Generic drugs/products drug product

Generic drug product equivalence current status, Am. J. Manag. Care, 4, 1183 (1998). 

Correctly labeled product in the wrong carton or package. Strength of product incorrectly labeled Microbial contamination of nonsterile products. Drug product marketed without an approved new or generic... 

The study did not provide data on whether, or how, the suggested recommendations might affect brand-name companies and generic apphcant s incentives to enter the market with new brand-name or generic drug products. 

The brand-name company sued the second generic applicant for drug product G, and this litigation settled. 

See Appendix E, Question 4 for generic companies. These drug products encompass the eight products listed in Table 4-3 as subject to multiple 30-month stays. 

Generic Drug Product Development Solid Oral Dosage Forms, edited by Leon Shargel and Izzy Kanfer... 

Ahmed, S. U., Naini, V, and Wadgaonkar, D. (2005), Scale-up, process validation and technology transfer, in Shargel, L., and Kanfer, I., Eds., Generic Drug Product Development Solid Oral Dosage Form, Marcel Dekker, New York, pp. 95-136. 

In many cases, clinical production or trial runs of a new drug are produced in facilities other than the ones used for full-scale production. The facilities and controls used for the manufacture of the batch or batches are audited. For a generic drug product, the biobatch or biobatches are required to be manufactured in production facilities, using production equipment, by production personnel, and the facility is to be in conformance with cGMPs. Accurate documentation is essential so that the production process... 

Act as a constant source for development of value-added generic drug products. 

It is important to note that generic drug products can be developed and approved more quickly than innovator drugs, because clinical trials are not typically required. A 505(b)(1) or 505(b)(2) NDA holder may delay approval of an ANDA due to patent or exclusivity considerations, however. These issues, however, while described briefly later, are beyond the scope of this chapter. 

Generic and trade name of drug or drug product... 

The name and address of the sponsor the name of the sponsor s primary contact person and/or resident agent including title, address, and telephone number the generic and trade name, if any, of the drug or drug product and the name and address of the source of the drug if it is not manufactured by the sponsor. 

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