Category Archives: OTC Generic Drugs

Beware: Inferior OTC Generics Manufactured Abroad

Beware: Inferior OTC Generics Manufactured Abroad

Many pharmaceutical companies have started to outsource the production of generic drugs to foreign countries, such as India and China. Some online pharmacies offer both generic and branded drugs from overseas sources because it costs less to produce a drug in another country.

That lower cost can come at a price, however. While the incidents of counterfeit medicines is less than 1 percent for those manufactured in the United States and Europe, the rate is as high as 30 percent in parts of Africa, Asia and Latin America. It can be as high as 70 percent in some regions of the world.

While the FDA has regulatory purview over any generic drug in the United States, whether sold online or shipped in from foreign sources, that oversight can be lacking in practice. The FDA is obliged to partner with regulatory agencies in other countries whose standards can be somewhat less strict than the United States.

Counterfeit Ingredients to Cut Costs?

Problems can arise involving counterfeit ingredients that are substituted to cut costs in foreign-made generics. In these situations, the customer is taking a drug that is not addressing the health condition, and the condition may get worse or the patient could die. In some cases, the drug can actually contain toxic ingredients, possibly resulting in more immediate harm or even death.

Made in the USA

All of this suggests that the wisest course for anyone in need of a generic drug (or any other kind for that matter) would be to seek out one that is made in the United States. These prescription medications may cost a little more because of higher labor and regulatory costs — though those would be partly offset by lower transportation costs — domestic manufacturers have more rigorous quality controls, required both by law and by the common sense motive of not wanting to harm one’s customers. Sticking to a made-in-the-USA generic will make one less likely to take a trip to the emergency room, or the morgue, because of a shoddy, counterfeit foreign made drug. That actually means that in the long run, domestic generics are cheaper.

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Quality Assurance of Overseas Manufacturer’s Is Shaky at Best

Quality Assurance of Overseas Manufacturer’s Is Shaky at Best

Reasons to Domestically Outsource OTC Generic Manufacturing The manufacture of generic drugs, like so many other products that Americans consume, is being outsourced to facilities overseas where labor and other costs are lower than inside the United States. Many of the generic medications that Americans take for what ails them are made in China or… Continue Reading

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Pharmatech Expands Liquid Dose Production Capacity

Pharmatech Expands Liquid Dose Production Capacity

PharmaTech LLC. of Davie, FL invests in the future by recently completing expansion of its liquid dose manufacturing capacity. In the midst of a record sales year, PharmaTech expanded from one (1) liquid dose line to THREE (3) fully automated liquid lines. Two (2) additional mixing tanks were also added to the production line in order… Continue Reading

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First to File ANDA and Command an OTC Generic Drugs Market

First to File ANDA and Command an OTC Generic Drugs Market

The Abbreviated New Drug Application or ANDA, established in 1984 by the Hatch-Waxman Act, allows OTC (Over-the-Counter) generic drug companies to conduct testing prior to a branded drug’s patent expiration date. This creates an opportunity for OTC generic drug manufacturers to chip away at a branded drug’s market share. A successfully submitted ANDA allows OTC… Continue Reading

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