03.29.23
Piramal Pharma Solutions, a CDMO and part of Piramal Pharma Ltd., has completed the successful integrated development and manufacturing of drug substance and drug product for Brenzavvy (bexagliflozin), TheracosBio’s recently approved treatment for type 2 diabetes.
The U.S. FDA approved Brenzavvy, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, in January 2023. The FDA approval is based on results from a clinical program that evaluated the safety and efficacy of Brenzavvy in 23 clinical trials enrolling more than 5,000 particpants.
Piramal Pharma Solutions and TheracosBio initiated the bexagliflozin partnership at Piramal’s Ahmedabad, India site, where the manufacturing process for the tablet form was first established. The project then shifted to the Morpeth, UK site for manufacture of the pill. Piramal’s site in Ennore, India then produced the regulatory starting materials and its Digwal, India site is producing the active pharmaceutical ingredient (API).
“The recent FDA approval represents a significant milestone for TheracosBio and provides an important treatment option to patients who suffer from type 2 diabetes. We are extremely pleased with the work the Piramal team has done to help make the approval possible,” said Albert R. Collinson, Ph.D., President and CEO of TheracosBio. “During the course of this program, we have developed an extensive relationship with Piramal. Working with different managers in different countries on various elements of the manufacturing process has turned out well.”
According to Peter DeYoung, Chief Executive Officer, Piramal Global Pharma, “Our partnership with TheracosBio is an important example of how an integrated services offering can benefit a client. This program has been extensive, crossing continents over years of development. We’re pleased that we’ve been able to support their needs every step of the way. We are very proud of the work we have done and we congratulate TheracosBio on reaching this important milestone.”
The U.S. FDA approved Brenzavvy, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, in January 2023. The FDA approval is based on results from a clinical program that evaluated the safety and efficacy of Brenzavvy in 23 clinical trials enrolling more than 5,000 particpants.
Piramal Pharma Solutions and TheracosBio initiated the bexagliflozin partnership at Piramal’s Ahmedabad, India site, where the manufacturing process for the tablet form was first established. The project then shifted to the Morpeth, UK site for manufacture of the pill. Piramal’s site in Ennore, India then produced the regulatory starting materials and its Digwal, India site is producing the active pharmaceutical ingredient (API).
“The recent FDA approval represents a significant milestone for TheracosBio and provides an important treatment option to patients who suffer from type 2 diabetes. We are extremely pleased with the work the Piramal team has done to help make the approval possible,” said Albert R. Collinson, Ph.D., President and CEO of TheracosBio. “During the course of this program, we have developed an extensive relationship with Piramal. Working with different managers in different countries on various elements of the manufacturing process has turned out well.”
According to Peter DeYoung, Chief Executive Officer, Piramal Global Pharma, “Our partnership with TheracosBio is an important example of how an integrated services offering can benefit a client. This program has been extensive, crossing continents over years of development. We’re pleased that we’ve been able to support their needs every step of the way. We are very proud of the work we have done and we congratulate TheracosBio on reaching this important milestone.”
