API Solutions
Opiates & Controlled Substances
EUROAPI is a leading manufacturer of alkaloid APIs (narcotics and non narcotics).
We provide pharmaceutical companies with secure, compliant, and high-quality opiate APIs, combining agricultural expertise, industrial excellence, and supply chain control.
Thanks to the full integration of our value chain and our large-scale manufacturing capacities, we can fulfill our customers’ needs all year long.
EUROAPI can meet pharma companies’ requirements for opiate APIs combining proven expertise, quality and reliability:
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A trusted partner to secure opiate APIs supply
Our vertically integrated supply chain in France, from poppy cultivation through Narcotics Raw Materials (NRMs) to high-purity APIs, ensures a stable and reliable supply of opiate APIs. Our large-scale manufacturing capacities can also fulfill high demand. This unique model provides our customers with strategic autonomy and long-term supply reliability.
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Consistent quality and global regulatory footprint
All our APIs and Intermediates meet the latest regulatory and quality requirements through active monitoring and a reliable, high-performance supply chain. Our regulatory expertise spans across Europe, the USA, China and Japan.
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Environmental sustainability embedded across our operations
We are committed to improving our environmental footprint and integrates sustainability at every step of our API production:
o Low water consumption during poppy cultivation thanks to favorable climatic conditions in France
o Solvent recovery: >90% are recovered during extraction and manufacturing processes
o Recycling of by-products
Our latest Life Cycle Assessment (LCA) study shows low carbon footprint for our main opiate APIs. Our team is pleased to share with you the latest data on our carbon score upon request.
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To secure your opiate API supply
EUROAPI holds a broad portfolio of opiates APIs spanning various therapeutic areas :
APIs for pain management (narcotics)
Expert in the manufacturing and management of narcotics (Schedule II and III), EUROAPI is a premium partner of pharmaceutical companies to provide essential medicines for mid to severe pain.
| CAS Number | Regulatory documentation | |
|---|---|---|
| Codeine Phosphate |
41444-62-6 |
CEP |
| Codeine Base | 6059-47-8 | CEP |
| Codeine Camphosulfonate | 1360181-44-7 | EU-ASMF |
| Ethylmorphine HCL | 6746-59-4 | CEP |
| Morphine HCl | 6055-05-7 | CEP |
| Morphine Sulphate | 6211-15-0 | CEP |
| Nalbuphine HCl* | 23277-43-2 | EU-ASMF, US-DMF, C-DMF, TW-DMF, CEP, ca-DMF, C-DMF |
| Oxycodone HCl | 124-90-3 | CEP, Ca-DMF, C-DMF |
* Nalbuphine is considered as narcotic only in certain territories
Products for addiction and other treatments
We provide safe, effective and high-quality therapeutic solutions for addiction, alcohol dependency, Central Nervous System (Parkinson disease) and cold & cough treatments.
| CAS number | Regulatory documentation | |
|---|---|---|
| Apomorphine HCl | 41372-20-7 | CEP, US-DMF |
| Naloxone HCl | 51484-60-8 | CEP, US-DMF, Japan-DMF, C-DMF, Ca-DMF, K-DMF |
| Naltrexone HCl | 16676-29-2 | CEP, US-DMF, C-DMF, Ca-DMF, K-DMF |
| Noscapine | 128-62-1 | Submission on-going |
EUROAPI offers a portfolio of narcotic raw materials (NRMs) and intermediates:
| CAS numbers | |
|---|---|
| Concentrated poppy straw (CPS) Morphine | 57-27-2 |
| Concentrated poppy straw (CPS) Thebaine | 115-37-7 |
| Concentrated poppy straw (CPS) Noscapine | 128-32-1 |
| Noroxymorphone HCl | 33522-95-1 |
For more information about our products
Production Site
EUROAPI through its subsidiary Francopia acts as manufacturer/distributor for its entire opiate and opioid API portfolio, which is manufactured at a Sanofi dedicated site using a continuous extraction process. With 20-30 quality audits each year, this site is regularly inspected by international authorities such as the FDA, MFDS, PMDA, ANVISA, and Tr MOH.
Quality
EUROAPI provides you with active ingredients that meet the highest pharmaceutical standards.
At EUROAPI, we are constantly reinventing both ourselves and our technologies to meet your evolving needs.
Wherever in Europe your product is developed and manufactured, all our offerings meet the latest regulatory and quality requirements through active monitoring and a reliable, high-performance supply chain.
Our geographical coverage includes large countries such as China and Russia. We also have local regulatory expertise across Europe, the U.S. and Japan.
Our industrial sites are certified by the EMA(1), FDA and PMDA(2) , and we operate in full compliance with GMP standards.
- All our sites inspected by the FDA (US) and EMA (EU) enjoy outstanding quality and regulatory track records [no critical remarks]
- 110+ successful on-site client audits between 2018-2020(3)
(1) Except the Haverhill site which is certified by the MHA
(2) Except Elbeuf which has not been inspected
(3) No audit led to client loss
Premium Customer Service
EUROAPI supports your business by delivering tailored solutions and a long-term partnership approach that ensure constant peace of mind.
- We listen to and work closely with you in a fully integrated way, offering you customized solutions.
- Our strength lies in the diversity of our people and expertise. Dedicated team members assist you at every step of your project, from process development to market authorization, and throughout your product’s lifecycle.
- We can help you ensure successful product launches and growth in markets worldwide through our network spanning 80+ countries.
