API or active ingredient in drugs is a biology active substance. API is also part of pesticides. Some drugs may contain more than one active ingredient or API are usually suspended in liquid medium or mixed with am excipient for delivery. Te excipient is pharmaceutically inert substance.
There is no standardization in drugs containing API especially in case of herbal mixtures. The risk factor arises for patients on multiple medications. The API can react adversely with ingredients of other medicines and this can be life threatening. Albeit there are online services to help identify API in the patients’ medicine but many are not aware.
Large amount of API is outsourced to countries like India and China especially through contract manufacture. The API and intermediate outsourcing contributes to eighty percent of total outsourced manufacture in pharmaceuticals.
Most of the contract manufacturing in India is outsourced for generic formulations. But as infrastructure in India develops further and markets grow new chemical entities will be part of outsourcing.
Fine chemicals or APIs are subject to good manufacturing practices and are hence subject to many rules and regulations. They are manufactured in separate factories where the active ingredients are mixed with excipients, solvents or inactive pigments.
More than twenty five percent API and bulk drugs were exported to EU from India. The growth in export to European countries is exponential promising a bright future for pharma companies in India.
CEP is bench mark for quality manufacture of API accorded by EQDM in Europe. According to
Phramaexcil or Pharmaceutical export Promotion Council India as many as hundred and thirty six pharmaceutical companies have received approval for CEP. When a company complies with monograph of European Pharmacopoeia it is granted this certificate.
There is great demand for API intermediates manufacture of which is mostly outsourced to India and China. With improvement in manufacturing process in these countries the prospect for industry in very bright.
Uday writes on API outsourcing to India by pharmaceutical companies in US and Europe. He also writes on contract research organizations in India. Uday writes on diverse topics related to pharma and drugs.