Spain Europe
FDF / DRUG PRODUCTS COSMETICS in Europe
FELTOR
About the plant
LABORATORIS FELTOR, ANJAC Health & Beauty Group, is a CDMO specialized in the manufacture and development of cosmetics,health products, insect repellents, anti-lice / head lice treatments and medical devices.
We are commited to service, safety, innovation and quality.
We are FDA audited and we comply with the strictest of GMP and ISO quality standards to ensure the overall safety.
Compliance
- ISO
- FDA (cGMP)
- ECOVADIS
- World Health Organization (GMP / HACCP)
- 9001
- 13485 (Medical devices)
- 22716 (Cosmetics)
Activity
- Inhalation products, Oral liquids and semisolids, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Aerosol, Bottles, Tubes, Sprays, Bulk, Sachets, Stick packs, Oral solutions, Oral emulsions, Oral gels, Terminal sterilization, Fill&Finish, Dropper bottles, Ophtalmic dispensers, Liquid forms, FDF / DRUG PRODUCTS, COSMETICS, Skin products, Hair and scalp care products, Products for nails and cuticles, Oral hygiene products, Skin care, Skin cleansing, Hair bleaching, Correction of body odor or perspiration, Shaving, pre-shave and after-shave, Make-up, Sun protection and self-tanning, Other skin care products, Hair and scalp care and cleansing, Hair styling, Other hair and scalp care products, Nail care and hardening, Other nail and cuticle products, Hygiene , Mouthwashes or mouth sprays, Cream / paste, Liquid, Spray, Others, Foam manufacturing
Features
- Uses: Investigational, Human, Veterinary
- Toxicity (OEB classification): 3 (PDE = 100 - 1,000 µg/day)
- Controlled substance: High potential for abuse & no medical use
- BSL: N/A
- Therapeutic areas: (D) Dermatologicals, (P) Antiparasitic products, insecticides and repellents
- Markets: FDA (USA)
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, Tech transfer, Pilot plant, Formulation mixing, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, CMC regulatory support, IND (Investigational New Drug application) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission, Orphan Drug Designation Support, Safety studies, Efficacy studies, Samples manufacturing, Extractables & Leachables, Stability tests, Identity, Content, Purity / Potency, Impurities, Physicochemical characterization, Water content (KF), Particle size (LD), Crystal form, Residual solvents (GC-MS), Elemental impurities / Metals (ICP-MS), Nitrosamines (HPLC-MS/MS), Endotoxins (LAL), Microbiology, Medical Cannabis, Drug Product – Liquid
