Korea’s generic drug manufacturers are entering the U.S. pharmaceutical market, one after another.

Following Daewoong Pharmaceutical and Huons, Celltrion Pharm had its factory in Ochang, North Chungcheong Province, inspected by the U.S. Food and Drug Administration, the last step for an FDA approval for generics. The FDA is expected to make the final decision as early as in six months.

Celltrion's factory in Ochang

When entering the U.S. market, new drugs are required to prove their efficacy and safety first, while generics put more focus on product quality. In other words, the first condition is to have a factory that meets the U.S. regulations.

In an inspection on a foreign drug company, the FDA checks whether the foreign company’s overall facilities and drug production lines comply with the Current Good Manufacturing Practices (cGMP), which is the U.S. criteria for drug manufacturing and management.

Celltrion Pharm has declined to reveal the name and the ingredient of the generic drug which is to be put out on the U.S. market. Sources in the pharmaceutical industry said the company is likely to unveil a new product in the U.S. market that has not launched in Korea.

Earlier, generics made by Daewoong and Huons successfully passed the FDA inspections.

Daewoong was the first Korean firm to launch a generic drug in the U.S. After receiving an FDA approval for generic antibiotic Meronepem in December 2015, the company launched the product in the U.S. the following year. Referencing AstraZeneca’s Merrem under the carbapenem segment, Meropenem treats various diseases ranging from severe bacterial infection to general infection. The company hoped that Meropenem could relieve a frequent shortage of the original drug in the U.S. market.

Huons received approval from the FDA for its 0.9 percent sodium chloride injection 5mL/10mL. The biotech firm was the first local company to get an FDA approval for a complete injection product. It also received FDA approval for abbreviated new drug application (ANDA) for the sodium chloride injection. The company seeks to register its lidocaine injection, too, to the U.S. FDA.

sjh@docdocdoc.co.kr

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