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

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01 4Sanofi

02 3Orion Corporation

03 6Alfred E Tiefenbacher GmbH

04 1Breckenridge Pharmaceutical

05 3Octavius Pharma Pvt. Ltd

06 3Pharmathen SA

07 6Strides Pharma Science

08 3Towa Pharmaceutical

09 4ADDENDA PHARMA Srl

10 3AGIPS FARMACEUTICI Srl

11 1ALTER LABORATORIES SRL

12 1ANGENERICO SpA

13 1ANGITA PHARMA INC.

14 3Abdi Ibrahim

15 12Accord healthcare

16 3Acromax

17 12Actavis Inc

18 3Adamed Pharma

19 6Adcock Ingram

20 4Aeon Formulations Private Limited

21 1Agips Farmaceutici

22 4Ajanta Pharma Limited

23 3Akacia Healthcare

24 3Alphapharm PTY Ltd

25 3Amneal Pharmaceuticals

26 3Anbison

27 1Apotex Fermentation Inc.

28 7Apotex Inc

29 2Arrow Pharmaceuticals

30 1Ascend Labs

31 2Aspire Lifesciences Pvt Ltd

32 3Auro Pharma Inc

33 13Aurobindo Pharma Limited

34 1BB FARMA Srl

35 2BB Farma

36 1BIOMED 2002 INC

37 8Bio Labs

38 3Biofarma Pharmaceutical Industry and Commerce Inc

39 3Biotech Laboratories Pty Ltd

40 2C.T. LAB.FARMACEUTICO Srl

41 3Camox Pharmaceuticals

42 3Chartwell Pharmaceuticals llc

43 1Cipla

44 3Cipla Medpro South Africa

45 6DOC Generici

46 2Dorsa Darou Pharmaceutical Company

47 6Dr Reddy's Laboratories (Pty) Ltd

48 2EG SpA

49 2EG Spa

50 3ELLEVA PHARMA SRL

51 2ERREKAPPA EUROTERAPICI SpA

52 1Eloge

53 3Eurofarma Laboratorios S.A

54 1FARMA 1000 SRL

55 1FARMA 1000 Srl

56 6Farm Agon

57 2Fulton Medicinali S.p.A

58 1GENERAL PHARMA SOLUTIONS SpA

59 2GENETIC SpA

60 3GERMED PHARMA Srl

61 1GMM FARMA Srl

62 3GMM Farma

63 1General Pharma

64 2Generic Health

65 1Genetic Spa

66 6Glenmark Pharmaceuticals

67 3Grupo Azevedos

68 1Grupo Chemo

69 3Hetero Drugs

70 3Hikma Pharmaceuticals

71 1Holden Medical Laboratories Pvt. Ltd

72 5Humanis

73 3IBN Savio

74 1INTEGRATED HEALTH PROGRAMS SRL

75 2IST.CHIM.INTERNAZ. RENDE Srl

76 1Indoco Remedies Limited

77 3Intas Pharmaceuticals

78 3JAMP PHARMA

79 1Jeil Pharmaceutical Co., Ltd

80 2Jubilant Generics

81 3KONPHARMA Srl

82 3KRKA Sverige AB

83 3Konpharma

84 6Krka

85 1Kusum Healthcare Pvt Ltd

86 1LABORATOIRE RIVA INC.

87 3LHC Pharmaceuticals (Pty) Ltd

88 1Laboratorios Alter

89 2Lannett Company, Inc.

90 2Lucent Biotech Ltd

91 1MANTRA PHARMA INC

92 1MARCAN PHARMACEUTICALS INC

93 3MINT PHARMACEUTICALS INC

94 3MS Pharma

95 7Macleods Pharmaceuticals Limited

96 1Medifarm Italia

97 7Mepha Pharma

98 20Merck & Co

99 3Myungmoon Pharm. Co., LTD.

100 4NEOPHARMED GENTILI Srl

101 2NORVIUM BIOSCIENCE

102 2Natco Pharma

103 3Natco Pharma (Canada) Inc

104 3Neopharma

105 3Neopharmed Gentili

106 3Neuraxpharm

107 4Nobel Ilac Sanayii Ve Ticaret A.S.

108 1Nora Pharma

109 1Northern Medical Group ApS

110 4ORGANON CANADA INC.

