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    List of all Manufacturers, Suppliers & Exporters of Apremilast API listed on PharmaCompass with details of regulatory filings

    Apremilast
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    ALEMBIC PHARMACEUTICALS LTD

    ALKEM LABORATORIES LTD

    AUROBINDO PHARMA LTD

    CADILA HEALTHCARE LTD

    CHEMO

    CIPLA LTD

    Chongqing Huapont Pharmaceutical Co. Ltd

    Cipla Ltd

    DEAFARMA

    DR REDDYS LABORATORIES LTD

    ENANTIOTECH CORP LTD

    Farmak JSC

    GLENMARK LIFE SCIENCES LTD

    HETERO DRUGS LTD

    Hangzhou Longshine Bio-Tech Co., Ltd

    Haoyuan Chemexpress Co.Ltd

    INTAS PHARMACEUTICALS LTD

    LEK PHARMACEUTICALS DD

    LUPIN LTD

    Laxmidas Dahyabhai & Co

    Lewens Labs

    MACLEODS PHARMACEUTICALS LTD

    MSN LIFE SCIENCES PRIVATE LTD

    MYLAN LABORATORIES LTD

    NEULAND LABORATORIES LTD

    Olainfarm JSC

    Omgene Life Sciences Pvt. Ltd

    QUIMICA SINTETICA SA

    RAKS PHARMA PVT LTD

    SCINOPHARM TAIWAN LTD

    SUN PHARMACEUTICAL INDUSTRIES LTD

    Srini Pharmaceuticals Ltd.

    Tecoland Corporation

    Teva Pharmaceutical Industries Ltd.

    UNICHEM LABORATORIES LTD

    ZAKLADY FARMACEUTYCZNE POLPHARMA SA

    ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

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    ZAKLADY FARMACEUTYCZNE POLPHARMA SA

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

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    USDMF

    Application Number
    31141
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
    Filing Details
    APREMILAST
    Issue/Submission Date
    2016-11-09
    Supporting Info

    1. Pipeline Product; EU DMF Available

    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Pipeline Product; EU DMF Available

    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Pipeline Product; EU DMF Available

    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Pipeline Product; EU DMF Available

    Application Number
    31141
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
     
    Filing Details
    APREMILAST
    Issue/Submission Date
    2016-11-09
    Supporting Info

    1. Pipeline Product; EU DMF Available

    Polpharma-Company-Banner

    CPhI Middle East & Africa

    Attending

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    SCINOPHARM TAIWAN LTD

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

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    USDMF

    Application Number
    32058
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - N/A
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-11-13
    Supporting Info

    1. Product Presentation

    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Application Number
    32058
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - N/A
     
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-11-13
    Supporting Info

    1. Product Presentation

    Scino-Pharm-Company-Banner

    CPhI Worldwide

    Booth No. 40C20

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    Tecoland Corporation

    Trusted API partner since 2002.

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    USDMF

    Application Number
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    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    CEP/COS

    Application Number
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    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Tecoland-Company-Banner

    CPhI Worldwide

    41P56

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    ALEMBIC PHARMACEUTICALS LTD

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

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    USDMF

    Application Number
    32177
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-10-31
    Supporting Info
    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info
    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Application Number
    32177
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
     
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-10-31
    Supporting Info

    ALEMBIC PHARMACEUTICALS LTD

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    USDMF

    Application Number
    33655
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - N/A
    Filing Details
    APREMILAST (FORM-B)
    Issue/Submission Date
    2019-03-29
    Supporting Info
    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info
    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Application Number
    33655
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - N/A
     
    Filing Details
    APREMILAST (FORM-B)
    Issue/Submission Date
    2019-03-29
    Supporting Info

    ALKEM LABORATORIES LTD

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    USDMF

    Application Number
    32114
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-10-03
    Supporting Info
    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info
    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Application Number
    32114
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
     
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-10-03
    Supporting Info

    AUROBINDO PHARMA LTD

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    USDMF

    Application Number
    32126
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-10-06
    Supporting Info
    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info
    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Application Number
    32126
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
     
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-10-06
    Supporting Info

    CADILA HEALTHCARE LTD

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    USDMF

    Application Number
    32223
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-11-30
    Supporting Info
    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info
    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Application Number
    32223
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
     
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-11-30
    Supporting Info

    CHEMO

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    USDMF

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Samples Available; Tech Pack Available; Validation Batch Available; DMF Availablility- 4Q17; Manufacturer- Quimica Sintetica S.A.

