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As per available reports about10 relevant journals, 71 Conferences, 6 workshops are presently dedicated exclusively to pharmaceutical ingredients and about 1543 articles are being published on pharmaceutical ingredients.
Pharmaceutical ingredients are the chemicals in drug products that make the medications work. Any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings. The dosage form for a pharmaceutical contains the active pharmaceutical ingredient (API), which is the drug itself, and excipients, which are the substances of the tablet, or the liquid the API is suspended in, or other material that is pharmaceutically inert.
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Scope and Importance
Drugs are chosen primarily for their active ingredients. Patients often have difficulty identifying the active ingredients in their medication, and are often unaware of the notion of an active ingredient. When patients are on multiple medications, active ingredients can interfere with each other, often resulting in severe or life-threatening complications. There now exist online services which can identify the active ingredient of most medications, such as the Medicines database providing information on medications available in Australia.
In phytopharmaceutical or herbal medicine, the active ingredient may be either unknown or may require cofactors in order to achieve therapeutic goals. This leads to complications in labeling. One way manufacturers have attempted to indicate strength is to engage in standardization to a marker compound. However, standardization has not been achieved yet: different companies use different markers, or different levels of the same markers, or different methods of testing for marker compounds. For instance, St John's wort is often standardized to the hype ricin which is now known not to be the "active ingredient" for antidepressant use. Other companies standardize to hyperforin or both, although there may be some 24 known possible active constituents. Many herbalists believe that the active ingredient in a plant is the plant itself. The manufacture of products based on small-molecule Active Pharmaceutical Ingredients (API) remains critical to global healthcare. The manufacturing landscape is also full of challenges and opportunities. This is due to emerging international markets and rapidly evolving social, economic, regulatory and environmental expectations.
The market was valued at US$1.56 billion in 2013 and is estimated to reach a value of US$4.49 billion by the end of 2020.With the help of regulatory affairs outsourcing, life science, pharmaceutical, and medical device manufacturing companies are able to get their drugs or devices approved or launched in the global market. Regulatory affairs outsourcing by biopharmaceutical companies has minimized losses due to recalls and product approval delays. Regulatory affairs service providers also provide effective services such as clinical trial services, medical writing, and pharmacovigilance to biotech, pharma, and medical device companies.
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This page was last updated on 14th Sep, 2015
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