Active Pharmaceutical Ingredients
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.
The Azelis Regulatory Affairs team, including in-house Qualified Person, 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.
Browse more information about our APIs below:
Alternatively here are some of our therapeutic areas and key API products. Please contact your local office for more information.
|Key API products:|
|Clindamycine HC1||Doxycycline hyclate|
|Doxycycline monohydrate||Enalapril maleate|
|Fusidic acid||Paroxetine HCl anhydrous|
|Phenylbutazone||Torsemide Form I|