A bulk drug — also called active pharmaceutical ingredient (API) — is the chemical molecule[...]
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API
A substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a therapeutically active compound (ingredient) [Product Details...]
Intermediates
The Active Pharmaceutical Ingredient Industry is the organ by which active pharmaceutical ingredients are manufactured from raw materials through both chemical and physical means. Depending on the complexity of the molecule required, synthesis of APIs might need multi-step complex chemistry utilizing a range of processing technologies.
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Impurities
Any component of the medicinal product which is not the chemical entity defined as the active substance or an excipient of the product
Various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredient’s (API’s).
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Dosage Formulation
A Finished Dosage Form is a finished drug product resulting from Finished Dosage Formulation (FDF), the various processes involved in production such as manufacturing, testing, and subsequent approval for consumption and delivery to the public.
Active Pharmaceutical Ingredients (API’s), responsible for the results the user gets after taking the dosage forms, are involved in the FDF along with inactive ingredients (excipients) which serve as a medium for the active ingredients to function.
FDF is a critical stage in the product lifecycle and can only be achieved if the manufacturing facility of a pharmaceutical company or Contract Manufacturing Organization is up to a high-end standard. This is a major reason why some companies are into out-licensing since they don’t have the standard manufacturing facility to produce the dosage forms.
Processes Involved in Finished Dosage Formulation Development
The processes involved here are quite complex. Analysis comes first involving the active pharmaceutical ingredients and excipients. A compatibility study is also done between them.
Next is the formulation development which includes the definition of quantitative and qualitative formulas, formulating the manufacturing method, and establishment of in-process controls.
The next process is the main manufacturing process, which then proceeds to quality control, clinical trials, stability studies and manufacturing regulations before the drug product is transferred to the client if it’s been conducted by a pharmaceutical contract manufacturing organization.
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