Region
High-income OECD
Income group
High income
Most populous city
New York City

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Disclaimer: Note that the following information is not part of the score that the country receives on the Investing Across Sectors indicators. This information is provided as complementary to the data on the foreign ownership restrictions, and is based on the survey respondents’ comments and assessments. The World Bank Group does not guarantee accuracy of this information.

Sector group:
Light manufacturing
Sector:
Pharmaceutical products: A foreign company seeking to own a manufacturing plant to produce finished medicines. Note: Excluded from the definition are (1) medicinal chemicals, (2) active pharmaceutical ingredients, and (3) research and development (R&D) activities.
Market structure:
 
Survey respondents' answer to the following question, "Define the market structure in your economy for this sector."
Competitive market, i.e. Many firms
Regulatory license:
 
Survey respondents' answer to the following question, "If a foreign company wanted to obtain a sector-specific regulatory license (or a concession contract) to open and operate a new business in that sector, how likely would the government be to issue such a license, provided that the foreign company meets all legal and regulatory requirements?"
Very likely
Name of regulatory authority
Food and Drug Administration (Department of Health and Human Services)
Additional comments:
There is generally no restriction concerning foreign ownership of a U.S. drug manufacturer. The transfer of licensing rights held by the US drug manufacturer to products approved by the Food and Drug Administration (FDA) under the Food, Drug and Cosmetic Act would likely require only the following: (1) re-registration and drug listing notifying FDA of the change in ownership and any new regulatory contacts; (2) assignment of new drug applications (NDAs)or abbreviated new drug applications (ANDAs) to the foreign purchaser by the sponsor of those applications; (3) filing of a manufacturing supplement to the NDAs or ANDAs if a new manufacturing facility, other than that contained in the approval applicationss, were to be used to produce the final products.
There are foreign firms currently operating in this sector