Laboratorio REIG JOFRE, SA (BARCELONA PLANT)

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)

Injectable (lyo and liquid) and Liquid manufacturing facilities

About the plant

Barcelona Plant can develop and manufacture (FDF):

• Sterile liquids in glass vials (aseptic filling)
• Sterile lyophilizates in glass vials (aseptic filling and freeze-drying)
• Non-sterile liquid medicines

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Certifications

• EMA (EU GMP)
• Health Canada (Canada GMP)
• ECOVADIS
• World Health Organization (GMP / HACCP)
• ANVISA (Brazil B-GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• ISP (Chile BPM)
• INVIMA
• MHRA (UK GMP)

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Activity

• Oral liquids and semisolids, Topical, mucosal and transdermal, Injectables, Bottles, Oral solutions, Oral suspensions, Liquid forms, Fill&Finish, Small volume vials, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• 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)
• DEA: Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL: 1, 2, 3
• Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system
• Markets: INVIMA (Colombia), ISP (Chile), EMA (EU), PMDA (Japan), MHRA (UK), TGA (Australia), ANVISA (Brazil), MFDS (South Korea)

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Batch Size / Reactor

• Medium, Large

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, 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, Primary packaging, Secondary packaging, Labeling, Serialization, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support

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