other factors besides those listed there could also adversely affect our results. |
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