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

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01 3Allergan Aesthetics

02 6LGM Pharma

03 28Aspen Pharmacare Holdings

04 3Dr. Reddy\'s Laboratories

05 1Taro Pharmaceutical Industries

06 8Mikart

07 2Octavius Pharma Pvt. Ltd

08 10Strides Pharma Science

09 8Granules India Limited

10 6Bal Pharma

11 1ABHAI LLC

12 1ALRA

13 2Acino Pharma

14 9Actavis Inc

15 1Adamed Pharma

16 45Adcock Ingram

17 1Aeon Formulations Private Limited

18 6Akacia Healthcare

19 4Alliance Pharmaceutical Company

20 1Alvogen

21 1Angelini Pharma

22 3Aralez Pharmaceuticals

23 4Arya Pharma (Pty) Ltd

24 1Astral Pharma (Pty) Ltd

25 5Atabay

26 2Aurobindo Pharma Limited

27 1Aurolife Pharma LLC

28 1Avery Pharmaceuticals

29 2Bausch & Lomb Incorporated

30 1Bausch Health

31 1Bayer AG

32 3Be-Tabs Pharmaceuticals

33 1Bernofarm Pharmaceutical Company

34 1Bio Labs

35 2BioMatrix Healthcare

36 1Boston Pharma

37 2CHIESI USA INC

38 1Captagel Pharma GmbH

39 1Cifarma

40 11Cipla Medpro South Africa

41 1Cosette Pharma

42 2Eloge

43 1Embiotic Laboratories

44 1Endo International

45 1Farabi Pharmaceutical

46 1Farmak JSC

47 1Forest Laboratories

48 1Fosun Pharmaceutical

49 2Galt Pharmaceuticals

50 3Glumex Pharmaceuticals Mfg. Pvt. Ltd

51 1Grup Farma

52 2Grupo Azevedos

53 1Gulf Drug Company

54 1HALSEY

55 1Haleon

56 10Hikma Pharmaceuticals

57 1Hiral Labs

58 1Humanis

59 1INNOVATA PHARMACEUTICALS

60 2IVAX Pharmaceuticals Inc

61 1Icon Plc

62 2Indoco Remedies Limited

63 1Intas Pharmaceuticals

64 3Jerome Stevens Pharmaceuticals

65 2Key Therapeutics

66 1Kolmar Korea Co., Ltd.

67 2LABORATOIRE RIVA INC.

68 1LARKEN LABS

69 1LEITNER PHARMS

70 2Laboratoires Gilbert

71 4Lannett Company, Inc.

72 5LeBasi Pharmaceuticals CC

73 3Madras Pharmaceuticals

74 7Mallinckrodt Pharmaceuticals

75 7Maxheal Pharmaceuticals (India) Ltd

76 2McNeil Consumer Health

77 1Meda AB

78 3Medicine Developers International CC

79 1Meenaxy Pharma Pvt. Ltd

80 1Merck & Co

81 1Merck Group

82 1Mirror Pharmaceuticals LLC

83 1Myungmoon Pharm. Co., LTD.

84 1Neopharma

85 1Nesher Pharmaceuticals USA LLC

86 1Nobel Ilac Sanayii Ve Ticaret A.S.

87 2Nostrum Laboratories

88 2Novartis Pharmaceuticals Corporation

89 2Novartis South Africa (Pty) Ltd

90 1Novast Laboratories

91 1Nuvo Pharmaceuticals

92 1PURACAP PHARM

93 1Pannon

94 1Perrigo Company plc

95 1Pharmaceutical Contractors

96 1Pharmaco Distribution

97 1Pharmanova

98 7Pharmascience Inc.

99 1Pluviaendo

100 1QUANTUM PHARMICS

101 3Quagen Pharma

102 5RANBAXY LABORATORIES LIMITED

103 2RELIANCE FORMULATION PVT. LTD

104 1Raha Pharmaceutical Co

105 1SHIRE PLC

106 4SOLVAY PHARMA SpA

107 8Sandoz B2B

108 2Senores Pharmaceuticals

109 1Seoul Pharma Co Ltd

110 6Sun Pharmaceutical Industries Limited

111 1Tatchempharmpreparaty

112 12Teva Pharmaceutical Industries

113 1US CHEM

114 1VITA HEALTH PRODUCTS INC

115 1Vaishali Pharma Ltd

116 1Varichem Pharmaceuticals Pvt Ltd

117 1Vega Biotech Pvt. Ltd.

