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List of Drug Master Files (DMF) of Apremilast Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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AMT01 (INTERMEDIATE FOR APREMILAST)

APREMILAST

APREMILAST (AMORPHOUS)

APREMILAST (CRYSTALLINE)

APREMILAST (FORM B)

APREMILAST (FORM M)

APREMILAST (FORM-B)

APREMILAST (FORM-M)

APREMILAST [AMORPHOUS]

APREMILAST [ROUTE CODE LI]

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CHINA

INDIA

POLAND

SLOVENIA

SPAIN

TAIWAN

UNITED KINGDOM

UNITED STATES

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32177
Active
2017-10-31
Complete
2018-01-25
2017-10-23
II

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32114
Active
2017-10-03
Complete
2017-11-01
2017-10-05
II

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32126
Active
2017-10-06
Complete
2017-11-01
2017-10-05
II

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32223
Active
2017-11-30
Complete
2018-01-10
2017-12-07
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

32003
Active
2017-09-28
Complete
2017-10-20
2017-08-23
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

30732
Active
2016-09-30
Complete
2017-01-05
2016-11-15
II

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31356
Active
2017-06-02
Complete
2017-10-02
2017-08-29
II

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31490
Active
2017-03-31
Complete
2017-05-25
2017-04-03
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

32236
Active
2017-12-07
Complete
2018-01-10
2017-11-30
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

32179
Active
2017-10-23
Complete
2017-11-21
2017-10-19
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

31809
Active
2017-09-27
Complete
2017-11-16
2017-09-11
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

30248
Active
2016-04-06
Complete
2016-04-24
2016-04-04
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

31266
Active
2017-03-22
Complete
2017-06-09
2017-05-25
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

32149
Active
2017-10-18
Complete
2017-12-12
2017-10-25
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

30332
Active
2016-03-29
Complete
2017-02-03
2016-09-29
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

30866
Active
2016-08-31
Complete
2017-11-17
2017-10-10
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

31159
Active
2016-12-23
Complete
2018-03-20
2017-10-10
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

31360
Active
2017-02-28
Complete
2018-03-07
2017-10-10
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

32119
Active
2017-10-10
Complete
2018-02-02
2017-11-06
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

31180
Active
2016-12-29
Complete
2017-02-01
2016-12-27
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

32473
Active
2018-07-16
Complete
2018-07-25
2018-02-09
II

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

32373
Active
2017-12-22
Complete
2018-02-28
2017-12-22
II

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31882
Active
2017-07-12
Complete
2017-09-14
2017-08-08
II

ENANTIOTECH CORP LTD

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31844
Active
2017-06-15
N/A
II

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