Lenore Longley
CHE 344 - 02
Dr. Fisher
Seminar Synopsis 3
The Pharmaceutical Industry
Nathan Gonzalez of Actavis Pharmaceuticals explained the care and accuracy that must
be painstakingly given to the production of drugs. Patents are obtained by various drug
companies in order for their drugs to be sold solely by them. The patent on brand drugs expires
after 20 years and generic pharmaceuticals are allowed to manufacture a bioequivalent drug
Generic drugs have the same active ingredient, strength and dosage form as the brand drug.
Congressional acts have been passed demanding pharmaceutical companies to produce drugs
that are safe for consumption. The FDA conducts thorough inspections of these companies and
the drugs to ensure that the laws are being adhered to.
Brand and generic pharmaceuticals have different facilities within the companies. They
are a Research and Development facility, manufactory plant and quality control. A very
drugs being able to reach the market. Generic drugs are relatively inexpensive because they do
not have to go through the expensive process that brand drugs face. There is competition to get
the drugs on the market. The first generic pharmaceutical to obtain federal approval usually
dominates 40% - 60% of the market.
Drugs are made for mass production in the manufactory plant. Once produced, samples
are taken to quality control for testing. It takes approximately 14 hours to achieve 100% testing.
Six pills are used for testing and specification; the number of pills is increased after each level of
testing. Some tests include related compounds, assays, and drug release rate by HPLC for
impurities and potency, TLC, and a physical test to determine particle size, bulk and tap density
After specification, the drug is sent to the market and the drug stability is monitored till the
expiration date. If the drugs fail the specification phase, an investigation is conducted. The
pharmaceutical companies lose a lot of money once the drug is recalled