Abbreviated New Drug Application (ANDA): Contains data that is submitted to the FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower-cost alternative to the brand-name drug it references.
Active Moiety: A molecule that is responsible for the physiological or pharmacological action of the drug substance.
Active Pharmaceutical Ingredient (API)/Bulk Drugs: API is active ingredients contained in a drug that helps it work in the body for the purpose it is made for.
Authorized Generics: Prescription drugs produced by brand pharmaceutical companies and marketed under a private label.
Antiretroviral (ARV): A drug used to prevent a retrovirus such as HIV from replicating.
Biosimilars/Biologics: A medicine made from living organisms through highly complex manufacturing processes that is similar to another biologic medicine that is already licensed by the U.S. FDA.
Branded Drugs: Drugs that are patented
Contract Research and Manufacturing Services (CRAMS): CRAMS refers to the pharmaceutical market using outsourcing services from providers in the form of contract research organizations (CROs) and contract manufacturing organizations (CMOS).
Drug Master File (DMF): DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
Establishment Inspection Report (EIR): A factual report on all the activities conducted by FDA investigators during the time spent at the manufacturing establishment.
European Medicines Agency (EMA): An agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products.
Finished Dosage Forms (FDF): A combination of the API and other excipients that make up the product you buy from the pharmacist i.e. the end product consumed by customer.
Formulation: A process of combining various chemical compounds and API to form a final drug. Formulation can be in various forms like solid, semisolid, liquid, inhaler, skin patch, etc.
Formulary: A list of brand-name and generic prescription drugs that are approved to be prescribed by a particular health insurance policy, or in a specific health system or hospital.
Generic drugs: Drugs that are off patented
Intermediate: Substance formed in a chemical process that is essential to formation of the end product of the process.
Medical Representative (MR): Their job is to promote and sell their company’s products.
New Chemical Entities (NCE): A drug that contains no active moiety that has been approved by the FDA in any other application submitted.
New Drug Application (NDA): A comprehensive document that must be submitted to the US FDA in order to request approval for marketing a new drug in the United States.
New Molecular Entity (NME): A drug that contains an active moiety that has never been approved by the FDA or marketed in the US.
Novel Drug Delivery System (NDDS): NDDS refers to the approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effects.
Oncology: A study of cancer
Orphan Drugs: A Synthetic Pharmaceutical developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance.
OTC Drugs: Over the counter drugs that can be exchanged without any prescription such as Crocin, Dolo, etc.
Pharma Benefit Manager (PBM): An intermediary between Drug companies and Patients/Insurance companies which has such a business model that helps reduce a drug price to make it affordable to the population. (To understand in detail, visit my next blog post: Summary of PPFAS video on Pharma Sector)
Prescription Drugs: Drugs that can only be consumed when prescribed by the doctor.
Remedial Cost: Costs of Remediation of a particular Environmental Defect to the extent required by applicable Environmental Law.
Specialty Generics: They are classified as high-cost, high complexity and high touch generics (Biologics) that are injectables or infused and are used to treat complex or rare chronic conditions.
US Food and Drug Administration (USFDA): Regulatory body in Pharma Sector.
Written by- Astha Sundarka
Site Title 