Few decisions in pharmaceutical operations are as critical as selecting the right cGMP Contract Manufacturer for your company's Active Pharmaceutical Ingredient (API). APIs manufactured to cGMP standards for commercial sale must meet stringent requirements for identity, strength, quality and purity.
CordenPharma’s understanding of the development process, and access to resources throughout its network of facilities, allows for the fast and reliable supply of APIs. We provide seamless technology transfer from research laboratories to our integrated network of reliable commercial cGMP manufacturing facilities, which offer a wide range of reactor capacity (25 L - 28,000 L).
Our R&D department has a proven track record in preparing small quantities of your target compound. Since the initial synthesis may not be suitable to prepare larger quantities, we adapt to expanding requirements by adopting a synthesis that will best suit your needs.
If you already have a demonstrated route and need it reproduced in a timely and efficient manner, CordenPharma surpasses expectations by identifying and developing appropriate steps for scale-up and safety considerations.
CordenPharma’s customers benefit from extensive infrastructure with proven experience in producing commercial products that are distributed into worldwide regulated markets:
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Reactor pools with wide ranging flexibility in size (25-28,000 L), media compatibility (Hastelloy; glass-lined, steel) and temperature (-100°C to +200°C)>>
Over 1,250,000 L volumetric Total Reactor Capacity>>
Multiple product isolation technologies (centrifuge, filters, lyophilizer) with wide material compatibility (Hastelloy; stainless steel)>>
Multiple drying options (agitated and static dryers)>>
Multiple powder handling & finishing capabilities including sieving, blending & milling>>
Handling of Highly Potent compounds down to exposure limits of 1ng/m3Want more information on Custom API Manufacturing? Click the link below to contact us.