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Saturday, March 13, 2010

Pharma - API

Active ingredient

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An active ingredient (AI), is the substance in a pharmaceutical drug or a pesticide that is biologically active. Terms in similar use include: active pharmaceutical ingredient (API) and bulk active in medicine, or in pesticide formulations active substance may be used. Some medications and pesticide products may contain more than one active ingredient. The traditional word for the API is pharmacon or pharmakon (from Greek: (φάρμακον), adapted from pharmacos) which originally denoted a magical substance or drug.

A dosage form of a drug is traditionally composed of two things: The API, which is the drug itself; and an excipient, which is the substance of the tablet, or the liquid the API is suspended in, or other material that is pharmaceutically inert. Drugs are chosen primarily for their active ingredients.



Sterile API Guide
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API Manufacturing

In addition to Wockhardt's development and finished dosage form capabilities, we boast a state-of-the-art cGMP compliant API manufacturing facility approved by the USFDA and UKMHRA.

Key Manufacturing Capabilities & Attributes:

  • State-of-the-art facility to manufacture sterile cephalosporins API's
  • Flexibility to manufacture high value - low volume products and high volume products
  • Multipurpose plant which can manufacture several products at a time handling high pressure, high temperature (up to 250 degrees Celsius) and low temperature (up to -70 degrees Celsius) reactions
  • Macrolide production
  • DMF's filed during last three years is 30+
  • API's developed in last three years is 50+

Key Research Capabilities & Attributes:

  • R&D team consisting 70+ scientists of which 20+ scientists are PhD's
  • API R&D team is supported by a dedicated analytical group comprising 40 scientists, of which 5 are Ph.Ds.
  • 30 years of API process research experience
  • Excellent History of precise and timely implementation of projects
  • Development of solutions to generate robust API processes.
  • Equilibrium between low cost and high value added work
  • API's developed to date is 150+


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