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01 6Dr. Reddy's Laboratories

02 5Douglas CDMO

03 7Pharmathen SA

04 62care4

05 4Acino Pharma

06 7Actavis Inc

07 2Adcock Ingram

08 2Alfasigma

09 10Amneal Pharmaceuticals

10 2Apotex Inc

11 5Arrow Pharmaceuticals

12 6Aurobindo Pharma Limited

13 2Austell Laboratories

14 2Bahrain Pharma

15 4CIPHER PHARMS INC

16 5Cantabria Labs

17 3Captavis Biocare

18 1Central Procurement & Supplies Unit

19 4Cheplapharm Arzneimittel Gmbh

20 1Chongqing Huapont Pharmaceutical

21 2Cipla Medpro South Africa

22 2DIFA COOPER SpA

23 2Deurali-Janta Pharmaceuticals

24 4Difa Cooper

25 1Drossapharm

26 6Ebb Medical

27 2Ennogen Healthcare

28 7F. Hoffmann-La Roche

29 4Fidia Farmaceutici Spa

30 2GSK

31 2Generic Health

32 8ISDIN

33 2ISDIN Srl

34 1Inducare Pharmaceuticals & Research Foundation

35 3Karo Pharma

36 4Laboratoires Bailleul

37 4Madras Pharmaceuticals

38 4Mepha Pharma

39 7ORIFARM GROUP AS

40 1Paranova Pharmaceuticals Ab

41 2Pharmaceutical Specialties Centrum Sa

42 1Pharmaco

43 1Pharmacore Inc

44 12Pierre Fabre

45 2Prohealth Limited

46 1Raha Pharmaceutical Co

47 3Recordati

48 9Sandoz B2B

49 3Stiefel

50 20Sun Pharmaceutical Industries Limited

51 4Teva Pharmaceutical Industries

52 1Uab Bijon Medica

53 8Upsher-Smith Laboratories

54 2VELIT BIOPHARMA SRL

55 6Viatris

56 4Vinas

57 2WAGNER PHARMACEUTICALS PTY LTD

58 2World Medicine

59 2XL Laboratories Private Limited

60 4XYZ Pharma

61 10Zydus 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 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

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 : 30MG

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 : 40MG

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 :

Registration Country : Australia

Isotretinoin

Brand Name : Isotretinoin Dr.Reddy's

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Dr Reddy Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : Australia

Isotretinoin

Brand Name : Isotretinoin Dr.Reddy's

Dosage Form : capsule

Dosage Strength : 20 mg

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Dr Reddy Company Banner

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 : 10MG

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 : 20MG

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 : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Douglas CDMO

12

  • 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

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 : 10MG

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 : 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

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 : 10MG

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 : 20MG

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 : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

18

  • 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

19

CPhI India
Not Confirmed
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CPhI India
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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20

CPhI India
Not Confirmed
arrow
arrow
CPhI India
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

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