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History



Early History and Origin of Osmotica


In 1939, Laboratorios Phoenix ("Phoenix") was founded in Buenos Aires, Argentina. Over the course of many years, Phoenix successfully developed a broad portfolio of medicines across several therapeutic areas, including cardiology, gastroenterology, neuroscience, metabolics and urology. Phoenix eventually grew to become one of the top ten largest pharmaceutical companies in Argentina.

In 1986, Phoenix began researching novel drug delivery systems, including osmotic and transdermal release technologies. Shortly after beginning their research and upon recognizing the potentially powerful applications of these technologies, Phoenix created and established a new, Technical R&D Division of the company, which would focus on innovative methods of drug delivery technology.

From its inception in 1986 through the late 1990's, the Technical R&D Division contributed to many successful product launches for Phoenix in Argentina and other Latin American markets. These significant early successes led to the decision to spin off Phoenix's Technical Division in 2000 in order to create a new, independent company, Osmotica, with the goal of utilizing its osmotic technology to provide better therapies and unique alternatives to fulfill unmet patient needs. (Phoenix continued to operate as a separate and highly successful independent company until it was acquired by GlaxoSmithKline in 2010.)

Today, Osmotica Pharmaceutical maintains a significant presence in Argentina, where the company was founded. Led by Dr. Joaquina Faour, the company's Argentina facility is home to a highly talented team of scientists, pharmacists and engineers and serves as Osmotica's hub for early Research & Development as well as Engineering for its proprietary manufacturing systems and equipment.




Osmotica Timeline - 2000 to Present


Osmotica Pharmaceutical is established as an entity and enters into a development relationship with Aventis (now Sanofi-Aventis) to develop a 24-hour release Allegra-D® product using Osmodex® technology. Numerous Osmotica-licensed products are launched in South American and Asian markets. (Allegra-D® is a registered trademark of Sanofi-Aventis U.S. LLC.)



Osmotica Pharmaceutical begins U.S. operations with the intent of developing ANDA and NDA products for registration with the U.S. FDA.



Allegra-D® 24-Hour Tablet is filed with the U.S. FDA. (Allegra-D® is a registered trademark of Sanofi-Aventis U.S. LLC.)



Osmotica submits Nifedipine Extended Release 30 mg, 60 mg and 90 mg tablet ANDAs to the FDA.


The company forms a strategic alliance with Schwarz Pharma as a contract manufacturer and marketing partner for the Nifedipine products.



Nifedipine Extended Release ANDAs are approved by the FDA and launched in conjunction with Kremers Urban, a division of Schwarz Pharma.



An agreement for distribution of Nifedipine in Canada is concluded.


Nifedipine Extended Release 90 mg tablet product is launched in the U.S. - the first true generic of Procardia XL® 90 mg. (Procardia XL® is a registered trademark of Pfizer Labs.)



Osmotica receives NDA approval for Venlafaxine Hydrochloride Extended Release 37.5 mg, 75 mg, 150 mg and 225 mg tablets for the treatment of Major Depressive Disorder (MDD) and Social Anxiety Disorder (SAD).



Oxybutynin Chloride Extended Release 5 mg, 10 mg and 15 mg tablets ANDA is approved - Osmotica's second difficult-to-manufacture generic product utilizing proprietary osmotic delivery technology brought to the market in five years.



Osmotica opens up an 85,000-square-foot research, development, and manufacturing facility in Marietta, Georgia.



Osmotica received the approval of Desvenlafaxine Extended Release Tablets. Osmotica also initiated the Phase 3 clinical trials for Arbaclofen Extended Release Tablets.



Osmotica initiated the Phase 3 clinical trials for Amantadine Extended Release Tablets.



Osmotica Holdings Corp and Vertical / Trigen Holdings, LLC successfully complete combination.

Vertical / Trigen was founded in 2003 and was primarily a Commercially-driven organization, focusing on branded Women's Health and Neuroscience products as well as a broad portfolio of value-driven generic medicines. As part of the new entity, Vertical / Trigen now serves as the Commercial engine for the combined company, leveraging its capabilities and infrastructure to sell, market and distribute Osmotica's full portfolio of products.



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