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01 3Strides Pharma Science

02 22care4

03 2ARCUTIS CANADA, INC.

04 2Alkem Laboratories

05 3Arcutis Biotherapeutics

06 8AstraZeneca

07 2Aurobindo Pharma Limited

08 2Hetero Drugs

09 1KMS Health Center

10 1MS Pharma

11 2MSN Laboratories

12 2Micro Labs Limited

13 1NORVIUM BIOSCIENCE

14 2ORIFARM GROUP AS

15 1Orchid Pharma

16 1Precise Group

17 1Prinston

18 2Senores Pharmaceuticals

19 4Takeda Pharmaceutical

20 4Torrent Pharmaceuticals Limited

21 2Zydus Pharmaceuticals

22 2Blank

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Regulatory Info : RX

Registration Country : USA

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Packaging :

Approval Date : 2020-03-30

Application Number : 208247

Regulatory Info : RX

Registration Country : USA

Strides Pharma Science

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Regulatory Info : RX

Registration Country : USA

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Packaging :

Approval Date : 2023-06-20

Application Number : 208247

Regulatory Info : RX

Registration Country : USA

Strides Pharma Science

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Regulatory Info :

Registration Country : India

Roflumilast

Brand Name :

Dosage Form : Tablet

Dosage Strength : 500MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

04

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Packaging :

Approval Date : 2023-04-18

Application Number : 212490

Regulatory Info : RX

Registration Country : USA

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05

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Packaging :

Approval Date : 2023-04-18

Application Number : 212490

Regulatory Info : RX

Registration Country : USA

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06

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ZORYVE

Dosage Form : CREAM;TOPICAL

Dosage Strength : 0.3%

Packaging :

Approval Date : 2022-07-29

Application Number : 215985

Regulatory Info : RX

Registration Country : USA

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07

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ZORYVE

Dosage Form : CREAM;TOPICAL

Dosage Strength : 0.15%

Packaging :

Approval Date : 2024-07-09

Application Number : 215985

Regulatory Info : RX

Registration Country : USA

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08

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ZORYVE

Dosage Form : FOAM;TOPICAL

Dosage Strength : 0.3%

Packaging :

Approval Date : 2023-12-15

Application Number : 217242

Regulatory Info : RX

Registration Country : USA

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09

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : DALIRESP

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Packaging :

Approval Date : 2011-02-28

Application Number : 22522

Regulatory Info : RX

Registration Country : USA

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10

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : DALIRESP

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Packaging :

Approval Date : 2018-01-23

Application Number : 22522

Regulatory Info : RX

Registration Country : USA

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11

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Packaging :

Approval Date : 2023-04-17

Application Number : 213298

Regulatory Info : RX

Registration Country : USA

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12

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Packaging :

Approval Date : 2025-01-31

Application Number : 213298

Regulatory Info : RX

Registration Country : USA

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13

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Packaging :

Approval Date : 2018-11-23

Application Number : 208213

Regulatory Info : RX

Registration Country : USA

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14

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Packaging :

Approval Date : 2023-04-18

Application Number : 208213

Regulatory Info : RX

Registration Country : USA

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15

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Packaging :

Approval Date : 2019-03-22

Application Number : 208180

Regulatory Info : RX

Registration Country : USA

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16

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Packaging :

Approval Date : 2023-04-18

Application Number : 208180

Regulatory Info : RX

Registration Country : USA

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17

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

Roflumilast

Brand Name :

Dosage Form : TABLET

Dosage Strength : 500MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic CTD, BE- Available

Registration Country : Jordan

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18

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Packaging :

Approval Date : 2022-09-07

Application Number : 208256

Regulatory Info : RX

Registration Country : USA

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19

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Packaging :

Approval Date : 2022-09-07

Application Number : 208256

Regulatory Info : RX

Registration Country : USA

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20

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

Roflumilast

Brand Name :

Dosage Form : TABLET

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic EU CTD

Registration Country : India

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21

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Packaging :

Approval Date : 2022-05-10

Application Number : 208299

Regulatory Info : RX

Registration Country : USA

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22

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Packaging :

Approval Date : 2018-10-03

Application Number : 208236

Regulatory Info : DISCN

Registration Country : USA

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23

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Packaging :

Approval Date : 2023-10-19

Application Number : 208236

Regulatory Info : DISCN

Registration Country : USA

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24

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

roflumilast

Brand Name : Daliresp

Dosage Form : FILM COATED PILL

Dosage Strength : 500 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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25

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

roflumilast

Brand Name : Daxas

Dosage Form : FILM COATED PILL

Dosage Strength : 500 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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26

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Packaging :

Approval Date : 2018-08-06

Application Number : 208272

Regulatory Info : DISCN

Registration Country : USA

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27

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Packaging :

Approval Date : 2024-10-18

Application Number : 208272

Regulatory Info : RX

Registration Country : USA

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28

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Packaging :

Approval Date : 2022-02-10

Application Number : 208303

Regulatory Info : RX

Registration Country : USA

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29

Peptide Therapy Summit
Not Confirmed
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Packaging :

Approval Date : 2023-04-18

Application Number : 208303

Regulatory Info : RX

Registration Country : USA

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30

NORVIUM BIOSCIENCE

Country
Peptide Therapy Summit
Not Confirmed
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NORVIUM BIOSCIENCE

Country
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Peptide Therapy Summit
Not Confirmed

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Packaging :

Approval Date : 2018-07-13

Application Number : 208257

Regulatory Info : RX

Registration Country : USA

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