{"id":17,"date":"2026-06-18T10:26:40","date_gmt":"2026-06-18T10:26:40","guid":{"rendered":"https:\/\/new.medalchemy.com\/?page_id=17"},"modified":"2026-06-26T12:41:22","modified_gmt":"2026-06-26T12:41:22","slug":"home","status":"publish","type":"page","link":"https:\/\/medalchemy.com\/","title":{"rendered":"Home"},"content":{"rendered":"\t\t
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Delivering High-Value
Pharmaceutical Innovation<\/h1>\n\t\t
\n \t\t\t20+ Years of research<\/span>\n\t\t\t\t\tAPI Development Experts<\/span>\n\t\t\t\t\tGMP Certified<\/span>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n
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Technology-driven pharmaceutical R&D company founded in 2002. We develop high-value therapeutics, APIs, and new chemical entities within GMP-certified environments for clinical and pharmaceutical use. We also provide trusted CRO services for third-party research and development.<\/em><\/h2>\n\t\t\n<\/div>\n
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Our services<\/h4>\n\t\t\n<\/div>\n\t\t
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Initial research and custom synthesis<\/h4>\n\t\t\t\t\t

We can synthesise building blocks, intermediates, APIs or any other molecule you are seeking from milligrams to several grams.<\/p>\n\t\t\n<\/div>\n

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Process development<\/h4>\n\t\t\t\t\t

Synthetic routes can be based on existing literature or we can provide alternative new pathways.<\/p>\n\t\t\n<\/div>\n\n<\/div>\n

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Scale-up<\/h2>\n\t\t\t\t\t

From the lab bench we can choose the most economically and ecologically viable synthetic process and prepare from grams to some kilos in our kilolab.<\/p>\n\t\t\n<\/div>\n

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Pilot plant<\/h2>\n\t\t\t\t\t

In our pilot plant we can manufacture up to 25-30 kg per batch following the ICH Q7 guidelines if required. We can validate the manufacturing process so you can use the product in clinical trials or as an API. <\/p>\n\t\t\n<\/div>\n\n<\/div>\n

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Validation of analytical methods<\/h2>\n\t\t\t\t\t

We can synthesise building blocks, intermediates, APIs or any other molecule you are seeking from milligrams to several grams.<\/p>\n\t\t\n<\/div>\n

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Stability studies<\/h2>\n\t\t\t\t\t

We can perform stability studies following ICH-Q1A (R2) and ICH-Q1B guidelines. We offer both sample storage in climatic chambers and analysis of such samples.<\/p>\n\t\t\n<\/div>\n

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Physical and chemical and microbiological testing<\/h2>\n\t\t\t\t\t

We can do physicochemical and microbiological testing upon request.<\/p>\n\t\t\n<\/div>\n\n<\/div>\n

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Good manufacturing practice<\/h2>\n\t\t\t\t\t

If your target molecule has any regulatory need, we can perform the manufacturing process under cGMP at any scale. <\/p>\n\t\t\n<\/div>\n

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Drug master files<\/h2>\n\t\t\t\t\t

We can write ASMF for existing active substances or new ones for marketing authorisation.<\/p>\n\t\t\n<\/div>\n

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Investigational medicinal product dossier<\/h2>\n\t\t\t\t\t

In addition, IMPDs can be drafted for your molecules to be used in clinical trials. <\/p>\n\t\t\n<\/div>\n\n<\/div>\n

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Our products<\/h4>\n\t\t\t\t
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Fine
chemicals<\/h3>\n\t\t\t\t\t

High-purity chemical compounds developed for pharmaceutical and research applications.<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

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Impurities of
pharmaceuticals<\/h3>\n\t\t\t\t\t

Reference impurities and analytical materials produced for pharmaceutical testing and validation.<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

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Chemical
intermediates<\/h3>\n\t\t\t\t\t

Specialized chemical intermediates designed to support complex synthesis and manufacturing processes.<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

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New
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Research and development of innovative molecules with therapeutic potential and commercial value.<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

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Small
volume APIs<\/h3>\n\t\t\t\t\t

GMP-compliant active pharmaceutical ingredients produced in small-scale batches for clinical and specialized use.<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

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Small
volume drugs<\/h3>\n\t\t\t\t\t

GMP-compliant active pharmaceutical ingredients produced in small-scale batches for clinical and specialized use.<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t

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Our Equipment
& Facilities<\/h4>\n\t\t\n<\/div>\n
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Medalchemy offers a wide range of laboratory and pilot plant facilities for chemical and pharmaceutical projects. We also have access to specialist equipment for the distillation of kilo quantities of high-boiling, heat-sensitive materials, as well as low-temperature reactions down to -90\u00b0C. Projects can be carried out under cGMP or ISO 9000 environments upon request.<\/em><\/h2>\n\t\t\t\t\t

Available equipment<\/p>\n\t\t

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      Contact us<\/h2>\n\t\t
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