Category Archives: CMO

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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3 Key Ingredients to Custom Vitamin Formulation Development

3 Key Ingredients to Custom Vitamin Formulation Development

The development of Custom Vitamin Formulations has become more and more popular in recent years. This trend is powered by a growing population with a desire to live longer coupled with a healthier lifestyle. The U.S. vitamin and supplement market is estimated to become a $28 billion dollar a year juggernaut by the year 2016. In spite the fact that… Continue Reading

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Outsourcing Generic Formulation Development Can Improve Your Bottom Line

Outsourcing Generic Formulation Development Can Improve Your Bottom Line

Demand for outsourcing pharmaceutical formulation development and manufacturing is on the rise for drug developers at all levels. The significant number of new innovator drug patents coupled with exclusivity protections expiring or expired has resulted in many products and product categories with limited or no generic competition. This unique combination of events has created significant… Continue Reading

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3 Technologies Impacting Pharmaceutical CDMO’s

3 Technologies Impacting Pharmaceutical CDMO’s

In todays competitive environment, Pharmaceutical Contract Development Manufacturer Organizations (CDMO’s) are integrating technologies into their business processes to track, control and streamline their manufacturing process. From internal communications and project management to real time data dashboards and Enterprise Resource Planning (ERP); speed, preciseness and efficiency are vital in this day and age of manufacturing on… Continue Reading

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Gain a Competitive Advantage in the Vitamins & Dietary Supplements Market

Gain a Competitive Advantage in the Vitamins & Dietary Supplements Market

The aging baby boomer population and their increasing focus on health will continue to generate significant growth for the vitamin & dietary supplements market in 2014. In order to increase market share in this $14 billion dollars a year industry, Pharmaceutical companies are partnering with top-quality Contract Development Manufacturing Organizations (CDMOs) to improve their competitive… Continue Reading

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How to Choose The Right Pharmaceutical CMO

How to Choose The Right Pharmaceutical CMO

The Pharmaceutical Contract Manufacturing Organization (CMO) industry is a $10 Billion dollar a year industry in the U.S. alone and growing. As more companies enter this expanding market space, it is imperative to look at certain factors when partnering with a CMO. These 3 factors are Expertise, Efficiency and Innovation. Expertise – Expertise encompasses knowledge of the… Continue Reading

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Filed Under: CMO