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Sigmapharm Laboratories.

BENSALEM, Pa. -- Sigmapharm Laboratories LLC is a privately held specialty pharmaceutical company engaged in the development, manufacture and marketing of unique generic and branded products.

The company, which says it owns or controls more than 80 domestic and international patents and patent applications, develops and manufactures a range of innovative products, including physically and chemically stable amorphous APIs and maximally stable and bioavailable dosage forms.

"We develop and manufacture products that most others cannot," Sigmapharm states, adding that it is proud to have its products manufactured and sold in the United States.

Spiro Spireas, the inventor of more than 80 international and domestic patents and author of more than 200 scientific papers, books and other publications in the fields of industrial pharmacy, biopharmaceutics, pharmacokinetics, pharmaceutical technology and analytical chemistry, founded Sigmapharm in 2005 and is the company's chairman and chief executive officer.

This month, the company announced the release of Acitretin Capsules (AB-rated to Soriatane capsules), with a primary indication for the treatment of severe psoriasis. Other Sigmapharm releases include Liothyronine Sodium Tablets, for hypothyroidism, which is the most stable Liothyronine product on the market with a shelf life of 36 months; Adefovir Dipivoxil Tablets, for hepatitis B, which is the first and only generic product equivalent to Hepsera Tablets; and Sodium Phenylbutyrate Powder, for urea cycle disorders, which is the first and only generic product equivalent to Buphenyl Powder.

Sigmapharm's product pipeline is expanding rapidly. This year, for example, Sigmapharm has filed to date three additional Abbreviated New Drug Applications with paragraph IV certifications, to complement the five other Sigmapharm ANDAs (three of which also contain paragraph IV certifications) currently awaiting FDA approval.

Sigmapharm states that its products are developed and manufactured using the company's proprietary drug delivery systems, which can effectively optimize drug solubility, bioavailability and stability. According to a senior Sigmapharm representative, the company has "one of the most innovative and efficient groups of scientists and inventors in the industry, who have pioneered the development of several unique pharmaceutical products currently marketed in the U.S."

The company says its potential for success is virtually unlimited, due to the backing of its proprietary technologies, its personnel's proven track record and its state-of-the-art R&D and manufacturing facilities.

3375 Progress Drive

Bensalem, Pa. 19020

Key contact:


Manager, Pricing and Contracts

Phone: (215) 352-6655

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Title Annotation:RX/Generic Drugs/Profiles
Publication:Chain Drug Review
Geographic Code:1USA
Date:Sep 28, 2015
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