1.

2 MANUFACTURING PROCESS:

Fig. No. 1.3 Basic API process layout

1.2.1 STEP BY STEP OPERATIONS IN API:

RAW MATERIAL

API SYNTHESIS

CHEMICAL /
BIOLOGICAL PROCESS

PRELIMINARY
PURIFICATION

CENTRIFUGATION

FILTRATION

CRYSTALLISATION

DRYING

TAP MILL

MICRONISATION

BLENDING

PACKING

DISPATCH

Fig. No. 1.4 Step by step process

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 Active Pharmaceutical Ingredient (API) is defined by U.S. Food & Drug
Administration as: any substance or mixture of substances intended to be used as
the active ingredient in the manufacture of a drug (medicinal) product. Such
substances are intended to furnish pharmacological activity or other direct effect
in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect
the structure or function of the body. API may exist in the form of liquids, powders,
crystals and extracts that obtained by chemical synthesis, plant extraction, or
biotechnology and is not taken by patients directly. Only when API is processed
into a pharmaceutical preparation, can the product be used for clinical use. The
synthesis of APIs is usually a complicated and multi-step process involving
numerous chemical transformations and operations on a range of raw materials
with different physical and chemical properties. Specialized expertise is needed to
achieve the synthesis of these molecules.

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