118 1Vintage Pharmaceuticals-Charlotte

119 1West-ward Pharmaceutical Corp

120 1WraSer Pharmaceuticals

121 2XANODYNE PHARM

122 1Xixia Pharmaceuticals (Pty) Ltd

123 3Zim Laboratories

124 1Zota Healthcare Ltd

125 1iNova Pharmaceuticals

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ASPIRIN; BUTALBITAL; CAFFEINE

Brand Name : FIORINAL

Dosage Form : TABLET;ORAL

Dosage Strength : 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1986-04-16

Application Number : 17534

Regulatory Info : DISCN

Registration Country : USA

Abbvie CB

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Regulatory Info : RX

Registration Country : USA

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG;50MG;40MG

Packaging :

Approval Date : 2009-11-16

Application Number : 40885

Regulatory Info : RX

Registration Country : USA

LGM Pharma CB

03

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Caffeine

Brand Name : Flutex Junior Cold & Flu Syrup

Dosage Form : SUS

Dosage Strength : 30mg/5ml

Packaging : 100X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

04

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : RX

Registration Country : USA

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 325MG;50MG;40MG

Packaging :

Approval Date : 1986-03-17

Application Number : 89007

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAs a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

Regulatory Info : DISCN

Registration Country : USA

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Brand Name : ESGIC-PLUS

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG;50MG;40MG

Packaging :

Approval Date : 1996-03-28

Application Number : 40085

Regulatory Info : DISCN

Registration Country : USA

Mikart

06

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : India

Paracetamol; Caffeine; Phenylephrine Hydrochloride; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide

Brand Name :

Dosage Form : Tablet

Dosage Strength : 500MG; 30MG; 10MG; 2MG; 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

07

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : RX

Registration Country : USA

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Dosage Form : TABLET;ORAL

Dosage Strength : 325MG;50MG;40MG

Packaging :

Approval Date : 2003-08-27

Application Number : 40511

Regulatory Info : RX

Registration Country : USA

Strides Pharma Science

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : RX

Registration Country : USA

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Dosage Form : TABLET;ORAL

Dosage Strength : 325MG;50MG;40MG

Packaging :

Approval Date : 2008-12-01

Application Number : 40864

Regulatory Info : RX

Registration Country : USA

Granules India

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

Regulatory Info : Generic

Registration Country : India

Paracetamol; Caffeine

Brand Name : Regamol Extra

Dosage Form : Tablet

Dosage Strength : 500MG; 65MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

BalPharma company banner

10

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ASPIRIN; BUTALBITAL; CAFFEINE

Brand Name : FIORINAL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1986-04-16

Application Number : 17534

Regulatory Info : DISCN

Registration Country : USA

Abbvie CB

11

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ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Brand Name : FIORINAL W/CODEINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 325MG;50MG;40MG;30MG

Packaging :

Approval Date : 1990-10-26

Application Number : 19429

Regulatory Info : DISCN

Registration Country : USA

Abbvie CB

12

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Regulatory Info : RX

Registration Country : USA

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Brand Name : BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 325MG;50MG;40MG;30MG

Packaging :

Approval Date : 2001-11-30

Application Number : 75231

Regulatory Info : RX

Registration Country : USA

LGM Pharma CB

13

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Regulatory Info : RX

Registration Country : USA

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Brand Name : BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 325MG;50MG;40MG;30MG

Packaging :

Approval Date : 2004-06-10

Application Number : 76560

Regulatory Info : RX

Registration Country : USA

LGM Pharma CB

14

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Regulatory Info : RX

Registration Country : USA

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Brand Name : BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG;50MG;40MG;30MG

Packaging :

Approval Date : 2012-07-19

Application Number : 76560

Regulatory Info : RX

Registration Country : USA

LGM Pharma CB

15

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Regulatory Info : DISCN

Registration Country : USA

ASPIRIN; BUTALBITAL; CAFFEINE

Brand Name : BUTALBITAL, ASPIRIN AND CAFFEINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG;50MG;40MG

Packaging :

Approval Date : 2021-10-18

Application Number : 205230

Regulatory Info : DISCN

Registration Country : USA

LGM Pharma CB

16

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Regulatory Info : RX

Registration Country : USA

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Dosage Form : TABLET;ORAL

Dosage Strength : 325MG;50MG;40MG

Packaging :

Approval Date : 2018-10-31

Application Number : 209587

Regulatory Info : RX

Registration Country : USA

LGM Pharma CB

17

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Caffeine

Brand Name : Dequa-Flu

Dosage Form : CAP

Dosage Strength : 30mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

18

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Not Confirmed

Caffeine

Brand Name : Dequa-Flu

Dosage Form : CAP

Dosage Strength : 30mg

Packaging : 500X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

19

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Caffeine

Brand Name : Doloxene Co-65

Dosage Form : CAP

Dosage Strength : 30mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

20

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Not Confirmed

Caffeine

Brand Name : Doloxene Co-65

Dosage Form : CAP

Dosage Strength : 30mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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