Piramal CDMO begins solid oral dose production in the US

Published: 22-Jun-2020

PPS has entered into an agreement with G&W Laboratories to acquire its solid oral dosage drug product manufacturing facility located in Pennsylvania, US

Piramal Enterprise' Pharma Solutions business, a CDMO, has entered into an agreement with G&W Laboratories to acquire its solid oral dosage drug product manufacturing facility located in Sellersville, Pennsylvania, US.

The transaction closure is subject to customary pre-closing conditions. According to the terms of the agreement, PEL, through one of its affiliates, would acquire at closing a 100% stake in the entity that operates the facility and owns the related real estate.

This acquisition broadens the offering of Piramal Pharma Solutions (PPS) by adding solid oral dosage form capabilities (tablets and capsules) in North America.

Until now, PPS' capabilities in solid oral dosage forms were all located in the UK and India. The Sellersville site can also produce liquids, creams, and ointments, further expanding the PPS portfolio. The site also can support product and process development for solid oral dosage and oral liquids, including immediate release, modified release, chewable & sublingual solid oral dosage forms, solutions and suspensions in liquids. The site has received certifications from the FDA and EMA.

"Many of our customers are looking for US-based manufacturing partners to expand and support their pipeline. This acquisition strengthens our ability to partner with them on best-in-class drug products. It enhances our market-leading integrated services offering by adding a solid oral dosage capability in the US. We now offer solid oral drug product development and commercial manufacturing in all our major geographies, addressing a previously unmet customer need and strengthening our ability to work globally with customers to reduce the burden of disease on patients," said Peter DeYoung, CEO of Piramal Pharma Solutions

The Sellersville site covers 31.5 acres of land with over 221,000 sqft of manufacturing space, including 195,000sqft of GMP area. The site features dedicated manufacturing and packaging technologies for solid oral dosage forms, liquids, creams, and ointments; QC and microbiology labs; state-of-the-art preformulation and analytical development infrastructure coupled with a pilot lab for research and development; and a temperature-controlled warehouse.

The site currently has the necessary controls to support manufacturing of potent solid oral dosage forms. PPS intends to offer high potency drug manufacturing capabilities at the site, complementing the company's global strength in highly potent compounds. The site employs a highly knowledgeable and experienced workforce of ~100, with an average of 19 years of service with the site. PPS expects to further grow the site's current strength to support development services as well as any COVID-19 management drug opportunities.

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