Laboratorio REIG JOFRE, SA (TOLEDO PLANTS)

Laboratorio REIG JOFRE, SA (TOLEDO PLANTS)

Betalactam antibiotics (FDF) development and manufacturing state-of-the-art facilities.

About the plant

State-of-the-art facilities (2 separated plants), dedicated to Development and Manufacturing of Betalactam antibiotics (FDF). The Plants can develop and manufacture:

• Solid dosage forms (tablets, capsules, POS in sachets and POS in bottle), liquid oral form (syrup), glass vials filled with sterile powder (aseptic filling) for Penicillins
• Glass vials filled with sterile powder (aseptic filling) for Cephalosporins

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Certifications

• EMA (EU GMP)
• ECOVADIS
• World Health Organization (GMP / HACCP)
• TGA (Australia GMP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)
• INVIMA
• DIGEMID
• MHRA (UK GMP)

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Activity

• Oral liquids and semisolids, Oral solids / OSD, Injectables, Bottles, Oral suspensions, Syrups, Tablets, Hard capsules, Powders, Fill&Finish, Small volume vials, Large volume vials / Bottles, 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)
• DEA: Schedule V (lowest potential for abuse)
• BSL: 1
• Therapeutic areas: (J) Antiinfectives for systemic use
• Markets: DIGEMID (Peru), INVIMA (Colombia), EMA (EU), MHRA (UK), TGA (Australia), ANVISA (Brazil), Russian Health Authorities

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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, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Formulation mixing, 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, 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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