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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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European generic drug manufacturer/ API Supplier/ 6 manufacturing sites/ 5 R&D Centers/ 700 products & 250 under develop...

DMF Number

31141

Status

Active

Submission Date

2016-11-09

GDUFA DMF Review

Complete

GDUFA Review Date

2017-04-07

GDUFA Payment Date

2016-12-20

Type

II

Supporting Information

View All

Polpharma-Company-Banner

CPhI Middle East & Africa

Offering Full Spectrum of services from early stage of synthesizing potential NCE's to Large-Scale Commercial Operation.

DMF Number

32058

Status

Active

Submission Date

2017-11-13

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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Scino-Pharm-Company-Banner

CPhI Worldwide

Booth No. 40C20

Request a Meeting Now

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DMF Number

32177

Status

Active

Submission Date

2017-10-31

GDUFA DMF Review

Complete

GDUFA Review Date

2018-01-25

GDUFA Payment Date

2017-10-23

Type

II

Supporting Information

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DMF Number

33655

Status

Active

Submission Date

2019-03-29

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

32114

Status

Active

Submission Date

2017-10-03

GDUFA DMF Review

Complete

GDUFA Review Date

2017-11-01

GDUFA Payment Date

2017-10-05

Type

II

Supporting Information

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DMF Number

32126

Status

Active

Submission Date

2017-10-06

GDUFA DMF Review

Complete

GDUFA Review Date

2017-11-01

GDUFA Payment Date

2017-10-05

Type

II

Supporting Information

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DMF Number

32223

Status

Active

Submission Date

2017-11-30

GDUFA DMF Review

Complete

GDUFA Review Date

2018-01-10

GDUFA Payment Date

2017-12-07

Type

II

Supporting Information

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DMF Number

32003

Status

Active

Submission Date

2017-09-28

GDUFA DMF Review

Complete

GDUFA Review Date

2017-10-20

GDUFA Payment Date

2017-08-23

Type

II

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DMF Number

30732

Status

Active

Submission Date

2016-09-30

GDUFA DMF Review

Complete

GDUFA Review Date

2017-01-05

GDUFA Payment Date

2016-11-15

Type

II

Supporting Information

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DMF Number

31356

Status

Active

Submission Date

2017-06-02

GDUFA DMF Review

Complete

GDUFA Review Date

2017-10-02

GDUFA Payment Date

2017-08-29

Type

II

Supporting Information

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DMF Number

31490

Status

Active

Submission Date

2017-03-31

GDUFA DMF Review

Complete

GDUFA Review Date

2017-05-25

GDUFA Payment Date

2017-04-03

Type

II

Supporting Information

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DMF Number

32236

Status

Active

Submission Date

2017-12-07

GDUFA DMF Review

Complete

GDUFA Review Date

2018-01-10

GDUFA Payment Date

2017-11-30

Type

II

Supporting Information

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DMF Number

32179

Status

Active

Submission Date

2017-10-23

GDUFA DMF Review

Complete

GDUFA Review Date

2017-11-21

GDUFA Payment Date

2017-10-19

Type

II

Supporting Information

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DMF Number

31809

Status

Active

Submission Date

2017-09-27

GDUFA DMF Review

Complete

GDUFA Review Date

2017-11-16

GDUFA Payment Date

2017-09-11

Type

II

Supporting Information

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DMF Number

30248

Status

Active

Submission Date

2016-04-06

GDUFA DMF Review

Complete

GDUFA Review Date

2016-04-24

GDUFA Payment Date

2016-04-04

Type

II

Supporting Information

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DMF Number

31266

Status

Active

Submission Date

2017-03-22

GDUFA DMF Review

Complete

GDUFA Review Date

2017-06-09

GDUFA Payment Date

2017-05-25

Type

II

Supporting Information

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DMF Number

32149

Status

Active

Submission Date

2017-10-18

GDUFA DMF Review

Complete

GDUFA Review Date

2017-12-12

GDUFA Payment Date

2017-10-25

Type

II

Supporting Information

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DMF Number

30332

Status

Active

Submission Date

2016-03-29

GDUFA DMF Review

Complete

GDUFA Review Date

2017-02-03

GDUFA Payment Date

2016-09-29

Type

II

Supporting Information

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DMF Number

30866

Status

Active

Submission Date

2016-08-31

GDUFA DMF Review

Complete

GDUFA Review Date

2017-11-17

GDUFA Payment Date

2017-10-10

Type

II

Supporting Information

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DMF Number

31159

Status

Active

Submission Date

2016-12-23

GDUFA DMF Review

Complete

GDUFA Review Date

2018-03-20

GDUFA Payment Date

2017-10-10

Type

II

Supporting Information

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DMF Number

31360

Status

Active

Submission Date

2017-02-28

GDUFA DMF Review

Complete

GDUFA Review Date

2018-03-07

GDUFA Payment Date

2017-10-10

Type

II

Supporting Information

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DMF Number

32150

Status

Active

Submission Date

2017-11-08

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

32953

Status

Active

Submission Date

2018-11-06

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

32119

Status

Active

Submission Date

2017-10-10

GDUFA DMF Review

Complete

GDUFA Review Date

2018-02-02

GDUFA Payment Date

2017-11-06

Type

II

Supporting Information

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DMF Number

31180

Status

Active

Submission Date

2016-12-29

GDUFA DMF Review

Complete

GDUFA Review Date

2017-02-01

GDUFA Payment Date

2016-12-27

Type

II

Supporting Information

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DMF Number

32473

Status

Active

Submission Date

2018-07-16

GDUFA DMF Review

Complete

GDUFA Review Date

2018-07-25

GDUFA Payment Date

2018-02-09

Type

II

Supporting Information

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DMF Number

32373

Status

Active

Submission Date

2017-12-22

GDUFA DMF Review

Complete

GDUFA Review Date

2018-02-28

GDUFA Payment Date

2017-12-22

Type

II

Supporting Information

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DMF Number

31882

Status

Active

Submission Date

2017-07-12

GDUFA DMF Review

Complete

GDUFA Review Date

2017-09-14

GDUFA Payment Date

2017-08-08

Type

II

Supporting Information

ENANTIOTECH CORP LTD

Request an Update of Your Company Information, Events & Sales Content

DMF Number

31844

Status

Active

Submission Date

2017-06-15

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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