Active Pharmaceutical Ingredients (APIs)
Azelis Pharma offers active pharmaceutical ingredients (APIs), for pharma, medical and veterinary applications. Unrivalled sourcing from reputable manufacturers worldwide, combined with our market knowledge, provides products and value-added services and solutions for customers’ current and future needs. We offer a reliable integrated supply chain with first-class logistics support across Europe, Canada and Asia.
Our strength is in our dedicated team’s expertise in sourcing and supply – from targeting value-added ingredients and product groups, manufacturer assessments, product evaluation and regulatory compliance, to specialist storage, packing and delivery, tailored to customers’ logistical and pricing needs.
Our GMP/GTDP-certified sites are licensed to import and distribute APIs under the Falsified Medicines Directive. Our qualification procedures for every substance include assessment of manufacturers’ GMP, quality and regulatory documentation. Of additional value to customers and principals are our facilities for GMP repacking of APIs (class D clean room under laminar flow), excipient liquids and narcotics.
Our highly professional?regulatory affairs team?can help with:
- Registrations and registration dossiers, own and third party
- Certificates of European Pharmacopoeia (CEPs),
- Evaluation and registration of Active Substance Master Files (ASMFs),
- GMP implementation, upgrades and audits.
We also hold licenses for the import/export and supply of medicinal product intermediates (e.g. granules for direct tablet compression), drug precursors, narcotics and controlled drug substances with specially-secured stores at several sites.
Online product catalogue!
The online product catalogue is?temporarily unavailable.
We are currently optimising this section of the website to better cater to your needs. However, if you wish to request samples or need access to specific product information, MSDS or formulations, please refer to your?local contact.?We apologise for the inconvenience.
Alternatively, here is a list of?some of our therapeutic areas and key API products:
|Key API products?||?|
|Fusidic acid||Paroxetine HCl anhydrous|