Special Drug Formulation Facility with advanced Equipment

Special Formulation Capabilities

We routinely specialize in formulating highly toxic compounds, such as cytotoxic, hormones, potent substances, controlled substances and steroids into safe and effective oral solids, liquid or lyophilized drug products.

Formulation Services

BROCHURE

Featured Services

Advanced Hormone API Production Facility

Piramal&rsquos facilities and skilled team of experts can help you safely and efficiently turn your high-potency project into a success. We specialize in formulating highly toxic compounds, such as cytotoxics, hormones, potent substances, controlled substances and steroids into oral solids, liquid or lyophilized drug products.

With a client base that includes large and small pharma, biotechs, animal health, academic and government institutions, Lexington has expertise to support manufacturing from pre-clinical to commercial manufacturing for high potent injectables, while our formulations facility at Sellersville has expertise in manufacturing potent oral solids and handling controlled substances.

Salient features

State-of-the-art mobile isolator technology in the manufacturing facility to provide Class A environment a physical barrier against toxic substances
Fixed isolators used in development labs to mimic manufacturing operations and enable formulation and analytical development
Use of glove boxes to maintain a controlled sterile envelope enabling handling of potent drug classes
We can assist clients with hazard evaluation of their compounds by determining the Occupation Exposure Limit (OEL)
All direct product contact equipment is either dedicated or disposable in order to provide robust protection against cross-contamination

Our Morpeth facility has over 40 years of experience in the development of oral contraceptive pills, hormone replacement therapies and a wide range of hormonal APIs. The site is equipped with a dedicated hormonal manufacturing suite and packaging capabilities for safe handling and containment of hormonal products.

Salient Features

Capacity to package up to 1.3 billion tablets and capsules annually
Ability to support ANDA development
Extensive capability to package multi-phasic products
Staff in development, manufacturing, packaging and QC have worked on multiple development and transfer projects