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

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01 16Sanofi

02 17Orion Corporation

03 10Alfred E Tiefenbacher GmbH

04 4Douglas CDMO

05 2Octavius Pharma Pvt. Ltd

06 6Pharmathen SA

07 14Strides Pharma Science

08 2Towa Pharmaceutical

09 51A Farma A / S,

10 2ALTER LABORATORIES SRL

11 10ANGITA PHARMA INC.

12 64Accord healthcare

13 20Actavis Inc

14 4Adcock Ingram

15 6Alembic Pharmaceuticals Limited

16 7Alkem Laboratories

17 13Alphapharm PTY Ltd

18 10Amneal Pharmaceuticals

19 22Apotex Inc

20 13Arrow Pharmaceuticals

21 4Ascend Labs

22 82AstraZeneca

23 4Auro Pharma Inc

24 27Aurobindo Pharma Limited

25 4Aurogen South Africa (Pty) Ltd

26 1BIOMED 2002 INC

27 5Biotech Laboratories Pty Ltd

28 32CPS Cito Pharma Services GmbH

29 3Centurion Laboratories

30 10Cheplapharm Arzneimittel Gmbh

31 4Cipla Medpro South Africa

32 1Cooper Pharma Limited

33 3Cristalia Produtos Quimicos Farma. Ltda

34 16Cross Pharma AB

35 20DOC Generici

36 4Deva Holding AS

37 8Dr Reddy's Laboratories (Pty) Ltd

38 10EG SpA

39 10EG Spa

40 9ENDO OPERATIONS

41 7Ebb Medical AB

42 6FAIR WITH HEALTHCARE GmbH

43 1FAIRMED HEALTHCARE GMBH

44 2Fairmed Healthcare

45 2Farm Agon

46 5Farmaprojects S.A.U

47 3Future Pharma

48 4Hanlim Pharmaceuticals Inc

49 6Hetero Drugs

50 5Hexal AG

51 6Hikma Pharmaceuticals

52 6Humanis

53 2Ind Swift Laboratories Limited

54 11Intas Pharmaceuticals

55 5Intellipharmaceutics Corporation

56 6Ipca Laboratories

57 13JAMP PHARMA

58 1Jubilant Generics

59 12KRKA Sweden AB

60 17Krka

61 4LABORATOIRE RIVA INC.

62 3Laboratorio Vannier

63 1Laboratorios Alter

64 11Lupin Ltd

65 5MANTRA PHARMA INC

66 9MINT PHARMACEUTICALS INC

67 5MS Pharma

68 19Macleods Pharmaceuticals Limited

69 16Mepha Pharma

70 4Myungmoon Pharm. Co., LTD.

71 1NORVIUM BIOSCIENCE

72 5Natco Pharma

73 5Natco Pharma (Canada) Inc

74 3Neopharma

75 11Neuraxpharm

76 6Nora Pharma

77 5Novast Laboratories

78 38ORIFARM GROUP AS

79 11Omnia Pharmaceutical AB

80 6Orchid Pharma

81 9PRO DOC LIMITEE

82 5Pantson Pharma Pvt. Limited

83 4Paranova Group AS

84 5Pharma Dynamics

85 4Pharmacore Inc

86 10Pharmadax

87 10Pharmascience Inc.

88 11Prinston

89 4RANBAXY LABORATORIES LIMITED

90 3RELIANCE FORMULATION PVT. LTD

91 5RISING PHARMA

92 5Riyadh Pharma

93 9SANIS HEALTH INC

94 9SIVEM PHARMACEUTICALS ULC

95 4STADA Arzneimittel

96 79Sandoz B2B

97 5Saudi Pharmaceutical Industries & Medical Appliances

98 5ScieGen Pharmaceuticals

99 5Specpharm

100 23Spirig Healthcare

101 10Sun Pharmaceutical Industries Limited

102 5Teva Pharma Australia

103 47Teva Pharmaceutical Industries

104 25Torrent Pharmaceuticals Limited

105 4Trinity Pharmaceuticals

106 21Unichem Laboratories Limited

107 11Unichem Pharmaceuticals USA, Inc

108 18Viatris

109 4Viatris South Africa (Pty) Ltd

110 4XL Laboratories Private Limited

111 7XYZ Pharma

112 6Zennova Pharma

113 8Zentiva

114 2Zhejiang Hisun Pharmaceutical

115 4Zimbili Pharma CC

116 183Blank

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Quetiapinum

Brand Name : Quetiapin XR Zentiva

Dosage Form : Ret Tabl

Dosage Strength : 150mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

02

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FNCE 2024
Not Confirmed

Quetiapine

Brand Name :

Dosage Form : TABLET

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number : 77380

Regulatory Info : Generic

Registration Country : Canada

Fermion Orion Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : Registered in EU

Registration Country : Germany

Quetiapine Fumarate

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

04

  • 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

Quetiapine

Brand Name :

Dosage Form : TABLET

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Douglas CDMO

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Quetiapine Fumarate

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Octavius Pharma

06

  • 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

Quetiapine Fumarate

Brand Name :

Dosage Form : Prolonged Release Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

Pharmathen

07

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : India

Quetiapine Hemifumarate

Brand Name :

Dosage Form : Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

Regulatory Info :

Registration Country : Italy

Quetiapine

Brand Name : QUETIAPINA THINKS

Dosage Form : Film-Coated Tablets

Dosage Strength : 25 mg

Packaging : 30 UNITS 25 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Towa Pharmaceutical

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Quetiapinum

Brand Name : Quetiapin XR Zentiva

Dosage Form : Ret Tabl

Dosage Strength : 150mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Quetiapinum

Brand Name : Quetiapin XR Zentiva

Dosage Form : Ret Tabl

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

11

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Quetiapinum

Brand Name : Quetiapin XR Zentiva

Dosage Form : Ret Tabl

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

12

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Quetiapinum

Brand Name : Quetiapin XR Zentiva

Dosage Form : Ret Tabl

Dosage Strength : 300mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

13

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Quetiapinum

Brand Name : Quetiapin XR Zentiva

Dosage Form : Ret Tabl

Dosage Strength : 300mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

14

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Quetiapinum

Brand Name : Quetiapin XR Zentiva

Dosage Form : Ret Tabl

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

15

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Quetiapinum

Brand Name : Quetiapine XR Zentiva

Dosage Form : Ret Tabl

Dosage Strength : 400mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

16

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Quetiapinum

Brand Name : Quetiapine XR Zentiva

Dosage Form : Ret Tabl

Dosage Strength : 400mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

17

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Quetiapinum

Brand Name : Quetiapine Zentiva

Dosage Form : Filmtabl

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

18

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Quetiapinum

Brand Name : Quetiapine Zentiva

Dosage Form : Filmtabl

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

19

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Quetiapinum

Brand Name : Quetiapine Zentiva

Dosage Form : Filmtabl

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

20

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Quetiapinum

Brand Name : Quetiapine Zentiva

Dosage Form : Filmtabl

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner