CAS-151767-02-1 | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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CAS-151767-02-1
South Africa

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.

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Montelukast Sodium

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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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xyz-pharma-m-2025-03-17

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CAS-151767-02-1

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

92 API Suppliers, 33 USDMF, 19 CEP/COS, 20 JDMF, 18 EU WC, 26 KDMF, 17 NDC API, 51 Listed Suppliers, $ API Reference Price

92 API Suppliers
33 USDMF
19 CEP/COS
20 JDMF
18 EU WC
26 KDMF
17 NDC API
51 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

INTERMEDIATES

29 Intermediate Suppliers

29 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

741 FDF Dossiers, 73 FDA Orange Book, 368 Europe, 48 Canada, 32 Australia, 76 South Africa, 144 Listed Dossiers

741 FDF Dossiers
73 FDA Orange Book
368 Europe
48 Canada
32 Australia
76 South Africa
144 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, 4 Rochem International Inc, 19 SPI Pharma, 13 DKSH, 1 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 2 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 8 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 20 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 8 Pluviaendo, 5 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, 12 Sigachi Industries, 2 The Dow Chemical Company, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 36 Direct Compression, 34 Disintegrants & Superdisintegrants, 29 Controlled & Modified Release, 27 Granulation, 26 Taste Masking, 26 Thickeners and Stabilizers, 22 Lubricants & Glidants, 19 Chewable & Orodispersible Aids, 15 Co-Processed Excipients, 14 Topical, 14 Film Formers & Plasticizers, 13 Solubilizers, 11 Parenteral, 6 Rheology Modifiers, 5 API Stability Enhancers, 5 Coloring Agents, 5 Emulsifying Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 2 Surfactant & Foaming Agents

92 Fillers, Diluents & Binders
55 Coating Systems & Additives
36 Direct Compression
34 Disintegrants & Superdisintegrants
29 Controlled & Modified Release
27 Granulation
26 Taste Masking
26 Thickeners and Stabilizers
22 Lubricants & Glidants
19 Chewable & Orodispersible Aids
15 Co-Processed Excipients
14 Topical
14 Film Formers & Plasticizers
13 Solubilizers
11 Parenteral
6 Rheology Modifiers
5 API Stability Enhancers
5 Coloring Agents
5 Emulsifying Agents
5 Empty Capsules
4 Vegetarian Capsules
2 Surfactant & Foaming Agents

DIGITAL CONTENT

46 News #PharmaBuzz

46 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 334 Regulatory FDF Prices, 10 Annual Reports

2 US Medicaid Prescriptions
334 Regulatory FDF Prices
10 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, 4 USP, 10 Others

4 EDQM
4 USP
10 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,101 Xls

Filters

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76 All

01 3Accord Healthcare (Pty) Ltd

02 6Adcock Ingram Limited

03 3Akacia Health Care (Pty) Ltd

04 1Ascend Laboratories (Pty) Ltd

05 3Biotech Laboratories (Pty) Ltd

06 3Camox Pharmaceuticals (Pty) Ltd

07 3Cipla Medpro (Pty) Ltd

08 6Dr Reddy's Laboratories (Pty) Ltd

09 5Glenmark Pharmaceuticals South Africa (Pty) Ltd

10 3LHC Pharmaceuticals (Pty) Ltd

11 2MSD (Pty) Ltd

12 3Macleods Pharmaceuticals SA (Pty) Ltd

13 9Organon South Africa (Pty) Ltd

14 3Pharma Dynamics (Pty) Ltd

15 3Ranbaxy Pharmaceuticals (Pty) Ltd

16 8Sandoz SA (Pty) Ltd

17 3Specpharm (Pty) Ltd

18 3Trinity Pharma (Pty) Ltd

19 6Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

76 All

01 56Montelukast

02 11Montelukast Sodium

03 6Montelukast sodium

04 3montelukast

filter Dosage Form Reset all filters

76 All

01 32CHU

02 9FCT

03 4GRA

04 31TAB

filter Brand Name Reset all filters

76 All

01 3Airathon

02 1Astelair 10

03 1Astelair 4

04 1Astelair 5

05 1Belair 4mg

06 1Belair 5mg

07 1Belair10mg

08 1Dilair 10

09 1Dilair 4

10 1Dilair 5

11 2Glemolev

12 1Glenmont 10

13 1Glenmont 4

14 1Glenmont 5

15 2Kulair 10

16 2Kulair 4

17 2Kulair 5

18 2Lumont 10 mg

19 2Lumont 4 mg

20 2Lumont 5 mg

21 1MONTE-AIR 10 mg

22 1MONTE-AIR 4 mg

23 1MONTE-AIR 5 mg

24 1MONTE-AIR SPRINKLES

25 1Maclutek 10 mg

26 1Maclutek 4 mg Chewable Tablets

27 1Maclutek 5 mg Chewable Tablets

28 1Minair 10

29 1Minair 4

30 1Minair 5

31 1Montascend

32 1Monteflo 10

33 1Monteflo 4

34 1Monteflo 5

35 1Montelukast 4 LHC

36 1Montelukast 5 LHC

37 1Montelukast Biotech 10

38 1Montelukast Chew Biotech 4

39 1Montelukast Chew Biotech 5

40 1Montelukast Cipla 10

41 1Montelukast Cipla 4

42 1Montelukast Cipla 5

43 1Montelukast LHC 10

44 1Montelukast Oral Granules Unicorn

45 1Montelukast Specpharm 10

46 1Montelukast Specpharm 4

47 1Montelukast Specpharm 5

48 1Montelukast Unicorn 10

49 1Montelukast Unicorn 4

50 1Montelukast Unicorn 5

51 1SINTAIR 10 mg

52 1SINTAIR 4 mg

53 1SINTAIR 5 mg

54 1Singulair 10mg

55 1Singulair 4mg

56 1Singulair 5mg

57 1Singulair sprinkles

58 1Sintrine 10

59 1Sintrine 4

60 1Sintrine 5

61 1Sintrine Oral Granules

62 2Topraz 10

63 2Topraz 4

64 2Topraz 5

List of Suppliers

Product Main Page

01

Accord Healthcare (Pty) Ltd

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Accord Healthcare (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Montelukast Sodium

Brand Name : Astelair 10

Dosage Form : FCT

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Accord Healthcare (Pty) Ltd

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Accord Healthcare (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Montelukast Sodium

Brand Name : Astelair 4

Dosage Form : CHU

Dosage Strength : 4mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Accord Healthcare (Pty) Ltd

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Accord Healthcare (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Montelukast Sodium

Brand Name : Astelair 5

Dosage Form : CHU

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Adcock Ingram Limited

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Montelukast

Brand Name : Kulair 4

Dosage Form : CHU

Dosage Strength : 4mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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05

Adcock Ingram Limited

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Montelukast

Brand Name : Kulair 4

Dosage Form : CHU

Dosage Strength : 4mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Adcock Ingram Limited

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Montelukast

Brand Name : Kulair 5

Dosage Form : CHU

Dosage Strength : 5mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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07

Adcock Ingram Limited

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Montelukast

Brand Name : Kulair 5

Dosage Form : CHU

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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08

Adcock Ingram Limited

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Montelukast

Brand Name : Kulair 10

Dosage Form : FCT

Dosage Strength : 10mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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09

Adcock Ingram Limited

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Montelukast

Brand Name : Kulair 10

Dosage Form : FCT

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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10

Akacia Health Care (Pty) Ltd

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Akacia Health Care (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Montelukast

Brand Name : Minair 4

Dosage Form : TAB

Dosage Strength : 4mg

Packaging : 28X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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