1. Learn the fundamentals of meds
Drawing distinctions between APIs and drugs makes it possible for manufacturers to
specialize, regulators to focus resources and pharmacists to align generic equivalents with
brand name products. Understanding what makes an API an API, and why having that
understanding matters, underlies the very practice and regulation of pharmacy.
APIs According to the FDA and the WHO
Specifically speaking, APIs are chemicals used in everyday prescription and over-the counter
medications. However, biologically engineered proteins and recombinant molecules created
for biotech drugs fall under different definitions and regulatory schemes.
The U.S. Food and Drug Administration defines an APIs as any substance or mixture of
substances intended to be used in the manufacture of a drug product and that, when used in
the production of a drug, becomes an active ingredient in the drug product. Such substances
are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure,
mitigation, treatment or prevention of disease or to affect the structure and function of the
body.
The World Heath Organization has developed a nearly identical API definition. Nevertheless,
The WHO’s definition was under review as of September 2012. Many international authorities
believe that a mixture of APIs actually constitutes a finished pharmaceutical product, which
would be a medication of the type the FDA refers to as a “drug product.”
Drug products that is to say, the medications pharmacists dispense and patients use include
one or more API, excipients and other ingredients ranging from dyes to alcohol and water.
Who Makes APIs?
APIs are often referred to as “bulk pharmaceuticals,” and the chemicals usually get made in
plants far removed from the facilities where tablets, oral suspensions and topical applications
are made. Produced in bulk, almost all APIs are powders.
Chemical plants in every country make bulk pharmaceuticals, but the leading suppliers of
APIs are in China and India due to mostly economies of scale.
Regardless of where an API gets made, it must meet the safety and quality standards set by
the leading drug regulator in the country where it will be used. That is, Chinese and Indian
bulk drug manufacturers that export chemicals to the United States must be inspected and
licensed by the FDA. Likewise, bulk pharmaceuticals produced for many countries in Europe
are subject to standards established by the European Medicines Agency.
Regularly inspecting and, when necessary, sanctioning chemical makers outside the country
can prove difficult. Counterfeiting, adulteration and contamination remain constant concerns
with APIs imported into the United States and elsewhere. Since 2008, the FDA had been
expanding its overseas staff charged with overseeing bulk pharmaceutical manufacturers
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2. The Generic Name Is the API
The last thing to know about APIs is also the first thing, but with a little twist.
Bulk pharmaceuticals themselves are not generic drugs, but for example, the API in Pfizer’s
Lipitor and each of its generic equivalents is atorvastatin. As noted above, making
atorvastatin into a drug product requires adding other ingredients such as excipients in order
to form tablets. Nevertheless, it is absolutely mandatory that pharmacists and pharmacy
technicians know the identity of each drug’s API because the name of the API is the generic
name of the medication.
Two conventions – United States Adopted Names and International Nonpropriety Names --
help ensure each API has a unique identity.