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The dosage form for a pharmaceutical contains the active pharmaceutical ingredient, which is the drug substance itself, and excipients, which are the ingredients of the tablet, or the liquid in which the active agent is suspended, or other material that is pharmaceutically inert. Drugs are chosen primarily for their active ingredients.
A combination drug or a fixed-dose combination (FDC) is a medicine that includes two or more active ingredients combined in a single dosage form. [1] Terms like "combination drug" or "combination drug product" can be common shorthand for an FDC product (since most combination drug products are currently FDCs), although the latter is more precise if in fact referring to a mass-produced product ...
Fluctuations in dosage of the Active Pharmaceutical Ingredient, caused by uneven distribution of the API in the tableting blend (either due to poor mixing or separation in process). Sticking of the powder blend to the tablet tooling, due to inadequate lubrication, worn or dirty tooling, or a sticky powder formulation; Capping, lamination or ...
Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form.It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.
This means that one drug can have more than one code, for example acetylsalicylic acid (aspirin) has A01AD05 as a drug for local oral treatment, B01AC06 as a platelet inhibitor, and N02BA01 as an analgesic and antipyretic; as well as one code can represent more than one active ingredient, for example C09BB04 is the combination of perindopril ...
An International Nonproprietary Name (INN) is an official generic and nonproprietary name given to a pharmaceutical substance or an active ingredient, [1] encompassing compounds, peptides and low-molecular-weight proteins (e.g., insulin, hormones, cytokines), as well as complex biological products, such as those used for gene therapy. [2]
Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form .
The R&D group at teva api consists of a team of over 760 top scientists located in 7 development centers worldwide: A large center in Israel (synthetic products and peptides), a large center in Hungary (fermentation and semi-synthetic products), and a facility in India and additional sites in Italy, Croatia, Mexico and the Czech Republic (development of high potency API). teva api's R&D ...