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Breckenridge Pharmaceutical, Inc.

 TOWA PHARMACEUTICAL CO.,LTD.

Breckenridge Pharmaceutical, Inc., the U.S. subsidiary of Towa Pharmaceutical (Osaka, Japan), markets and distributes quality, cost-effective generic pharmaceuticals in the United States.  Our products are developed in our affiliated research and development centers, as well as through strategic partnerships nationwide and around the world. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and lives of the patients we and our customers serve.

 

 

Latest News

Tentative Approval For Generic Pradaxa (Dabigatran)

Apr 22,2022

Breckenridge Announces Tentative Approval of its ANDA for Dabigatran  Etexilate Capsules (generic for Pradaxa®)

Berlin, Connecticut, April 22, 2022

Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted tentative approval of its Abbreviated New Drug Application for Dabigatran Etexilate Capsules (generic for Pradaxa®). This product development was a collaboration between Towa Pharmaceutical Europe, S.L. coupled with an external contract manufacturing organization.  Breckenridge has the three strengths consistent with the brand – 75mg, 110mg, and 150mg.  According to industry sales data, Pradaxa generated annual sales of $455 million during the twelve months ending February 2022. 

About Breckenridge:

Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical (Osaka, Japan), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients.  With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and quality of life of the patients we and our customers serve.

www.bpirx.com

For further information, please contact:

Breckenridge Pharmaceutical, Inc.

Robert Gasparino, Associate Vice President – Business Development

Tel: 860-828-8140

E-mail: rgasparino@bpirx.com

 

*All brand names and trademarks are the property of their respective owners.

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New-Product Agreement with PTS Pharma Signed

Apr 22,2022

Breckenridge Signs New-Product Agreement with PTS Pharma

Berlin, Connecticut, April 22, 2022

Breckenridge Pharmaceutical, Inc. announces today that it has signed a new-product agreement with PTS Pharma, LLC. under which PTS will support a technology transfer to Towa Pharmaceutical Europe, S.L. of a complex "For Suspension" product developed by PTS.  The remainder of development and commercialization will be performed at the Towa facility.  According to industry sales data, the product and its generics had annual sales of approximately $75 million during the twelve months ending February 2022. The companies are actively negotiating and look forward to collaborating on additional complex formulations under the same business model.

About Breckenridge:

Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical (Osaka, Japan), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients.  With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and quality of life of the patients we and our customers serve.

www.bpirx.com

About PTS Pharma, LLC:

PTS Consulting, LLC and PTS Pharma LLC., is a formulation development, clinical trial production, regulatory services and analytical control laboratory based in Kansas.  PTS Consulting is actively involved in regulatory consulting services. PTS Pharma operations include the capability and expertise to develop complex formulations of tablets, capsules, granules, modified dosage forms, topical dosage forms, suppositories, film products, solution, and suspension formulations and sterile injectables, with involvement in multiple aNDA and NDA filings over the years.   The activities are housed in dedicated GMP suites in the facility in Kansas City, USA. PTS Pharma is also involved in active raw material clinical production by fermentation technology processes. The firm was founded in 2003 by Paul Sudhakar, an industry veteran who is the Owner, President, and CEO of the firm.

www.ptsglobalservices.com

For further information, please contact:

Breckenridge Pharmaceutical, Inc.

Robert Gasparino, Associate Vice President – Business Development

Tel: 860-828-8140

E-mail: rgasparino@bpirx.com

*All brand names and trademarks are the property of their respective owners.  

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Miglustat (Zavesca) Approved

Apr 21,2022

Breckenridge Announces Approval of its ANDA for Miglustat Capsules (generic for Zavesca®)

Berlin, Connecticut, April 21, 2022

Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Miglustat Capsules (generic for Zavesca®), 100mg strength.  The product will be will be commercialized from a USA-based manufacturer.  Breckenridge plans to launch Miglustat Capsules during the third quarter of 2022 and the product will be offered in a 90-count bottle.   According to industry sales data, Zavesca and its generics had annual sales of $15 million during the twelve months ending February 2022.

About Breckenridge:

Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical (Osaka, Japan), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients.  With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and quality of life of the patients we and our customers serve.

www.bpirx.com

For further information, please contact:

Breckenridge Pharmaceutical, Inc.

Robert Gasparino, Associate Vice President – Business Development

Tel: 860-828-8140

E-mail: rgasparino@bpirx.com

 

*All brand names and trademarks are the property of their respective owners.

Read More >>

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All brand names are registered trademarks of their respective owner(s).