API Solutions
Vitamin B12
Vitamin B12, or cobalamin, fuels some of the body’s most essential processes, including DNA synthesis, red blood cell production, and nervous system regulation.
Its production is based on a complex fermentation process that was developed by EUROAPI as early as 1966.
As the pharmaceutical industry’s sole Western manufacturer of vitamin B12, EUROAPI plays a crucial role in ensuring its global supply.
Production site
Equipped with decades-long expertise in biotech manufacturing, EUROAPI continues to produce all its vitamin B12 at its site in St-Aubin-lès-Elbeuf, France.
This SEVESO site is audited and approved by the FDA, ANSM, RUSSIA, FAMI-QS and DDPP, and is certified Halal and Kosher.
It is also ISO50001 certified.
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 regulatory and quality track records [no critical remarks]
- 110+ successful on-site client audits between 2018-2020(3)
(1) Except our Haverhill site which is certified by the MHA
(2) Except Elbeuf which has not been inspected
(3) No audits have 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.
