Drugs
The United States regulates products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body of man or other animals. Registrar Corp provides Registration, U.S. Agent, Authorizing Official and compliance assistance for U.S. and Non-U.S. companies in the Drug industry.
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Over the Counter Drugs (OTC)
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A human drug that is safe and effective for use without prescription by a licensed medical practitioner.
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Prescription Drugs
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A human drug that is not safe for use except under the supervision of licensed medical practitioner.
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Active Pharmaceutical Ingredients (API)
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Any substance or mixture of substances (starting materials) intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug becomes an active ingredient of the drug product.
API Examples
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Drug Master File (DMF)
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A DMF is a submission to FDA that may be used in support of premarket submissions to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
DMF Examples
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Applicable U.S. Regulations:
FDA Regulation: 21 C.F.R. Part 201 and Section 314.420
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| Registrar Corp assists businesses with FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling FDA registration requirements. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the US Food and Drug Administration.
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