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General
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Active
pharmaceutical ingredients (API) are individual substances or a
mixture of substances used to produce a drug or medical product.
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The
traditional word for the API is pharmacon which originally denoted a
magical substance or drug.
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The
API may be either unknown or may require cofactors in order to achieve
therapeutic goals.
Manufacturing Process
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Active
pharmaceutical ingredients are usually first obtained in the crude
state. Subsequent production operations convert the crude material to
the final API that meets the pharmacopoeial and/or similar requirements.
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API
drug substances can be manufactured by processes like chemical
synthesis, fermentation and extraction or by recovery from natural
resources.
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Raw
materials for intermediate and API manufacturing should be weighed or
measured under appropriate conditions that do not affect their
suitability for use.
Technology
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Crystallisation is a separation and purification technique commonly used
in the chemical industry, which involves a diffusional process
accompanied by formation of a new heterogeneous phase.
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Process analytical technology (PAT) plays an important role in the
development and manufacturing of the API. It provides insight into key
factors of processes so that to understand the kinetics and mechanisms,
define critical quality attributes, and ultimately, design robust
processes to ensure the delivery of consistent and high quality of
pharmaceutical product.
Market
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Although the API industry in China is continuing to develop rapidly, it
still lags behind its Indian counterpart. Today, China continues to be
mostly a supplier of older, off-patent molecules, while Indian API
manufacturers often focus on newer, still-patented molecules.
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The pharma industry exports drugs and
pharmaceuticals worth over $ 4.5 billion. It ranks 17th in terms of
export value of bulk actives and dosage. Indian exports cover more than
200 countries including the highly regulated markets of USA, Europe,
Japan and Australia.
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In Europe, the
United Kingdom, Germany, France and Switzerland are the major bases for
API manufacturers for the innovative sector.
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Italy and Spain
are showing growth potential in the generic sector; in fact, Italy has
become one of the major bases for generic API manufacturers due to its
advantageous patent regime.
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