CAS-151767-02-1 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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CAS-151767-02-1
FDA Orange Book

PharmaCompass Sponsored Ads

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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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Montelukast Sodium

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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pharmacompass-2-m-2025-08-25

CAS-151767-02-1

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

99 API Suppliers, 29 USDMF, 19 CEP/COS, 20 JDMF, 21 EU WC, 26 KDMF, 17 NDC API, 53 Listed Suppliers, $ API Reference Price

99 API Suppliers
29 USDMF
19 CEP/COS
20 JDMF
21 EU WC
26 KDMF
17 NDC API
53 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

91 Drugs in Development

91 Drugs in Development

INTERMEDIATES

32 Intermediate Suppliers

32 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

745 FDF Dossiers, 73 FDA Orange Book, 368 Europe, 48 Canada, 32 Australia, 73 South Africa, 151 Listed Dossiers

745 FDF Dossiers
73 FDA Orange Book
368 Europe
48 Canada
32 Australia
73 South Africa
151 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 Co-Processed Excipients, 12 Parenteral, 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 Co-Processed Excipients
12 Parenteral
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, 334 Regulatory FDF Prices, 11 Annual Reports

22 US Medicaid Prescriptions
334 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, 10 Others

4 EDQM
3 USP
10 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,025 Xls

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73 All

01 1BRECKENRIDGE

02 1STRIDES PHARMA

03 3UNIMARK REMEDIES LTD

04 1ACCORD HLTHCARE

05 4AJANTA PHARMA LTD

06 3AMNEAL PHARMS

07 3ANBISON LAB

08 1APOTEX CORP

09 2APOTEX INC

10 4AUROBINDO PHARMA LTD

11 3CHARTWELL MOLECULAR

12 1CIPLA

13 2DR REDDYS LABS LTD

14 1GLENMARK PHARMS LTD

15 3HETERO LABS LTD V

16 3HIKMA

17 2JUBILANT GENERICS

18 1L PERRIGO CO

19 2LANNETT CO INC

20 3MACLEODS PHARMS LTD

21 2NATCO PHARMA

22 2NEW HEIGHTSRX

23 1NORVIUM BIOSCIENCE

24 4ORGANON

25 1PHARMOBEDIENT

26 3RISING

27 3SANDOZ INC

28 2SENORES PHARMS

29 4TEVA PHARMS

30 1TORRENT

31 3TORRENT PHARMS LTD

32 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 26DISCN

02 47RX

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

Peptide Process CMC

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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

Portfolio PDF

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Corporate PDF

02

STRIDES PHARMA

CPhI WW Frankfurt

Booth # 9.1F6 & 9.1G41

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

UNIMARK REMEDIES LTD

Peptide Process CMC

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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 : 2014-10-30

Application Number : 202859

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

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Corporate PDF

04

UNIMARK REMEDIES LTD

Peptide Process CMC

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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 : 2014-10-30

Application Number : 203037

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

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Corporate PDF

05

UNIMARK REMEDIES LTD

Peptide Process CMC

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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 : 2014-10-30

Application Number : 203037

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

ORGANON

Peptide Process CMC

Not Confirmed

ORGANON

Peptide Process CMC

Not Confirmed

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Digital Content

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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07

ORGANON

Peptide Process CMC

Not Confirmed

ORGANON

Peptide Process CMC

Not Confirmed

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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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Corporate PDF

08

ORGANON

Peptide Process CMC

Not Confirmed

ORGANON

Peptide Process CMC

Not Confirmed

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Digital Content

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

Portfolio PDF

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09

ORGANON

Peptide Process CMC

Not Confirmed

ORGANON

Peptide Process CMC

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

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10

TEVA PHARMS

Peptide Process CMC

Not Confirmed

TEVA PHARMS

Peptide Process CMC

Not Confirmed

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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

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Product Web Link

Digital Content

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