Piramal Pharma Solutions Announces Partnership with Botanix to Support Drug Substance Development

PRNewswire
Mumbai (Maharashtra) [India], May 18: Piramal Pharma Solutions (PPS), a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd. (NSE: PPLPHARMA) (BSE: 543635), has entered a manufacturing and supply arrangement with Botanix SB Inc., a subsidiary of Botanix Pharmaceuticals Limited (ABN 70 009 109 755) (ASX:BOT) ("Botanix"), a commercial dermatology company.
- Piramal Pharma Solutions has entered into an agreement with Botanix SB Inc., a subsidiary of Botanix Pharmaceuticals Limited, to support the development and commercial supply of Sofdra®.
- Sofdra is the first and only FDA-approved new chemical entity (NCE) for the treatment of primary axillary hyperhidrosis.
- Through this partnership, Piramal Pharma Solutions will leverage the strength of its North American drug substance facilities to support robust, consistent patient access to Sofdra.
Under this arrangement, PPS will initiate development and validation services for Sofpironium Bromide, the active pharmaceutical ingredient (API) in Sofdra®, at its Riverview, Michigan facility. Following successful regulatory approval at Riverview, PPS and Botanix will consider validating the process at PPS's Aurora, Canada facility. This potential twin-site strategy would give Botanix the option to use PPS as a dual-source commercial API supplier, enhancing its long-term supply chain flexibility and security.
With decades of combined experience, the Riverview and Aurora facilities offer exceptional proficiency in drug substance development and manufacturing, spanning R&D through commercialization. Recent investments have provided both facilities with the advanced equipment and unified systems required to execute this program, reinforcing the strengths of their geographic proximity and integration expertise while enhancing their ability to offer cost-efficient solutions.
By maintaining the option for development and validation at both sites, PPS can offer partners redundancy, supply chain continuity, and scheduling flexibility. If geopolitical issues arise, PPS can seamlessly shift production between facilities, ensuring ongoing supply for Botanix and its patients. This proactive approach enables PPS's partners to remain agile and resilient amid global uncertainty, with robust coverage across the US and the rest of the world.
These twin-site capabilities also offer financial benefits, enabling PPS's partners to better balance quality and time. By derisking the Sofdra supply chain, PPS is expected to provide Botanix a significant reduction in cost of goods sold.
"This business partnership demonstrates our ability to deliver tailored, resilient solutions for organizations like Botanix," said Peter DeYoung, CEO, Piramal Global Pharma. "Our North American drug substance facilities are equipped with the expertise, advanced technology, and cutting-edge capabilities required to help derisk the Sofdra supply chain and ensure this breakthrough therapy reaches patients in need with consistency and efficiency."
This phased approach will enable PPS to support future supply needs for Sofpironium Bromide while offering the potential for dual-site production if additional capacity is required. By proactively supporting supply chain continuity, PPS can help improve the quality of life for patients living with primary axillary hyperhidrosis, underscoring and reinforcing its commitment to Patient Centricity.
About Piramal Pharma Solutions
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities 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 the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products and services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines and gene therapies, made possible through Piramal Pharma Limited's associate company, Yapan Bio Private Limited.
For more information visit: Piramal Pharma Solutions | LinkedIn | Facebook | X
About Piramal Pharma Limited
Piramal Pharma Limited (PPL) (NSE: PPLPHARMA) (BSE: 543635), offers a portfolio of differentiated products and services through its 17* global development and manufacturing 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 the Piramal Consumer Healthcare business, selling over-the-counter consumer and wellness products. In addition, one of PPL's associate companies, Abbvie Therapeutics India Private Limited, a joint venture between Abbvie and PPL, has emerged as one of the market leaders in the ophthalmology therapy area in the Indian pharma market. Further, PPL has a strategic minority investment in Yapan Bio Private Limited, that operates in the biologics / bio-therapeutics and vaccine segments.
For more information, visit: Piramal Pharma | LinkedIn
* Includes one facility via PPL's minority investment in Yapan Bio.

About Botanix Pharmaceuticals
Botanix Pharmaceuticals Limited (ASX:BOT) is a dermatology company based in Philadelphia and Phoenix (US) which has received FDA approval for its lead product Sofdra™ for the treatment of primary axillary hyperhidrosis. Sofdra is the first and only new chemical entity approved by FDA to treat primary axillary hyperhidrosis and presents a novel, safe, and effective solution for patients who have lacked treatment options for this socially challenging medical condition.
To learn more please visit: https://botanixpharma.com/
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