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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Apotex Fermentation Inc.

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01 Cyclosporine (1)

02 Everolimus (1)

03 Sirolimus (1)

04 Tacrolimus (1)

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01 Active (3)

02 Blank (1)

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01 Withdrawn by Holder (1)

02 Blank (3)

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01 Blank (4)

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01 Blank (4)

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USDMF

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31073
Active
BULK EVEROLIMUS
2016-10-27
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
31073
Status
Active
Fees Paid
Reviewed
 
Filing Details
BULK EVEROLIMUS
Issue/Submission Date
2016-10-27
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USDMF

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26904
Active
SIROLIMUS DRUG SUBSTANCE
2013-02-27
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
26904
Status
Active
Fees Paid
Reviewed
 
Filing Details
SIROLIMUS DRUG SUBSTANCE
Issue/Submission Date
2013-02-27
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USDMF

Found USDMF

28065
Active
TACROLIMUS USP
2014-03-17
CEP/COS

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Japanese DMF

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Application Number
28065
Status
Active
Fees Paid
Reviewed
 
Filing Details
TACROLIMUS USP
Issue/Submission Date
2014-03-17
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USDMF

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CEP/COS

Caution CEP/COS

R0-CEP 2015-367 - Rev 00
Withdrawn by Holder
Ciclosporin
2017-11-27
Japanese DMF

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Written Confirmation

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Application Number
Status
Withdrawn by Holder
 
Filing Details
Ciclosporin
Issue/Submission Date
2017-11-27
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