柏林,康涅狄格州, 2022年8月1日

Breckenridge制药公司. 今天，美国宣布.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Cabazitaxel Intravenous Powder (generic for Jevtana Kit^®). This product was developed in collaboration with Natco Pharma Limited.  Breckenridge received final approval for the 60mg/1.5mL (40mg/mL)强度.   Breckenridge and Natco are unable to make further comment regarding the launch date for the product, as that is confidential and cannot be disclosed at this time.  根据行业销售数据, Jevtana Kit generated annual sales of $303 million during the twelve months ending May 2022. 

关于出台:

Breckenridge制药公司., a subsidiary of Towa Pharmaceutical (Osaka, 日本), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. 病人.  我们竭诚为客户服务, 准时交货, reliable supply and quality manufacturing, we strive to impact the health of the 病人 we and our customers serve.

huin4ck.cnit01.com

关于Natco:

Natco Pharma Limited is a global generic pharmaceutical research, 发展, 生产销售公司. The company was established in 1981 in India. Natco supplies pharmaceutical products to over 50 countries across the globe, 包括美国在内. Natco focuses on the 发展 and manufacturing of oncology and other specialty pharmaceuticals.

www.natcopharma.co.in

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

柏林,康涅狄格州, 2022年4月22日

Breckenridge制药公司. 今天，美国宣布.S. Food and Drug Administration has granted tentative approval of its Abbreviated New Drug Application for Dabigatran Etexilate Capsules (generic for Pradaxa^®). This product 发展 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.  根据行业销售数据, Pradaxa generated annual sales of $455 million during the twelve months ending February 2022. 

关于出台:

Breckenridge制药公司., a subsidiary of Towa Pharmaceutical (Osaka, 日本), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. 病人.  我们竭诚为客户服务, 准时交货, reliable supply and quality manufacturing, we improve the health and quality of life of the 病人 we and our customers serve.

huin4ck.cnit01.com

For further information, please contact:

Breckenridge制药公司.

Robert Gasparino, Associate Vice 总统 – 可靠的网赌平台

电话号码:860-828-8140

电子邮件: rgasparino@cnit01.com

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

Breckenridge Signs New-Product Agreement with PTS Pharma

柏林，康涅狄格州，2022年4月22日

Breckenridge制药公司. 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 发展 and commercialization will be performed at the Towa facility.  根据行业销售数据, 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.

关于出台:

Breckenridge制药公司., a subsidiary of Towa Pharmaceutical (Osaka, 日本), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. 病人.  我们竭诚为客户服务, 准时交货, reliable supply and quality manufacturing, we improve the health and quality of life of the 病人 we and our customers serve.

huin4ck.cnit01.com

关于PTS Pharma, LLC:

PTS咨询有限责任公司和PTS制药有限责任公司., 是一个公式开发, 临床试验生产, 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, 胶囊, 颗粒, 改良剂型, 外用剂型, 栓剂, 电影产品, 解决方案, 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, 一个行业资深人士谁是业主, 总统, 也是公司的首席执行官.

www.ptsglobalservices.com

For further information, please contact:

Breckenridge制药公司.

Robert Gasparino, Associate Vice 总统 – 可靠的网赌平台

电话号码:860-828-8140

电子邮件: rgasparino@cnit01.com

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