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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 3Captavis Biocare

17 1Chongqing Huapont Pharmaceutical

18 2Cipla Medpro South Africa

19 2DIFA COOPER SpA

20 2Deurali-Janta Pharmaceuticals

21 4Difa Cooper

22 1Drossapharm

23 6Ebb Medical AB

24 10F. Hoffmann-La Roche

25 4Fidia Farmaceutici Spa

26 1GSK

27 2Generic Health

28 2ISDIN

29 2ISDIN Srl

30 4Madras Pharmaceuticals

31 8Mepha Pharma

32 5ORIFARM GROUP AS

33 2Oraderm

34 1Pharmacore Inc

35 11Pierre Fabre

36 1Raha Pharmaceutical Co

37 6Recordati

38 9Sandoz B2B

39 3Stiefel

40 20Sun Pharmaceutical Industries Limited

41 4Teva Pharmaceutical Industries

42 8Upsher-Smith Laboratories

43 2VELIT BIOPHARMA SRL

44 6Viatris

45 2WAGNER PHARMACEUTICALS PTY LTD

46 2World Medicine

47 2XL Laboratories Private Limited

48 4XYZ Pharma

49 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 BoothEnd-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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

  • 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 BoothEnd-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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 BoothEnd-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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 BoothEnd-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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 BoothEnd-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Cophex
Not Confirmed
arrow
arrow
Cophex
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

blank

21

Cophex
Not Confirmed
arrow
arrow
Cophex
Not Confirmed

ISOTRETINOIN

Brand Name : ACCUTANE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 40MG **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

blank

22

Cophex
Not Confirmed
arrow
arrow
Cophex
Not Confirmed

ISOTRETINOIN

Brand Name : ACCUTANE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1983-03-28

Application Number : 18662

Regulatory Info : DISCN

Registration Country : USA

blank

23

Cophex
Not Confirmed
arrow
arrow
Cophex
Not Confirmed

ISOTRETINOIN

Brand Name : ABSORICA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2012-05-25

Application Number : 21951

Regulatory Info : RX

Registration Country : USA

blank

24

Cophex
Not Confirmed
arrow
arrow
Cophex
Not Confirmed

ISOTRETINOIN

Brand Name : ABSORICA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2012-05-25

Application Number : 21951

Regulatory Info : RX

Registration Country : USA

blank

25

Cophex
Not Confirmed
arrow
arrow
Cophex
Not Confirmed

ISOTRETINOIN

Brand Name : ABSORICA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 2012-05-25

Application Number : 21951

Regulatory Info : RX

Registration Country : USA

blank

26

Cophex
Not Confirmed
arrow
arrow
Cophex
Not Confirmed

ISOTRETINOIN

Brand Name : ABSORICA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 40MG

Packaging :

Approval Date : 2012-05-25

Application Number : 21951

Regulatory Info : RX

Registration Country : USA

blank

27

Cophex
Not Confirmed
arrow
arrow
Cophex
Not Confirmed

ISOTRETINOIN

Brand Name : ABSORICA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2014-08-15

Application Number : 21951

Regulatory Info : RX

Registration Country : USA

blank

28

Cophex
Not Confirmed
arrow
arrow
Cophex
Not Confirmed

ISOTRETINOIN

Brand Name : ABSORICA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 35MG

Packaging :

Approval Date : 2014-08-15

Application Number : 21951

Regulatory Info : RX

Registration Country : USA

blank

29

Cophex
Not Confirmed
arrow
arrow
Cophex
Not Confirmed

ISOTRETINOIN

Brand Name : AMNESTEEM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2002-11-08

Application Number : 75945

Regulatory Info : RX

Registration Country : USA

blank

30

Cophex
Not Confirmed
arrow
arrow
Cophex
Not Confirmed

ISOTRETINOIN

Brand Name : AMNESTEEM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2002-11-08

Application Number : 75945

Regulatory Info : RX

Registration Country : USA

blank