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List of All Manufacturers & Suppliers of DSSTox_CID_3177 Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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01 4Dr. Reddy's Laboratories

02 5Douglas CDMO

03 7Pharmathen SA

04 3Strides Pharma Science

05 42care4 ApS

06 4Acino Pharma (Pty) Ltd

07 8Actavis Inc

08 2Adcock Ingram

09 4Amneal Pharmaceuticals

10 2Apotex Inc

11 3Arrow Pharmaceuticals

12 6Aurobindo Pharma Limited

13 2Austell Laboratories

14 2Bahrain Pharma

15 4CIPHER PHARMS INC

16 1Chongqing Huapont Pharmaceutical

17 2Cipla Medpro South Africa

18 2DIFA COOPER SpA

19 4Difa Cooper

20 1Drossapharm

21 6Ebb Medical AB

22 10F. Hoffmann-La Roche

23 4Fidia Farmaceutici Spa

24 1GSK

25 2Generic Health

26 2ISDIN

27 2ISDIN Srl

28 4Madras Pharmaceuticals

29 8Mepha Pharma

30 5ORIFARM GROUP AS

31 2Oraderm

32 1Pharmacore Inc

33 11Pierre Fabre

34 1Raha Pharmaceutical Co

35 6Recordati

36 9Sandoz B2B

37 3Stiefel

38 20Sun Pharmaceutical Industries Limited

39 4Teva Pharmaceutical Industries

40 8Upsher-Smith Laboratories

41 2VELIT BIOPHARMA SRL

42 5Viatris

43 2World Medicine

44 2XL Laboratories Private Limited

45 4XYZ Pharma

46 4Zydus Pharmaceuticals

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Isotretinoin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDouglas CDMO develops, manufactures, and packs various dosage forms, and provides regulatory support for international distribution.

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Douglas CDMO

03

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AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info : EU Approved

Registration Country : Greece

Isotretinoin

Brand Name :

Dosage Form : Soft Gel Capsule

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

Pharmathen

04

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : Australia

isotretinoin

Brand Name : Dermatane

Dosage Form : capsule

Dosage Strength : 40 mg

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Strides Pharma Science

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Isotretinoin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Isotretinoin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Isotretinoin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDouglas CDMO develops, manufactures, and packs various dosage forms, and provides regulatory support for international distribution.

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Douglas CDMO

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDouglas CDMO develops, manufactures, and packs various dosage forms, and provides regulatory support for international distribution.

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Douglas CDMO

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDouglas CDMO develops, manufactures, and packs various dosage forms, and provides regulatory support for international distribution.

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Douglas CDMO

11

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDouglas CDMO develops, manufactures, and packs various dosage forms, and provides regulatory support for international distribution.

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Douglas CDMO

12

arrow
AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info : EU Approved

Registration Country : Greece

Isotretinoin

Brand Name :

Dosage Form : Soft Gel Capsule

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

Pharmathen

13

arrow
AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info : EU Approved

Registration Country : Greece

Isotretinoin

Brand Name :

Dosage Form : Soft Gel Capsule

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

Pharmathen

14

arrow
AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info : USA

Registration Country : Greece

Isotretinoin

Brand Name :

Dosage Form : Capsule

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

15

arrow
AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info : USA

Registration Country : Greece

Isotretinoin

Brand Name :

Dosage Form : Capsule

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

16

arrow
AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info : USA

Registration Country : Greece

Isotretinoin

Brand Name :

Dosage Form : Capsule

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

17

arrow
AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info : USA

Registration Country : Greece

Isotretinoin

Brand Name :

Dosage Form : Capsule

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

18

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : Australia

isotretinoin

Brand Name : Dermatane

Dosage Form : capsule

Dosage Strength : 10 mg

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Strides Pharma Science

19

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : Australia

isotretinoin

Brand Name : Dermatane

Dosage Form : capsule

Dosage Strength : 20 mg

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Strides Pharma Science

20

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

ISOTRETINOIN

Brand Name : ACCUTANE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-05-07

Application Number : 18662

Regulatory Info : DISCN

Registration Country : USA

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