Frequently Asked Questions
What is an API?
API is an abbreviation for Active Pharmaceutical Ingredient, the main ingredient in a medicine that causes the desired effect of the medicine. Some medicines contain more than one API that act in different ways in the body. APIs may also be referred to as drug substances or pharmacologic substances.
What is CGMP compliance?
CGMP stands for Current Good Manufacturing Practice, a set of regulations that ensures the safety, quality, and consistency of pharmaceuticals. CGMP guidelines include qualification, validation, and documentation.
Why is CGMP compliance important?
CGMP compliance ensures the safety, quality, and consistency of pharmaceuticals. It is critical for meeting regulatory requirements for pharmaceuticals. They guarantee the identity, strength, and purity of drugs, protecting consumer health and ensuring product efficacy.
What are CEPs and DMFs?
CEP stands for ‘Certification of suitability to the monographs of the European Pharmacopoeia’. DMF stands for Drug Master File. A DMF is a submission to the US Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
Do you have CEPs on file?
Cayman Chemical has one CEP for Latanoprost.
What carriers are used to transport finished CGMP/API products?
Cayman utilizes prequalified global transportation service providers that meet stringent standards for the safe and secure delivery of our finished CGMP/API products. While we have relationships with preferred carriers, other transportation organizations can be contacted, upon request, to meet specific logistical needs or preferences by our clients.
Can Cayman manufacture my custom product under CGMP standards?
We have over 40 years of experience and extensive proficiencies in performing multi-step organic syntheses for complex molecules. Visit our Custom CGMP Development & Manufacturing page for more information or to submit an inquiry.
Are your facilities inspected by the US DEA?
Cayman Chemical is routinely inspected by the US-DEA and fully licensed for the manufacturing, importing, and exporting of DEA Schedule I-V controlled substances.
Does Cayman manufacture prescription or over-the-counter products?
Cayman Chemical and Cayman Pharma manufacture Active Pharmaceutical Ingredients (APIs) for use in pharmaceutical products. We do not manufacture, sell, or distribute any over the counter (OTC) or prescription products under either of our brands. If you come across a product using Cayman Chemical or Cayman Pharma branding, please notify us by emailing
GMP-API@caymanchem.com.
Is it possible to obtain a Safety Data Sheet (SDS) in languages other than English?
We can prepare SDSs in many languages other than English with the assistance of computer software. Please contact our
Technical Support scientists with the item number and your language of choice for further assistance. Please note that some static parts of the SDS may still be in English. This is unavoidable.
Do you have DMFs on file?
Yes. Both Cayman Chemical and Cayman Pharma have product DMF’s on file. Please consult with our API staff for specifics in your region.
Have any of your products been cited in a finished formulated product?
To date, Latanoprost, Epoprostenol, Bimatoprost, Cloprostenol and Travoprost have been cited in finished products.
Have your facilities been audited?
Both Cayman Chemical and Cayman Pharma have been audited by government, pharmaceutical, and independent third parties.
Are your facilities ISO Certified?
Cayman Pharma is ISO 9001, ISO 14001, and OHSAS 18001. The Forensic Division at Cayman Chemical has ISO products that are accredited by ANAB in both ISO/IEC 17025:2017 and ISO 17034:2016 standards.
Are your facilities CGMP Certified?
Cayman maintains CGMP-dedicated space within their facilities for the manufacture of Active Pharmaceutical Ingredients.
Are your facilities inspected by the EU?
Cayman Pharma is routinely inspected by the European Medicines Agency while Cayman Chemical is waiting for a site inspection.
Are your facilities inspected by the US FDA?
Both Cayman Chemical and Cayman Pharma are routinely inspected by the US FDA.