111 7ORIFARM GROUP AS

112 24Organon

113 6Organon South Africa (Pty) Ltd

114 3PIAM Farmaceutici S.p.A

115 3PRO DOC LIMITEE

116 1PROGRAMMI SANIT.INTEGRATI Srl

117 6Pensa Pharma

118 1Perrigo Company plc

119 3Pharma Dynamics

120 2Pharmacare Premium

121 4Pharmachim AB

122 6Pharmascience Inc.

123 2Pluviaendo

124 1Precise Group

125 4RANBAXY LABORATORIES LIMITED

126 1RELIANCE FORMULATION PVT. LTD

127 3RISING PHARMA

128 1Raptakos Brett

129 5Remedy Pharma

130 1Riyadh Pharma

131 5S.F.GROUP Srl

132 2SANIS HEALTH INC

133 3SIVEM PHARMACEUTICALS ULC

134 3SO.SE.PHARM Srl

135 3STADA Arzneimittel

136 34Sandoz B2B

137 1Saudi Pharmaceutical Industries & Medical Appliances

138 3Seoul Pharma Co Ltd

139 1Smith & Kenner Pharmaceuticals

140 3So.Se.Pharm

141 3Specpharm

142 8Spirig Healthcare

143 1Stellapharm

144 2Sun Pharmaceutical Industries Limited

145 1TECNIMEDE SOC.TECNICO-MED.S.A.

146 2Tecnimede

147 24Teva Pharmaceutical Industries

148 11Torrent Pharmaceuticals Limited

149 1Towa Pharma

150 3Trinity Pharmaceuticals

151 7Unichem Laboratories Limited

152 3Unichem Pharmaceuticals USA, Inc

153 3Unimark Remedies Limited

154 1Vaishali Pharma Ltd

155 8Viatris

156 1Wanbang Biopharmaceuticals

157 6World Medicine

158 3XL Laboratories Private Limited

159 4XYZ Pharma

160 1Xepa-Soul Pattinson m SDN BHD

161 6Zentiva

162 17Zim Laboratories

163 1Zota Healthcare Ltd

164 6Zydus Lifesciences

165 90Blank

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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

Montelukast

Brand Name : Montelukast Helvepharm

Dosage Form : Film-Coated Tablets

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

02

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Luxepack
Not Confirmed

montelukastnatrium

Brand Name : Montelukast Orion

Dosage Form : TUGGTABLETT

Dosage Strength : 5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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

MONTELUKAST SODIUM

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

04

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Luxepack
Not Confirmed

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Packaging :

Approval Date : 2020-10-30

Application Number : 205319

Regulatory Info : DISCN

Registration Country : USA

Breckenridge Pharmaceutical

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 :

Registration Country : India

Montelukast Sodium

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

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

Montelukast Sodium

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

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 : DISCN

Registration Country : USA

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Packaging :

Approval Date : 2012-08-03

Application Number : 91576

Regulatory Info : DISCN

Registration Country : USA

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

Montelukast

Brand Name : MONTELUKAST THINK

Dosage Form : Coated Tablets

Dosage Strength : 10 mg

Packaging : 28 UNITS 10 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

Montelukast

Brand Name : Montelukast Helvepharm

Dosage Form : Film-Coated Tablets

Dosage Strength : 10mg

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

Montelukast

Brand Name : Montelukast Zentiva

Dosage Form : Filmtabl

Dosage Strength : 10mg

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

Montelukast

Brand Name : Montelukast Zentiva

Dosage Form : Filmtabl

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

12

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Luxepack
Not Confirmed

montelukastnatrium

Brand Name : Montelukast Orion

Dosage Form : TABLETT

Dosage Strength : 10 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

13

arrow
Luxepack
Not Confirmed

montelukastnatrium

Brand Name : Montelukast Orion

Dosage Form : TUGGTABLETT

Dosage Strength : 4 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

14

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Registered in EU

Registration Country : Germany

MONTELUKAST SODIUM

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

15

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Registered in EU

Registration Country : Germany

MONTELUKAST SODIUM

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

16

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Registered in EU

Registration Country : Germany

MONTELUKAST SODIUM

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

17

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Registered in EU

Registration Country : Germany

MONTELUKAST SODIUM

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

18

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Registered in EU

Registration Country : Germany

MONTELUKAST SODIUM

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

19

  • 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

Montelukast Sodium

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

20

  • 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

Montelukast Sodium

Brand Name :

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma