FDF / DRUG PRODUCTS in Europe
Specialized CDMO for development and production of small molecules injectables.
About the plant
Tailored CDMO Solutions for small molecules injectables
EVER Pharma combines over 60 years of experience in sterile productlion with innovative expertise and cutting-edge manufacturing technology. The Company produces high-quality complex injectables - including high-potency and controlled substances, crystalline suspensions, and oily Solutions - across vials, pre-filled syringes, cartridges, implants, and ampoules. These productions serve both EVER Pharma´s global portfolio and third-party clients.
Founded as Jenapharm in 1950, the site has seen extensive investments. In 2011 the site became EVER Pharma Jena GmbH following acquisition by EVER Pharma Austria. As part of its expansion, EVER Pharma invested over €200 Million in state-of-the-art manufacturing facilities, which were commissioned in 2021.
EVER´s expertise includes technology transfer, formulation development and scalable manufacturing. The state-of-the-art-facilities in Austria and Germany guarantee quality and efficiency, supporting your product from development to market launch. Let us Help you bring your innovations to life.
Compliance
- ISO
- EMA (EU GMP)
- NMPA (China GMP)
- ANVISA (Brazil B-GMP)
- Roszdravnadzor (Russia GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
- TITCK (Turkish Health Authorities)
- 14001
Activity
- Implants, Injectables, Terminal sterilization, Fill&Finish, Small volume vials, Large volume vials / Bottles, Glass ampoules, PFS (Prefilled Syringes), Cartridges, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Commercial (Phase IV), Human
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- Controlled substance: High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
- BSL: 1, 2
- Therapeutic areas: (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system
- Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Registration batches, Batch records
