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PHARMALOOP S.L. - a Salvat Company
Laboratorios Salvat
Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, capsules and tablets.
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
COMPLIANCE: EMA (EU GMP), FDA (cGMP), ISO
REGION: Europe
USE: Human
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
MARKETS: FDA (USA), EMA (EU)
THERAPEUTIC AREAS OF EXPERTISE (ATC): (V01) Allergens, (S) Sensory organs, (A) Digestive tract and metabolism
BSL (Biological Safety Level): 1
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
REGION: Europe
BSL (Biological Safety Level): 3, 1, 2
USE: Human, Veterinary
THERAPEUTIC AREAS OF EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (P) Antiparasitic products, insecticides and repellents
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
SERVICES: Manufacturing services, Regulatory services, Development services
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
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Location available after registration
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Desarrollador y fabricante de nuevos medicamentos con tecnologías de liberación controlada.
Location available after registration
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Demo facility
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How MAI CDMO Network Works
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Key Benefits of Partnering with a CMO/CDMO
- Accelerated Time-to-Market: Leverage the expertise and resources of a CMO/CDMO to expedite your drug development process.
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Featured Services
- API Manufacturing: Source high-quality active pharmaceutical ingredients from experienced manufacturers.
- Clinical Trial Supplies: Secure reliable and compliant supplies for your clinical trials.
- Fill-Finish and Packaging: Partner with experts in sterile filling, lyophilization, and packaging to ensure product stability and patient safety.
- Analytical Testing: Access a wide range of analytical services to support your drug development program.
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