    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Samples Available; Tech Pack Available; Validation Batch Available; DMF Availablility- 4Q17; Manufacturer- Quimica Sintetica S.A.

    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Samples Available; Tech Pack Available; Validation Batch Available; DMF Availablility- 4Q17; Manufacturer- Quimica Sintetica S.A.

    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Samples Available; Tech Pack Available; Validation Batch Available; DMF Availablility- 4Q17; Manufacturer- Quimica Sintetica S.A.

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Samples Available; Tech Pack Available; Validation Batch Available; DMF Availablility- 4Q17; Manufacturer- Quimica Sintetica S.A.

    Chongqing Huapont Pharmaceutical Co. Ltd

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    USDMF

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Spec-In-house; Product Status-Pilot

    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Spec-In-house; Product Status-Pilot

    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Spec-In-house; Product Status-Pilot

    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Spec-In-house; Product Status-Pilot

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Spec-In-house; Product Status-Pilot

    CIPLA LTD

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    USDMF

    Application Number
    32003
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-09-28
    Supporting Info

    1. Product Under Development - Pre-Validation; Product Available as Apremilast Form B

    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Under Development - Pre-Validation; Product Available as Apremilast Form B

    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Under Development - Pre-Validation; Product Available as Apremilast Form B

    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Under Development - Pre-Validation; Product Available as Apremilast Form B

    Application Number
    32003
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
     
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-09-28
    Supporting Info

    1. Product Under Development - Pre-Validation; Product Available as Apremilast Form B

    Cipla Ltd

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    USDMF

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Under Development - Pre-Validation; Product Available as Apremilast Form B

    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Under Development - Pre-Validation; Product Available as Apremilast Form B

    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Under Development - Pre-Validation; Product Available as Apremilast Form B

    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Under Development - Pre-Validation; Product Available as Apremilast Form B

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Under Development - Pre-Validation; Product Available as Apremilast Form B

    DEAFARMA

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

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    USDMF

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Under Development

    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Under Development

    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Under Development

    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Under Development

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Under Development

    DR REDDYS LABORATORIES LTD

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    USDMF

    Application Number
    31356
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
    Filing Details
    APREMILAST [AMORPHOUS]
    Issue/Submission Date
    2017-06-02
    Supporting Info
    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info
    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Application Number
    31356
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
     
    Filing Details
    APREMILAST [AMORPHOUS]
    Issue/Submission Date
    2017-06-02
    Supporting Info

    DR REDDYS LABORATORIES LTD

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

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    USDMF

    Application Number
    30732
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
    Filing Details
    APREMILAST (FORM B)
    Issue/Submission Date
    2016-09-30
    Supporting Info
    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info
    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Application Number
    30732
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
     
    Filing Details
    APREMILAST (FORM B)
    Issue/Submission Date
    2016-09-30
    Supporting Info

    Farmak JSC

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    USDMF

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. DMF Under Development; In Development (Laboratory)

    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. DMF Under Development; In Development (Laboratory)

    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. DMF Under Development; In Development (Laboratory)

    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. DMF Under Development; In Development (Laboratory)

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. DMF Under Development; In Development (Laboratory)

    GLENMARK LIFE SCIENCES LTD

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    USDMF

    Application Number
    31490
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-03-31
    Supporting Info
    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info
    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Application Number
    31490
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
     
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-03-31
    Supporting Info

    Hangzhou Longshine Bio-Tech Co., Ltd

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    USDMF

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Haoyuan Chemexpress Co.Ltd

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    USDMF

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. CAS No: 608141-41-9

    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. CAS No: 608141-41-9

    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. CAS No: 608141-41-9

    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. CAS No: 608141-41-9

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. CAS No: 608141-41-9

    HETERO DRUGS LTD

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    USDMF

    Application Number
    32236
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
    Filing Details
    APREMILAST (FORM-B)
    Issue/Submission Date
    2017-12-07
    Supporting Info

