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Montelukast Sodium Salt
FDA Orange Book

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Montelukast Sodium

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Montelukast Sodium

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Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

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pharmacompass-2-m-2025-11-03

Montelukast sodium salt

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ACTIVE PHARMA INGREDIENTS

98 API Suppliers, 29 USDMF, 19 CEP/COS, 20 JDMF, 18 EU WC, 27 KDMF, 17 NDC API, 54 Listed Suppliers, $ API Reference Price

98 API Suppliers
29 USDMF
19 CEP/COS
20 JDMF
18 EU WC
27 KDMF
17 NDC API
54 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

84 Drugs in Development

84 Drugs in Development

INTERMEDIATES

32 Intermediate Suppliers

32 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

745 FDF Dossiers, 73 FDA Orange Book, 372 Europe, 48 Canada, 24 Australia, 81 South Africa, 147 Listed Dossiers

745 FDF Dossiers
73 FDA Orange Book
372 Europe
48 Canada
24 Australia
81 South Africa
147 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET, CHEWABLE;ORAL - EQ 4MG BASE, TABLET, CHEWABLE;ORAL - EQ 5MG BASE, GRANULE;ORAL - EQ 4MG BASE/PACKET

TABLET;ORAL - EQ 10MG BASE
TABLET, CHEWABLE;ORAL - EQ 4MG BASE
TABLET, CHEWABLE;ORAL - EQ 5MG BASE
GRANULE;ORAL - EQ 4MG BASE/PACKET

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Rochem International Inc, 19 SPI Pharma, 13 DKSH, 1 Pharm-RX Chemical, 2 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 2 Kirsch Pharma, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 20 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 2 Finar, 7 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 25 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

76 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 41 Direct Compression, 33 Disintegrants & Superdisintegrants, 32 Granulation, 26 Thickeners and Stabilizers, 25 Taste Masking, 24 Controlled & Modified Release, 23 Lubricants & Glidants, 20 Chewable & Orodispersible Aids, 16 Topical, 13 Film Formers & Plasticizers, 13 Solubilizers, 12 Parenteral, 12 Co-Processed Excipients, 6 Rheology Modifiers, 5 Empty Capsules, 5 API Stability Enhancers, 5 Coloring Agents, 5 Emulsifying Agents, 4 Vegetarian Capsules, 2 Surfactant & Foaming Agents

76 Fillers, Diluents & Binders
49 Coating Systems & Additives
41 Direct Compression
33 Disintegrants & Superdisintegrants
32 Granulation
26 Thickeners and Stabilizers
25 Taste Masking
24 Controlled & Modified Release
23 Lubricants & Glidants
20 Chewable & Orodispersible Aids
16 Topical
13 Film Formers & Plasticizers
13 Solubilizers
12 Parenteral
12 Co-Processed Excipients
6 Rheology Modifiers
5 Empty Capsules
5 API Stability Enhancers
5 Coloring Agents
5 Emulsifying Agents
4 Vegetarian Capsules
2 Surfactant & Foaming Agents

DIGITAL CONTENT

46 News #PharmaBuzz

46 News #PharmaBuzz

GLOBAL SALES INFORMATION

22 US Medicaid Prescriptions, 207 Regulatory FDF Prices, 11 Annual Reports

22 US Medicaid Prescriptions
207 Regulatory FDF Prices
11 Annual Reports

MARKET PLACE

53 APIs, 7 FDF Dossiers, 1 Intermediates

53 APIs
7 FDF Dossiers
1 Intermediates

PATENTS & EXCLUSIVITIES

8 Health Canada Patents

8 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 12 Others

4 EDQM
3 USP
12 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,016 Xls

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73 All

01 1BRECKENRIDGE

02 1STRIDES PHARMA INTL

03 1ACCORD HLTHCARE

04 2AIPING PHARM INC

05 4AJANTA PHARMA LTD

06 3AMNEAL PHARMS

07 3ANBISON LAB

08 2ANDA REPOSITORY

09 1APOTEX CORP

10 2APOTEX INC

11 4AUROBINDO PHARMA LTD

12 3CHARTWELL MOLECULAR

13 1CIPLA

14 2DR REDDYS LABS LTD

15 1GLENMARK PHARMS LTD

16 3HETERO LABS LTD V

17 3HIKMA

18 2JUBILANT GENERICS

19 1L PERRIGO CO

20 2LANNETT CO INC

21 3MACLEODS PHARMS LTD

22 2NATCO PHARMA

23 4ORGANON

24 2PHARMACO

25 5PHARMOBEDIENT

26 3RISING

27 1SANDOZ INC

28 4TEVA PHARMS

29 1TORRENT

30 3TORRENT PHARMS LTD

31 3UNICHEM

filter Dosage Reset all filters

73 All

01 7GRANULE;ORAL

02 42TABLET, CHEWABLE;ORAL

03 24TABLET;ORAL

filter Regulatory Info Reset all filters

73 All

01 23DISCN

02 50RX

filter Brand Name Reset all filters

73 All

01 69MONTELUKAST SODIUM

02 4SINGULAIR

filter RLD Reset all filters

73 All

01 69No

02 4Yes

Montelukast Sodium

List of Suppliers

Product Main Page

01

BRECKENRIDGE

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Digital Content

RLD : No

TE Code :

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2020-10-30

Application Number : 205319

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Breckenridge Pharmaceutical

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Digital Content

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02

STRIDES PHARMA INTL

Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

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Digital Content

RLD : No

TE Code :

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2012-08-03

Application Number : 91576

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

Product Web Link

Digital Content

03

ORGANON

AES

Not Confirmed

ORGANON

AES

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RLD : Yes

TE Code : AB

MONTELUKAST SODIUM

Brand Name : SINGULAIR

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 1998-02-20

Application Number : 20829

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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Digital Content

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04

ORGANON

AES

Not Confirmed

ORGANON

AES

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Digital Content

RLD : Yes

TE Code : AB

MONTELUKAST SODIUM

Brand Name : SINGULAIR

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 1998-02-20

Application Number : 20830

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

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Digital Content

Corporate PDF

05

ORGANON

AES

Not Confirmed

ORGANON

AES

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RLD : Yes

TE Code : AB

MONTELUKAST SODIUM

Brand Name : SINGULAIR

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : EQ 4MG BASE

Approval Date : 2000-03-03

Application Number : 20830

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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Digital Content

Corporate PDF

06

ORGANON

AES

Not Confirmed

ORGANON

AES

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Digital Content

RLD : Yes

TE Code : AB

MONTELUKAST SODIUM

Brand Name : SINGULAIR

Dosage Form : GRANULE;ORAL

Dosage Strength : EQ 4MG BASE/PACKET

Approval Date : 2002-07-26

Application Number : 21409

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

TEVA PHARMS

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TEVA PHARMS

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Digital Content

RLD : No

TE Code : AB

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2012-08-03

Application Number : 78605

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

TEVA PHARMS

AES

Not Confirmed

TEVA PHARMS

AES

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Digital Content

RLD : No

TE Code : AB

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : EQ 4MG BASE

Approval Date : 2012-08-03

Application Number : 78723

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

TEVA PHARMS

AES

Not Confirmed

TEVA PHARMS

AES

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2012-08-03

Application Number : 78723

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

PHARMOBEDIENT

Country

AES

Not Confirmed

PHARMOBEDIENT

Country

AES

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Digital Content

RLD : No

TE Code :

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2012-08-03

Application Number : 79103

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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