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Information @ a Glance

General 

  • Active pharmaceutical ingredients (API)  are individual substances or a mixture of substances used to produce a drug or medical product.

  •  The traditional word for the API is pharmacon which originally denoted a magical substance or drug.

  • The API may be either unknown or may require cofactors in order to achieve therapeutic goals.

Manufacturing Process

  • 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.

  • API drug substances can be manufactured by processes like chemical synthesis, fermentation and extraction or by recovery from natural resources.

  • Raw materials for intermediate and API manufacturing should be weighed or measured under appropriate conditions that do not affect their suitability for use.

Technology

  • 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.

  • 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 

  • 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.

  • 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.

  • In Europe, the United Kingdom, Germany, France and Switzerland are the major bases for API manufacturers for the innovative sector.

  • 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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