Pharmaceutical products comprise of product/s which are used to diagnose, prevent, treat or cure any disease or medical condition. These products include a wide range of prescription medicines, over-the-counter medicines, vaccines, diagnostic agents and biologics. Pharmaceutical products are taken internally and should be free from any impurities or contaminants else they will cause toxicity and harmful side effects. Thus high quality raw materials need to be used in the entire process to ensure that the final pharmaceutical product is safe.
The key component of any medicine is Active Pharmaceutical Ingredients (APIs) and can be considered as the most important raw material in the production of pharmaceuticals. APIs are responsible for the therapeutic effect of any medicine. APIs need to be pure as impurities can prove to be harmful to the patient. In addition to the purity, potency plays a very important role. Potency refers to the percentage of the API in the medicine. The potency of the API must be within the specified range to ensure that the medicine is effective in treatment of a specific disease or medical condition.
However, the most important factor which impacts the quality of the API is the manufacturing process. High quality raw materials from reputed suppliers should be used for manufacturing. The manufacturing process needs to be well controlled and monitored. It should not deviate from the expected manufacturing standards as this could lead to impurities or variations in the quality of APIs. There should be a dedicated purification process to ensure that the impurities which may be present in the raw materials or which may arise during the production process are removed. Throughout the manufacturing process the APIs need to undergo quality testing to ensure that they meet the expected quality standards. The quality testing can include testing for purity, potency and stability and should be performed by qualified persons. The manufacturing facility needs to be fully equipped to ensure high quality API production and quality testing.
India is one of the largest suppliers of APIs globally. Hence, it is imperative that the APIs which are manufactured are packaged effectively. The packaging must be undertaken in such a fashion that the final product is safe, effective and meets the required standards expected.
DU Organics manufactures various API Intermediates which are used in pharmaceutical production. For obtaining more information with respect to the same, visit our website or contact us today.