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Common chemistry, manufacturing, and control deficiencies in abbreviated new drug applications assessed by the US Food and drug administration: Hurdle to access cost-effective medicines

Kulkarni, SB; Gaikwad, VL

Gaikwad, VL (通讯作者),Natl Inst Pharmaceut Educ & Res NIPER, Dept Pharmaceut, Hajipur 844102, Bihar, India.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS, 2023; 123 ():

Abstract

To market a generic product in the United States, it must be registered in Common Technical Document (CTD) format with the US Food and Drug Administra......

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