API Abbreviated as Active Pharmaceutical Ingredient is a new market consent in today’s Pharma World. Drugs are available as tablets or capsules but their actual compositions are not homogeneous. Drugs consist of many chemicals but only the portion which actually works in treating the condition, that is, the active parts is called API. Sometimes a drug contains many API and the reaction to any of that drug depends on the dosage prescribed, which varies from one person to another. The function of API is to treat or cure of the disease or symptoms and for diagnosis or prevention at times.
Usually, a manufacturer of the pharma products is invited to provide its APIMF (API Master File) for applying prequalification of an FPP (Finished Pharmaceutical Product).Identifying APIs that are of good quality and manufactured according to WHO Good Manufacturing Practices (GMP) is known as prequalification of API. If a prequalified API is used in the manufacture of FPPthen it is greatly facilitated.Regulatory submission requirements for API are very specific and different for every Health Authorities. Expertise and experience in filing DMFs, ASMFs, CEPs, and active ingredient master files to global health authorities help in quick approval of drug product applications.
A confidential, detailed document provided by API is called DMF (Drug Master File). Your company products will be considered reliable in terms of regulatory standards, aquality and ability to meet cGMP (Current Good Manufacturing Process) if your products have large number of DMFs. Depending on the country where your product has to be marketed, the standards of the API manufacturers will differ in bringing enormous differenceamong regulatory requirements in those countries. Tammina Life Science complies with WHO GMP foreach API or intermediate manufacturing site. Tammina Life Science professionals will submit an application for prequalification. They will further request an inspection by WHO of your manufacturing site so that compliance with WHO GMP can be assessed for your products.
Tammina Life Science professionals take care of documents and specifications required for APIMF and DMF. They will have records of equipment cleaning and maintenance. Tammina Life Science experts keep records of raw materials, intermediate, API Labelling and packaging materials. They control record of master production, batch production and laboratory control. Material management is also done by us. Production and in-process control are taken care of by Tammina Life Science. Sampling and testing are also done by Tammina Life Science Experts.
Tammina Life Science API Expertise :
- We take care of DMF (Drug Master File) Submission.
- We make DMF in line with other global health authority’s requirements for APIs.
- We take care of APIMF Submission.
- We make Investigational Medicinal Product Dossier.
- Market Consent Application
- We design specifications for starting materials of drugs, raw materials of medicines, excipients of medicines, packing materials, in-process, intermediates and drug substance.
- Tammina Life Science Regulatory professionals maintain the records of the manufacturer, the quantity of each shipment of each batch of raw material, labelling and packaging materials for API.
- We request number for Pre-assigned DMF.
- Tammina Life Science experts handle pre-submission admin activities.
- Tammina Life Science experts have great experience in submission and compilation.