Laboratori Alchemia SRL

Laboratori Alchemia SRL

Our facilities are designed to satisfy production requirements ranging from laboratory scale for synthetically complex products or those which are even unknown in literature, to production levels of several hundred kilograms per year.

About the plant

Laboratori Alchemia has been involved in the production of high-quality APIs for the pharmaceutical industry. Through the implementation of proprietary manufacturing methods and its technologies, Alchemia can offer a vast selection of bulk APIs manufactured in compliance with the latest GMP standards. Our facilities are designed to satisfy production requirements ranging from laboratory scale for synthetically complex products or those which are even unknown in literature, to production levels of several hundred kilograms per year.

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Certifications

• EMA (EU GMP)
• World Health Organization (GMP / HACCP)
• NMPA (China GMP)
• ANVISA (Brazil B-GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• COFEPRIS
• MHRA (UK GMP)

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Activity

• CHEMICAL-SYNTHETIC, RSM (Raw Starting Materials), Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Building Blocks manufacturing

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Features

• Uses:
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
• DEA: N/A
• BSL:
• Therapeutic areas: N/A
• Markets: COFEPRIS (Mexico), EMA (EU), PMDA (Japan), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), MFDS (South Korea)

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Batch Size / Reactor

• Small, Medium

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, R&D, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, 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, Parametric release, Primary packaging, Secondary packaging, Labeling, CMC regulatory support, Crystallization screening, Fill and finish, Safety studies, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis

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