CDSCO Issues Guidance Document for Import & Registration of APIs
The main purpose of the document is to provide guidance for submission of application in Form 40 to the CDSCO for registration certificate and issuing license for import of drugs into India.
India's Central Drugs Standard Control Organization (CDSCO) has issued guidance document on common submission format for import and registration of active pharma ingredients (APIs) and finished formulations in India.
The main purpose of the document is to provide guidance for submission of application in Form 40 to the CDSCO for registration certificate and issuing license for import of drugs into India. The document is intended to provide non-binding guidance for use in the import and registration of bulk drugs and finished formulations in India.
The scope of the guidance is applicable to those drugs manufactured outside India, and the import registration to be issued by the CDSCO.
As per
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