Piramal Pharma Solutions
MUMBAI, India, March 31, 2023 (Reuters) /PRNewswire/
- TheracosBio recently received FDA approval for Brenzavvy™ (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor.
- Piramal supported TheracosBio with starting materials, active pharmaceutical ingredients (API) and oral solid dosage formulations
- Integrated drug development and manufacturing program involving multiple Piramal sites in India and Europe
Piramal Pharma Solutions, a patient-focused Contract Development Company and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd (PPL), (NSE: PPLPHARMA) (BSE: 543635), announced today that the Company has integrated the development and manufacturing of the active ingredient and of the drug for BRENZAVVY™ (bexagliflozin), the type 2 diabetes drug recently approved by TheracosBio.
US Food and Drug Administration (FDA)-approved Brenzavvy, an oral sodium-glucose cotransporter-2 (SGLT2) inhibitor, approved in January 2023. The FDA approval is based on the results of a clinical program that evaluated the safety and efficacy of Brenzavvy in 23 clinical trials involving more than 5,000 participants.
Piramal Pharma Solutions and TheracosBio started their bexagliflozin partnership at Piramal’s site in Ahmedabad, India, where the manufacturing process for the tablet form was first established. Next, the project moved to the Morpeth, UK site to manufacture the actual pill. The relationship grew from there, with Piramal’s site in Ennore, India producing the regulatory starting materials and its site in Digwal, India producing the active pharmaceutical ingredient (API).
“The recent FDA approval represents a significant milestone for TheracosBio and offers an important treatment option for patients suffering from type 2 diabetes. We are very pleased with the work the Piramal team has done to facilitate approval,” said Albert R. Collinson, Ph.D., President and CEO of TheracosBio. “We have an extensive relationship throughout this program set up with Piramal. Working with different managers in different countries on different elements of the manufacturing process has proven to be worthwhile.”
Peter DeYoung, Chief Executive Officer of Piramal Global Pharma, said, “Our partnership with TheracosBio is an important example of how an integrated service offering can benefit a customer. This program was extensive and spanned several continents over the years. We are glad that we were able to support your needs every step of the way. We are very proud of the work we have done and congratulate TheracosBio on reaching this important milestone.”
About Piramal Pharma Solutions:
Piramal Pharma Solutions (PPS) is a Contract Development Company and Manufacturing Organization (CDMO) providing end-to-end development and manufacturing solutions across the drug lifecycle. We serve our customers through a globally integrated network of locations in North America, Europe and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. We also offer specialized services such as development and manufacturing of high-potency APIs, antibody-drug conjugates, sterile fill/finish, peptide products and services, and potent solid oral medicines. PPS also provides development and manufacturing services for biologics including vaccines, gene therapy and monoclonal antibodies made possible by Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a reliable service provider with experience in various technologies makes us a preferred partner for innovative and generic companies worldwide.
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 end-to-end manufacturing capabilities in 17 global facilities and a global distribution network in more than 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated contract development and manufacturing company, Piramal Critical Care (PCC), a complex hospital generics business, and the Indian Consumer Healthcare business, which sells over-the-counter products. In addition, PPL has a joint venture with Allergan, a leader in ophthalmology in the Indian formulation market, and a minority stake 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 intends to undertake a rights offering of its shares in the near future subject to the receipt of necessary approvals, market conditions and other considerations and has submitted a draft offer letter to the Securities and Exchange Board of India.
Photo: https://mma.prnewswire.com/media/2044051/Albert_R_Collinson.jpg
Photo: https://mma.prnewswire.com/media/2044054/Peter_DeYoung.jpg
Logo: https://mma.prnewswire.com/media/1726186/3963687/Piramal_Pharma_Solutions_Logo.jpg
View original content: https://www.prnewswire.com/news-releases/piramal-pharma-solutions-unterstutzt-theracosbio-mit-integriertem-arzneimittel-arzneimittelproduktprogramm-fur-bexagliflozin-301786759.html
Press contact:
Rajiv Banerjee,
Group Head – Corporate Communications,
[email protected],
+91-9920454102; For investors: Gagan Borana,
General Manager – Investor Relations&Sustainability,
[email protected]
Original content from: Piramal Pharma Solutions, transmitted by news aktuell