GMP API Production

The Importance of Process Understanding

Over the past 10 years, “process understanding” has become the bylaw of Good Manufacturing Practice regulations, with good reason – quality can’t be designed into a product without knowing the effects of upstream reaction conditions on the final Active Pharmaceutical Ingredient.

When it comes to process understanding, no other manufacturer can match Cayman’s knowledge of prostaglandin chemistry. We are the experts in prostaglandin synthesis and we use this knowledge every day to synthesize eicosanoids and a wide variety of other non-GMP, research grade organic molecules. Our GMP development cadre of 9 Ph.D. chemists and their supporting staff has over 200 years of combined experience, allowing us to design, scale, and validate API manufacturing processes in accordance with the latest cGMP requirements, including ICH Q8, Q9 and Q10.

Commercial API production

We currently manufacture the following API’s and their early stage intermediates for commercial distribution. Contact our sales department for more information about pricing and availability.

Contract Manufacturing Services

In addition to our commercial API’s, we provide contract API manufacturing services. Our contract manufacturing services offer a number of advantages including:

• Chemists with “Big Pharma” experience who quickly share their discoveries and offer creative solutions in a way that only “Small Pharma” can
• In-house Custom Synthesis and Analytical Services departments to manufacture, purify, and characterize reference standards
• In-house manufacturing of all early intermediates, ensuring total control over quality and availability
• Credentialed Project Management and Quality Assurance professionals to ensure good communication and data-driven decision making
• Risk analysis, designed experiments, and other tools to maximize resource utilization and process understanding

We have successfully produced API’s for clinical trials and have the staff to generate timely and accurate documentation to assist our client’s regulatory filings from pre-IND through ANDA and NDA submissions. Contact us to learn about our competence, compliance, low cost and total commitment to customer satisfaction!

Facilities

Cayman produces API’s at FDA-registered facilities in Ann Arbor, Michigan and in Neratovice, just outside of Prague in the Czech Republic. The Ann Arbor facility specializes in the rapid development of manufacturing processes and analytical methods supporting clinical and small scale commercial supplies. The Prague facility specializes in all scales of commercial production and provides early intermediates for both facilities.

Other differences between the two sites are provided below. Whether you are interested in custom synthesis of new chemical entities or in any of our established API’s, Cayman can provide levels of quality, personalized service, and technical knowledge unmatched by any other company.