    1. Product Presentation

    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Product Presentation

    Application Number
    32236
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
     
    Filing Details
    APREMILAST (FORM-B)
    Issue/Submission Date
    2017-12-07
    Supporting Info

    1. Product Presentation

    INTAS PHARMACEUTICALS LTD

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    USDMF

    Application Number
    32179
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
    Filing Details
    APREMILAST (AMORPHOUS)
    Issue/Submission Date
    2017-10-23
    Supporting Info
    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info
    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Application Number
    32179
    Status
    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
     
    Filing Details
    APREMILAST (AMORPHOUS)
    Issue/Submission Date
    2017-10-23
    Supporting Info

    Laxmidas Dahyabhai & Co

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    USDMF

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Specs- USP

    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Specs- USP

    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Specs- USP

    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Specs- USP

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info

    1. Specs- USP

    LEK PHARMACEUTICALS DD

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    USDMF

    Application Number
    31809
    Status
    Status - Active
    Facility Fees - Unpaid
    DMF Review - Complete
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-09-27
    Supporting Info
    CEP/COS

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Japanese DMF

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Supporting Info
    Written Confirmation

    Application Number
    Status
    Filing Details
    Issue/Submission Date
    Supporting Info
    Application Number
    31809
    Status
    Status - Active
    Facility Fees - Unpaid
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    APREMILAST
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    2017-09-27
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    Lewens Labs

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    LUPIN LTD

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    2017-03-22
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    2017-03-22
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    MACLEODS PHARMACEUTICALS LTD

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    32149
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    APREMILAST
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    2017-10-18
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    APREMILAST
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    MSN LIFE SCIENCES PRIVATE LTD

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    2017-02-28
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    Application Number
    31360
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    MSN LIFE SCIENCES PRIVATE LTD

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    USDMF

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    31159
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    APREMILAST (AMORPHOUS)
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    2016-12-23
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    Application Number
    31159
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    Status - Active
    Facility Fees - Paid
    DMF Review - Complete
     
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    APREMILAST (AMORPHOUS)
    Issue/Submission Date
    2016-12-23
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    MSN LIFE SCIENCES PRIVATE LTD

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    USDMF

    Application Number
    30866
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    DMF Review - Complete
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    APREMILAST (FORM-M)
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    2016-08-31
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    Application Number
    30866
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    2016-08-31
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    MSN LIFE SCIENCES PRIVATE LTD

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    USDMF

    Application Number
    30332
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    APREMILAST [ROUTE CODE LI]
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    2016-03-29
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    Application Number
    30332
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    APREMILAST [ROUTE CODE LI]
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    2016-03-29
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    MYLAN LABORATORIES LTD

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    USDMF

    Application Number
    32150
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    APREMILAST (CRYSTALLINE)
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    2017-11-08
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    Application Number
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    APREMILAST (CRYSTALLINE)
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    NEULAND LABORATORIES LTD

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    2018-11-06
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    Olainfarm JSC

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    Omgene Life Sciences Pvt. Ltd

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    QUIMICA SINTETICA SA

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    2017-10-10
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    RAKS PHARMA PVT LTD

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    2016-12-29
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    Srini Pharmaceuticals Ltd.

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    Teva Pharmaceutical Industries Ltd.

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    32373
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    APREMILAST
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    2017-12-22
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    Application Number
    32373
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    2017-12-22
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    ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

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    Application Number
    31882
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    APREMILAST
    Issue/Submission Date
    2017-07-12
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    CEP/COS

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    Issue/Submission Date
    Supporting Info
    Application Number
    31882
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    Status - Active
    Facility Fees - Paid
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    APREMILAST
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    2017-07-12
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    ENANTIOTECH CORP LTD

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    USDMF

    Application Number
    31844
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    Facility Fees - Unpaid
    DMF Review - N/A
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    AMT01 (INTERMEDIATE FOR APREMILAST)
    Issue/Submission Date
    2017-06-15
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    CEP/COS

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    Application Number
    31844
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    Status - Active
    Facility Fees - Unpaid
    DMF Review - N/A
     
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    AMT01 (INTERMEDIATE FOR APREMILAST)
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    2017-06-15
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