Piramal Pharma Solutions and George Medicines Achieve FDA Approval for WIDAPLIK, the First Triple Combination Hypertension Therapy

29 August 2025 | Friday | News

Developed through a strategic CDMO partnership, WIDAPLIK combines telmisartan, amlodipine, and indapamide in a single pill—marking a paradigm shift in initial hypertension treatment with multiple dose options and an established safety profile.

  • Piramal Pharma Solutions extended its robust CDMO capabilities to George Medicines to develop WIDAPLIK.
  • WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
  • WIDAPLIK contains three medicines that are clinically proven to reduce blood pressure: telmisartan, amlodipine, and indapamide.

 George Medicines, a leading late-stage biopharma company, in partnership with Piramal Pharma Solutions (PPS), a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd. (NSE: PPLPHARMA) (BSE: 543635) developed WIDAPLIK, a new drug for treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure. The U.S. Food and Drug Administration (FDA) approved WIDAPLIK on June 6, 2025.

WIDAPLIK is a single pill combination of three medicines, telmisartan, amlodipine, and indapamide, for the treatment of hypertension, developed in three doses (10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg strengths), including two doses that are lower than those currently available in single pill combinations. It is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Its multi-mechanism approach and available doses are formulated to deliver the blood pressure-lowering benefits of a triple combination therapy early in the treatment pathway, with the established safety profile of its three component antihypertensive medications.

WIDAPLIK carries a Boxed Warning for fetal toxicity and should be discontinued as soon as pregnancy is detected. Please see full Prescribing Information and Important Safety Information, including Boxed Warning for WIDAPLIK here.

George Medicines and Piramal Pharma Solutions began their collaboration on WIDAPLIK in December 2018, when the formulation was developed at Piramal's Pharmaceutical Development site in Ahmedabad, India. In June 2020, the project was transferred to Piramal's drug product facility in Pithampur, India for validation and manufacturing. Leveraging Piramal's vast technical expertise and extensive experience advancing innovations, George Medicines achieved FDA approval for WIDAPLIK this year.

The success of this endeavor underscores the advantages of Piramal's integrated approach to drug development. By leveraging the expertise and specialized capabilities of each facility involved in the project, Piramal Pharma Solutions and George Medicines developed WIDAPLIK with remarkable efficiency. This accomplishment will help enable patients worldwide to access this new treatment, furthering Piramal Pharma Solutions' mission to reduce the global burden of disease.

"This achievement highlights the value that Piramal Pharma Solutions delivers to its clients and the patients they serve," said Peter DeYoung, CEO, Piramal Global Pharma. "We are excited to deepen our collaboration with George Medicines, expanding access to transformative treatment options like WIDAPLIK to support our mission and enhance patient outcomes on a global scale."

"Our strategic partnership with Piramal Pharma Solutions has been an important part of the success to date of WIDAPLIK," added Mark Mallon, CEO, George Medicines. "Globally, more than one billion adults have hypertension, and it remains a major cause of premature death worldwide. With its triple combination efficacy, multiple dosing options, including two doses that are lower than those currently available in single pill combinations, and its established safety profile, WIDAPLIK has the potential to change the hypertension treatment paradigm. Piramal Pharma Solutions is an excellent development and manufacturing partner on this program who brings capacity, know-how, and shares our commitment to affordability, access, and quality, and we look forward to the continuation of our strong partnership."

Piramal Pharma Solutions is immensely proud to have contributed to George Medicines' milestone achievement and looks forward to continued success with its partners, aiming to deliver more treatment to patients in need worldwide.

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