Dear Zhongua Pharmaceutical Factory Representative,
We are currently looking for a raw material supplier to manufacture griseofulvin USP microcrystallized raw material for a product to be marketed for humans in the US. I noticed that Zhongua Pharmaceutical Factory has an active DMF for griseofulvin material (DMF# 15899).
I understand Zhongua Pharmaceutical Factory does not manufacture griseofulvin anymore. Who could I speak with to discuss the possibility of manufacturing once again? We would consider EP/BP if there is per chance an exclusive agreement on the USP grade material.
The details which we could further discuss are as follows:
We would initially need 366 Kg of Griseofulvin for developing our product.
Commercially our forecast is for 1,856 Kg API the first year, 2,475 Kg the second year, and 3,712 Kg the third.
Please provide a quote for 366 Kg and then for 1,856 Kg starting next year.
Since the material is being used in a product that we are planning on marketing in the US additional information that we need is any one of the 3 items listed below:
1) be provided with a DMF#, OR
2) to have the manufacturer be willing to apply for a DMF which we could help, OR
3) the company would be willing to provide information to our company under confidentiality or directly to the US FDA (eg. general properties of material, characterization, specification, analytical methods, validation of methods, container closure, analytical testing methods, stability et. al.)
Please let us know as soon as you can and thanks for your time.
John J. Oberholtzer
John J. Oberholtzer, J.D.
Director Regulatory Affairs and Quality Systems
Elorac, Inc.
100 Fairway Drive Suite 134
Vernon Hills, IL 60061
847-362-8200 xt. 231 direct
847-362-8394 fax
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