We arrange the synthesis of active pharmaceutical ingredients and their production
Active pharmaceutical ingredients are pharmaceutical products in the form of one or several pharmacologically active substances, regardless of the nature of their origin, intended for the production, manufacture of pharmaceutical drugs and evaluation of their efficiency (State Pharmacopeia of the XIII edition, General pharmacological articles .1.1.0006.15).
The requirements for the quality of active pharmaceutical ingredients are regulated by the Order of the Ministry of Industry and Trade of the Russian Federation of 14.06.2013 No. 916 "On Approval of the Rules for the Organization of Production and Quality Control of Pharmaceutical Products ", Part IV "Basic Requirements for Pharmaceutical Substances" used as starting material.
Introduction of active pharmaceutical ingredients in the state register of pharmaceutical products
In the production of pharmaceutical products, only active pharmaceutical ingredients included in the state register of pharmaceutical products are used (Part 4, Article 45 of the Federal Law of the Russian Federation of 12 April 2010 No. 61-Federal Act "On the circulation of pharmaceutical products").
The State Register of pharmaceutical products contains a list of pharmaceutical drugs that have passed state registration and a list of active pharmaceutical ingredients included in the composition of pharmaceutical drugs, as well as additional information about both pharmaceutical drugs and active pharmaceutical ingredients included in the register.
Active pharmaceutical ingredients of Russian origin
In accordance with Art. 54. of Federal Law of the Russian Federation of April 12, 2010 No. 61-Federal Act "On the circulation of pharmaceutical products" wholesale trade in pharmaceutical products is carried out by manufacturers of pharmaceutical products and organizations of wholesale trade in pharmaceutical products under the rules of proper distribution practice and the rules of good distribution practice.
We invite to cooperate
Innovative idea is a real opportunity to make an original product, or its improved version. Here are just a few questions that need to be answered affirmatively to realize the idea: the novelty of the project, the demand for the product, technological reproducibility, the source of financing, competence. We generate ideas, conduct their expert evaluation together with our partners and implement them.
We invite to cooperate
Pharmaceutical drugs are pharmaceutical products in the form of medicinal forms used for the prevention, diagnosis, treatment of the disease, rehabilitation, for the preservation, prevention or termination of pregnancy (Article 4 of the Federal Law of the Russian Federation of 12 April 2010 No. 61-Federal Act "On the circulation of pharmaceutical products ")