MUMBAI, India, March 31, 2023 /PRNewswire/ -- Piramal Pharma Solutions, a patient-focused Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd (PPL), (NSE: PPLPHARMA) ( BSE: 543635), today announced that the company has successfully completed integrated development and manufacturing of drug substance and drug product for Brenzavvy™ (bexagliflozin), TheracosBio's newly approved treatment for type 2 diabetes.
The US Food and Drug Administration (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 which evaluated the safety and efficacy of Brenzavvy in 23 clinical trials involving more than 5,000 people.
Piramal Pharma Solutions and TheracosBio began their collaboration on bexagliflozin at Piramal's facility in Ahmedabad, India, where the tablet manufacturing process was first established. The project then moved to Morpeth, UK to manufacture the tablet itself. The relationship grew from there, with Piramal's Ennore, India plant producing the regulatory starting materials and its Digwal, India plant producing the active pharmaceutical ingredient (API).
"The recent FDA approval represents a significant milestone for TheracosBio and provides an important treatment option for patients with type 2 diabetes. We are very pleased with the work done by the Piramal team to make the approval possible," he stated. Dr. Albert R. Collinson, President and CEO of TheracosBio. "Over 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 paid off."
As Peter DeYoung, CEO of Piramal Global Pharma, explained: "Our partnership with TheracosBio is an important example of how an integrated service offering can benefit a client. This program has been extensive, spanning continents over years of development. We are pleased that we were able to support your needs every step of the way. We are very proud of the work that has been done and congratulate TheracosBio on reaching this important milestone."
About Piramal Pharma Solutions:
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) that provides comprehensive development and manufacturing solutions throughout the drug life cycle. We serve our customers through an integrated global network of facilities in North America, Europe and Asia. This enables us to offer a wide range of services including drug discovery solutions, pharmaceutical and process development services, clinical trial supplies, commercial API supply and finished dosage forms. We also offer specialized services such as the development and manufacturing of highly potent active ingredients, antibody-drug conjugates, sterile fill/finish, peptide products and services, and potent solid oral drugs. PPS also provides development and manufacturing services for biologics, such as vaccines, gene therapies, and monoclonal antibodies, thanks to Piramal Pharma Limited's investment in Yapan Bio Private Limited. We believe that our track record as a trusted service provider with expertise in a variety of technologies makes us the preferred partner for off-the-shelf and innovative companies around the world.
For more information visit: www.piramalpharmasolutions.com | Facebook | Twitter | LinkedIn
About Piramal Pharma Ltd:
Piramal Pharma Limited (PPL), (NSE: PPLPHARMA) (BSE: 543635), offers a portfolio of differentiated products and services through comprehensive manufacturing capabilities at 17 global facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated contract development and manufacturing organization; Piramal Critical Care (PCC), a complex hospital generics business; and India's Consumer Healthcare business, which sells products without a prescription. In addition, PPL has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market, and a minority investment in Yapan Bio. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.
For more information visit: www.piramal.com/pharma | Facebook | Twitter | LinkedIn
Disclaimer:
Piramal Pharma Limited is proposing, subject to receipt of the necessary approvals, market conditions, and other considerations, a rights issue of its shares in the near future and has submitted a draft offer letter to the Board of Securities and Indian Stock Exchange.
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