PHARMALOOP S.L. - a Salvat Company

PHARMALOOP S.L. - a Salvat Company

Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, capsules and tablets.

About the plant

Salvat has been developing, manufacturing and marketing innovative branded pharmaceutical products worldwide. Our strong capacity, expertise and innovative technology allow us to successfully deliver your product. Focused on ophthalmology, otorhinolaryngology, gastroenterology & consumer health care CDMO solutions. Salvat offers a fully integrated CDMO solutions for:

• Blow-Fill-Seal (BFS), with Rommelag technologies
• Sterile Multidose, with Groninger technologies
• Non-sterile Multi-dose
• Sachets, Capsules and tablets

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)

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Activity

• Inhalation products, Oral liquids and semisolids, Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Nebulization, Bottles, Sprays, Bulk, Ampoules, Oral solutions, Oral suspensions, Oral emulsions, Syrups, Tablets, Hard capsules, Granules / Pellets, Powders, Fill&Finish, BFS (Blow-Fill-Seal), BFS (Blow Fill Seal) ampoules, Bottles, Dropper bottles, Ophtalmic dispensers, Sprays, Semisolid forms, Liquid forms, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Commercial (Phase IV), Human
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
• DEA: N/A
• BSL: 1
• Therapeutic areas: (S) Sensory organs, (V01) Allergens
• Markets: FDA (USA), EMA (EU)

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Preformulation studies, Clean room rental, R&D, Formulation / Galenic design, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Engineering batches, Scale-up, Registration batches, Batch records, Clean room rental, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, CMC regulatory support

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