Piramal Pharma Solutions, 650 Cathill Rd, Sellersville, PA 18960, USA
Our Sellersville, USA facility is a USFDA inspected and EMA certified, fully integrated site which offers product and process development, clinical supply and commercial manufacturing and packaging of solid oral dosage forms, liquids, creams, and ointments.
Our Sellersville facility has 50+ years of experience in drug product development and manufacturing. The site is capable of supporting early stage development through to the commercial stage for a number of dosage forms including oral solids, liquids, creams and ointments.
Potent compounds present a unique set of challenges and safety concerns. At Sellersville, we have an excellent track record in dealing with the complexities associated with potent formulations, from early development through to scale-up and commercial launches.
The Sellersville facility offers end-to-end drug product development, including packaging of the final drug product. Through our wide range of packaging services, we prioritize compliance with major regulatory authorities and directly enhance time-to-market for your drug.
The facility boasts of a state-of-the-art temperature controlled warehouse for storage of final dosage forms. We have a 1,260 sq. ft. refrigerated storage unit for temperature sensitive compounds and a 200+ pallet DEA Cage area for Class III-Class V compounds.
Our Sellersville facility has 50+ years of experience in drug product development and manufacturing. The site is capable of supporting early stage development through to the commercial stage for a number of dosage forms including oral solids, liquids, creams and ointments.
Potent compounds present a unique set of challenges and safety concerns. At Sellersville, we have an excellent track record in dealing with the complexities associated with potent formulations, from early development through to scale-up and commercial launches.
The Sellersville facility offers end-to-end drug product development, including packaging of the final drug product. Through our wide range of packaging services, we prioritize compliance with major regulatory authorities and directly enhance time-to-market for your drug.
The facility boasts of a state-of-the-art temperature controlled warehouse for storage of final dosage forms. We have a 1,260 sq. ft. refrigerated storage unit for temperature sensitive compounds and a 200+ pallet DEA Cage area for Class III-Class V compounds.
The Sellersville team is experienced in a variety of dosage technologies such as immediate release, modified release, orally disintegrating tablets, pediatric formulations and sublingual tablets. Our manufacturing capacity of 2.5 billion tablets/year and 1.4 billion capsules/year makes us well-equipped to support commercial launches.
We produce a range of liquid and semi-solid dosage forms like creams and ointments. Sellersville has 9 manufacturing suites for creams and ointments, and 8 manufacturing suites for liquids, including a potent suite for Category IV compounds.
The Sellersville facility has the capability for development, manufacture, packaging & distribution of highly potent formulations with OEL down to 1 ug/m3 and other controlled substances. We have successfully completed DEA general inspection in February 2022.
The Sellersville site features specialized equipment like high shear granulators, V-blenders and bin technologies for manufacturing OSDs, along with roller compaction, hot melt granulation, fluid bed technologies and low humidity process suites.
We have 3 solid dose packaging lines offering fully serialized and aggregated bottle packaging from 45cc to 1500cc HDPE bottles. The site also has 4 non-serialized LCO packaging lines for liquids, creams and ointments.
We have expertise in managing the entire product development cycle, from early-phase development to commercialization. Customers can greatly accelerate timelines and speed-to-market by leveraging other services in Piramal’s global integrated network.
Legacy of more than 50 years in handling oral solids, liquids, creams and ointments. Our rich experience helps us tackle all challenges at any stage of the drug development process.
We have implemented robust quality systems, including deviation investigation, self-inspection, documentation, and CAPA, to ensure stringent regulatory compliance and on-time delivery to our customers.
The Sellersville team has a demonstrated history of working with high potent formulations. We have also cleared DEA general inspection in February 2022, further highlighting our capability and compliance with regulatory agencies.
