API’s Registration Process supported by Apteka-95 Pharmaceutical Firm, Ltd. API’s Registration Process supported by Apteka-95 Pharmaceutical Firm, Ltd.

Apteka-95 Pharmaceutical Firm, ltd. is one of the leading firms in Eastern Europe engaged in complex service of pharmaceutical and medical enterprises. It successfully cooperates with the majority of Ukrainian pharmaceutical plants supplying them different APIs and raw-materials as well as processing and analytical equipment. One of our main business activities is Registration of APIs in Ukraine. Apteka-95 Pharmaceutical Firm, ltd. is one of the leading firms in Eastern Europe engaged in complex service of pharmaceutical and medical enterprises. It successfully cooperates with the majority of Ukrainian pharmaceutical plants supplying them different APIs and raw-materials as well as processing and analytical equipment. One of our main business activities is Registration of APIs in Ukraine.

Registration of APIs in Ukraine

Substances registration procedure Substances registration (certification) procedure consists of the following steps: Step 1. We sign the Confidential Agreement and You transfer all required documents to our office. Registration documents - a package of documents, which includes manufacturer's monograph (pharmacopeia article) or materials on substance quality control methods, project of the technological regulations or the manufacturing technology; ready-made product validation methods; Quality Certificates and stability data for 3 manufacturing series. Step 2. We evaluate given materials, create the list of required documents. Step 3. We announce approximate pricing and come to an agreement with the Treaty including discounts and payment terms.

Step 4. After receiving of the prepayment we initiate the process of preparation of the documents to submission to the state bodies. This step includes translation of the dossier, conforming the documents to the requirements of the Ukrainian legislation, preparation of the missing documentation, including Analytical Normative Documentation (AND) and the Technological Normative Documentation (TND). Step 5. We submit the application in the established form and complete dossier in 3 copies to the State Pharmacological Center (SPC) of the Ministry of Health (MoH) of Ukraine. Step 6. You make necessary payments on SPC and also the second advance payment for our services. Step 7. Every copy of the dossier is transmitted to SPC specialized comissions for passing the expertise.

Step 8. You send us substance samples (together with standards if they are used in a quality monitoring) in a quantity necessary for making 3 approbations of the quality control methods. (Approbation of the quality control methods – it is a necessary procedure of the control, which is carried out on samples for achievement of conformity with the AND methods and quality certificates. For example - Appearance, Microbiological Purity, etc.) Step 9. We transfer AND project, substance samples and standards to the laboratory for passing the approbation of quality control methods, described in AND. The approbation of the quality control methods is performed in one of the analytical laboratories acredited by MoH. Step 9. We transfer AND project, substance samples and standards to the laboratory for passing the approbation of quality control methods, described in AND. The approbation of the quality control methods is performed in one of the analytical laboratories acredited by MoH. Step 10. Using obtained results of the substance expertises SPC makes motivated conclusions concerning substance effectiveness, safety and quality; recommends to approval instructions on medical application and leaf-loose, AND, models of the primary and secondary packages. Substance itself is recommended to the state registration during the session of the SPC advisory council.

Step 12. After signing the Order in the MoH about the MP registration we receive project of the Registration Certificate and discuss it with You for content coordination (1-2 weeks); then we receive Registration Certificate original in SPC (2-4 weeks). We make all efforts to speed up the process of getting the Certificate. Step 13. We send You the Act for Committed Works and copy of the Registration Certificate, after which You make final payments for the services given. Step 14. After receiving 100% payment we send You the Registration Certificate originals.

Documents required for APIs registration 1. Application form. 2. Drug Master File (DMF). 4. Stability data for 3 manufacturing series. 3. Scheme and description of the manufacturing process. 5. Stability control methods or validation data. 6. Quality Certificates for 3 manufacturing series. 7. APIs samples (quantity provided by Apteka-95 during registration process). 8. Attorney for the registration. 1. Application form. 2. Drug Master File (DMF). 4. Stability data for 3 manufacturing series. 3. Scheme and description of the manufacturing process. 5. Stability control methods or validation data. 6. Quality Certificates for 3 manufacturing series. 7. APIs samples (quantity provided by Apteka-95 during registration process). 8. Attorney for the registration.

Our Customer returns to us for the next regulatory procedure, if it is a business extension or renewal of registration, and that is our main measure of quality and competitiveness. Group of Companies Apteka-95,Ltd. Frankovskaya Street, 17., Kharkov, 61001, Ukraine Tel./Fax: +38 (057) , , Group of Companies Apteka-95,Ltd. Frankovskaya Street, 17., Kharkov, 61001, Ukraine Tel./Fax: +38 (057) , ,