Portugal Europe
FDF / DRUG PRODUCTS in Europe
Sidefarma is a CMO specialized in the manufacture of small and medium size batches for pharmaceutical companies across the world in regulated markets following European quality.
About the plant
SIDEFARMA is a CMO based in Portugal, specialized in the manufacture of differentiated and customized size batches of solid (coated tablets, tablets, capsules and powder sachets), semi-solid (creams, ointments, gels and suppositories) and liquid (syrups and solutions) dosage forms. Always accompanying the progress and trends of the Pharmaceutical Industry, SIDEFARMA relies on more than 45 years of technological experience and is continuously reinforcing its production capacities.
We are specialized in the manufacturing of small to medium scale batches.
Compliance
- ISO
- EMA (EU GMP)
- UAE Ministry of Health & Prevention
- 9001
- 14001
Activity
- Oral liquids and semisolids, Oral solids / OSD, Topical, mucosal and transdermal, Bottles, Tubes, Sprays, Oral solutions, Oral suspensions, Oral emulsions, Syrups, Oral gels, Tablets, Hard capsules, Granules / Pellets, Powders, Semisolid forms, Liquid forms, 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)
- Controlled substance: High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
- BSL: N/A
- Therapeutic areas: N/A
- Markets: DIGEMID (Peru), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), EDE (UAE), SFDA (Saudi Arabia), Turkish Health Authorities
Batch Size / Reactor
- Small, Medium
Services
- Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Tech transfer, Pilot plant, Formulation mixing, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization
