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Pharma sector is in demand and hence here is a list of few terminologies & their meanings in very simple words
1. API Active Pharmaceutical Ingredient
~ Combination of key chemicals that make the drug work.
~ It's the Dosage in a drug or key chemicals that make the drug work.
1. API Active Pharmaceutical Ingredient
~ Combination of key chemicals that make the drug work.
~ It's the Dosage in a drug or key chemicals that make the drug work.
~ Intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease
2. FDF Finished Dosage Forms or Formulations
~ Actual final drug product that is meant for end consumption
2. FDF Finished Dosage Forms or Formulations
~ Actual final drug product that is meant for end consumption
~ Can be tablets, capsules, liquid solution or any other type
~ Combination of Different chemicals in addition with the key API
~ Ratios of various ingredients is highly important
~ Combination of Different chemicals in addition with the key API
~ Ratios of various ingredients is highly important
3. CMO / CDMO Contract Manufacturing Organization or Contract Development & Manufacturing Org
~ Another word for CRAMS, that is Contract Research And Manufacturing Services
~ Works for pharma companies based on it's own capabilities & capacities
~ Also known as Custom Synthesis
~ Another word for CRAMS, that is Contract Research And Manufacturing Services
~ Works for pharma companies based on it's own capabilities & capacities
~ Also known as Custom Synthesis
4. ANDA Abbreviated New Drug Application
~ Application with all the necessary data
~ Filed for review and approval of the drug
5. DMF Drug Master File
~ Submission that may be used to provide confidential detailed information
~ Application with all the necessary data
~ Filed for review and approval of the drug
5. DMF Drug Master File
~ Submission that may be used to provide confidential detailed information
~ This is about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs
~ Different type of DMFs for different requirements
Can be a useful information for many as everybody tracking pharma to good extent.
~ Different type of DMFs for different requirements
Can be a useful information for many as everybody tracking pharma to good extent.
