OUR EXPERTISE STARTS WITH THE MOLECULE AND EXTENDS TO THE MEDICINAL PRODUCT.
An active pharmaceutical ingredient (API) refers to any substance or mixture of substances intended to be used in the production of a medicinal product and thus becomes an active ingredient of this medicinal product. Such substances are intended to have pharmacological activity or any other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of a disease; or to affect the structure and function of the human body.
A medicinal products consists of one or more active ingredients, often present in small amounts but representing its pharmacological activity, and different non-active substances (excipients) which allow shaping (into tablets, capsules, solutions, etc.) and act on the fate of the active ingredient in the human body.
Seratec active ingredients are obtained by organic synthesis through chemical transformation steps and eventually respond to chemical entities as opposed to products from natural sources or biotechnology products. The pharmaceutical chemistry activities of Seratec APIs consist in synthesizing organic products (i.e. consisting of carbon, nitrogen, oxygen …) by the combination of raw materials (one or more starting materials and reagents), usually in a liquid medium (solvents), in a reactor or reactors, leading to the segregation of the reaction products (synthetic intermediates or active ingredients themselves depending on the progress of the reaction steps). The products are sometimes isolated in a liquid form, usually by drying in a powder form and distributed quantitatively to undergo subsequent shaping operations, under the responsibility of the pharmaceutical companies, for the manufacture of the medicinal products.
The pharmaceutical industry is the global industry that is most subject to legally binding regulations. These international regulations contribute all the recommendations essential to the organization and documentation of operations, the necessary controls in development operations, development and manufacturing of products, as well as in the quality control of manufactured products at all stages of development. The key words are to ensure the quality, safety and the efficacy of medicinal products on the market.
To do this, Good Manufacturing Practices (GMP or cGMP, current Good Manufacturing Practices) of medicinal products are the quality assurance which guarantees that medicinal products are always manufactured and controlled according to the quality standards appropriate for their intended use, as required by the marketing authorization.
A medicinal product is actually marketed by a pharmaceutical company after the issuance of a marketing authorization by the Health Authorities (MA: Marketing Authorization), which becomes the property of the laboratory (MaH: Marketing Authorization Holder) .
This MA is subject to a very strict regulatory and procedural framework which guarantees the protection of patients, resulting in the explicit authorization of the Health Authorities in the form of an ‘application.’ However, it can be transferred by awarding a license to a third party pharmaceutical company (‘MaH’), just like the shaping of the API with its excipients may be delegated by the person qualified as the MaH to a “Dosage form manufacturer”, holder of a manufacturing authorization.
The API is the substance which will act on the body. Its design, manufacture and analysis must also fulfill GMP and these activities should be documented in the form of an active substance master file (ASMF in Europe, DMF in the US). This file may take other administrative forms. This information about the chemistry, manufacturing and control of the API (CMC information), specific to a manufacturer, are added to the marketing application of the medicinal product in a common technical document (CTD). This CTD information on the API are as much a reference to the materials, facilities and equipment, staff, and their environments, as the methods and quality control system in the production, processing, packaging and storage of the API.
The confidential file of a pharmaceutically active substance, corresponding to the procedure “Active Substance Master file – ASMF” (according to European regulations CHMP / QWP / 227/02) or the procedure ‘Drug Master File – DMF’ type II (according to US regulation 21CFR314.420), is submitted by the producer of this active substance as part of an application for a marketing authorization to or a change in the marketing authorization of the MaH. The holder of the master file delivers to the MaH a “letter of access,” in reality this is an authorization given to the authorities to be able to see and review the master file in support of an application for MA.
The medicinal product containing the API(s) is not a product like others especially because the patient who takes it did not choose it and has no other control of it besides the guarantees that Western regulations impose in terms of API quality on the holder of the API Master File (ASMF Holder or DMF) and in terms of medicinal product quality, efficacy and safety that are imposed on the MaH.
On behalf of pharmaceutical companies Seratec creates and registers files of active pharmaceutical ingredients with US drug agencies: (the FDA: U.S. Food and Drug Administration) and European drug agencies (EMA: European Medicines Agency) and more recently on the Asian market.
Seratec also ensures GMP production of APIs for which we hold the master file mainly in the context of niche markets.