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P. 78-82 /

Analytical and formulation attributes in developing generic sterile injectable liquid and lyophilized drugs (part 1)


*Corresponding author
1. Boehringer Ingelheim Ben Venue Laboratories, 300 Northfield Rd, Bedford, OH 44146
2. Current address: Oakwood Laboratories, 7670 first place, Oakwood village, OH 44146


A generic drug manufacturer typically spends much less time preparing an Abbreviated New Drug Application (ANDA) than the New Drug Application (NDA) to establish equivalency to the innovator’s product and allow access to the market. For a given drug product, the formulation information is often listed in the package insert of the branded drug, providing valuable formulation information to generic developers. In this two part article generic sterile injectable development processes are discussed. Part 1 of this article discusses several aspects of the development processes including deformulation, API selection, container closure, filter validation and product compatibility studies.


A generic drug has the same active ingredient(s) as the reference listed drug (RLD) or branded drug. It also has the same dosage form, strength and conditions for use as the RLD. Approximately 60 percent of prescriptions in USA are now filled with generic drugs, and research shows that generics work as well as their branded counterparts. Generic manufacturers are able to sell products for lower prices, not because the products are of any lesser quality, but because the generic manufacturers generally do not engage in costly advertising and promotion or need to recoup the expense of drug design, development and multiphase clinical testing. The FDA reports very few adverse events related to specific generic drugs that are not related to known side effects of the drug ingredient itself (1).

Generic drug development
Understanding the chemistry and details of RLD is very critical to the development of good quality generic products. Using the materials listed on the RLD label without understanding the purpose of each ingredient present lead to problems later, such as investigation of out of specification results or ...

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