|FDA Comment Number :||EC4|
|Submitter :||Mrs. Jennifer Docherty||Date & Time:||03/25/2005 05:03:46|
|Organization :||Apotex Inc.|
|Category :||Drug Industry|
| March 16, 2005
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket No. 2004D-0524
Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing and Controls Information
The following comment is being submitted by Apotex Inc. further to the publication of the FDA?s Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing and Controls Information.
The draft guidance includes recommendations pertaining to setting of specifications for polymorphs for solid oral and suspension dosage form products (pdf lines 259 - 261). We have no concern with the guidance as it pertains to solid oral dosage forms. However, with respect to the recommendations in Decision Tree 3 and the information in lines 283 - 286 of the guidance, it is extremely difficult and impractical to find a suitable dissolution medium that could be used to differentiate polymorphic forms in suspension. Therefore, Apotex recommends that further guidance be provided specifically related to the identification and control of polymorphism in oral suspensions in cases where is it required.
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Manager, Regulatory Affairs Strategy & Intelligence