Important facts about API

  • Active Pharmaceutical Ingredient (API) is the Active ingredient (AI) in a pharmaceutical drug and is biologically active. Depending upon the formulation, the number of Active Ingredients is decided. They can be 1 or many. Here, the active terms denote the active substance of interest in a plant.
  • Active Pharmaceutical ingredients possess pharmacological activity and have the direct effect on the diagnosis, cure, treatment, and prevention of a disease. They directly affect the functioning of the body.
  • APIs are at first obtained in the crude state. Later, production operations are done on it that that converts the crude material into final API. In some cases, an additional step is done to make the APIs sterile. They are processed more to remove any sort of microorganisms, particles, and endotoxins from it.
  • All the drugs are made up of two central components. One is active pharmaceutical ingredients and the second is the excipient. The excipient is the substance inside the drugs that helps the medicine to reach the body system and is chemically inactive. Like for example, a medical drug for head ache has acetaminophen as the active ingredient and the liquid in the capsule is the excipient.
  • The quality of API is another significant aspect. Poor APIs can cause serious illness and even death. For outsourcing purpose, APIs have to follow the stringent rule of both the countries. Screening has to be done ensure the quality, efficacy, safety, and any defects. If any of the API manufacturers, violates the developed standards it can result into huge penalties and recalls for the manufacturer.
  • GMP requirement for the manufacture of APIs. As per GMP guidelines, the manufacturers should carry out API production under conditions that minimize the contamination risk coming from the environment. The equipment designs to be operated are to be cleaned and sterilised under aseptic processes.
  • The leading API manufacturer is TEVA Pharmaceuticals. They manufacture more than 300 API products. Aurobindo and Cipla are two another companies manufacturing around 200 APIs. Dr. Reddy lab is yet another API manufacturing company producing around 60 APIs. In India, there are around 1600 pharmaceutical API manufacturers in India.
  • The pharmaceutical companies in India that manufacture API are Glaxosmith Kline, Aurobindo Pharma, Matrix, Cipla, Divi’s lab rotaries, Teva Active Pharmaceutical Ingredients, Sun Pharma, IPCA, and Dr. Reddy Laboratories. India and China are the largest pharmaceutical API manufacturers globally. Many of them are outsourcing the APIs so as to cut the cost of high-end equipment’s, labour, and infrastructure.
  • API market is increasing drastically. By next year, China would account for 30% of global generic API merchant market. After China, its USA and India are who the leading manufacturers of generic APIs. The sale of API is increasing by 40-50% per year. The growth of APIs is increasing due to domestic sales and exports. In India and US, both the domestic sale and export is good enough to generate a handful of revenue.

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