Omeprazole | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Omeprazole
South Africa

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

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Gonane Omeprazole

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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Omeprazole

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

109 API Suppliers, 42 USDMF, 38 CEP/COS, 9 JDMF, 25 EU WC, 25 KDMF, 33 NDC API, 2 VMF, 69 Listed Suppliers, $ API Reference Price

109 API Suppliers
42 USDMF
38 CEP/COS
9 JDMF
25 EU WC
25 KDMF
33 NDC API
2 VMF
69 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

24 Intermediates Suppliers

24 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

943 FDF Dossiers, 95 FDA Orange Book, 571 Europe, 11 Canada, 53 Australia, 40 South Africa, 173 Listed Dossiers

943 FDF Dossiers
95 FDA Orange Book
571 Europe
11 Canada
53 Australia
40 South Africa
173 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED REL PELLETS;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 325MG;40MG, TABLET, DELAYED RELEASE;ORAL - 81MG;40MG, TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL - 20MG, CAPSULE;ORAL - 20MG;1.1GM, CAPSULE;ORAL - 40MG;1.1GM, TABLET, DELAYED RELEASE;ORAL - 20MG, CAPSULE;ORAL - 20MG;1.1GM, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, DELAYED REL PELLETS;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, DELAYED REL PELLETS;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, DELAYED RELEASE;ORAL - 325MG;40MG
TABLET, DELAYED RELEASE;ORAL - 81MG;40MG
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL - 20MG
CAPSULE;ORAL - 20MG;1.1GM
CAPSULE;ORAL - 40MG;1.1GM
TABLET, DELAYED RELEASE;ORAL - 20MG
CAPSULE;ORAL - 20MG;1.1GM
CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 5 Rochem International Inc, 20 SPI Pharma, 2 Seqens, 13 DKSH, 2 Pharm-RX Chemical, 9 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 40 BASF, 1 Bioplus Life Sciences, 15 Corel Pharma Chem, 7 DFE Pharma, 3 Doshion Polyscience, 4 Finar, 13 Gangwal Chemicals, 14 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 38 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 9 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

100 Fillers, Diluents & Binders, 77 Coating Systems & Additives, 51 Direct Compression, 48 Controlled & Modified Release, 45 Thickeners and Stabilizers, 44 Disintegrants & Superdisintegrants, 38 Solubilizers, 36 Granulation, 30 Taste Masking, 29 Lubricants & Glidants, 27 Topical, 23 Co-Processed Excipients, 22 Chewable & Orodispersible Aids, 22 Parenteral, 22 Film Formers & Plasticizers, 10 Emulsifying Agents, 9 Rheology Modifiers, 9 Empty Capsules, 8 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

100 Fillers, Diluents & Binders
77 Coating Systems & Additives
51 Direct Compression
48 Controlled & Modified Release
45 Thickeners and Stabilizers
44 Disintegrants & Superdisintegrants
38 Solubilizers
36 Granulation
30 Taste Masking
29 Lubricants & Glidants
27 Topical
23 Co-Processed Excipients
22 Chewable & Orodispersible Aids
22 Parenteral
22 Film Formers & Plasticizers
10 Emulsifying Agents
9 Rheology Modifiers
9 Empty Capsules
8 API Stability Enhancers
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 83 NEWS #PharmaBuzz

4 DATA COMPILATION #PharmaFlow
83 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 523 Finished Drug Prices, 9 Annual Reports

3 US Medicaid Prescriptions
523 Finished Drug Prices
9 Annual Reports

MARKET PLACE

61 APIs, 71 FDF Dossiers, 1 EXCIPIENTS

61 APIs
71 FDF Dossiers
1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

14 US Patents, 23 Health Canada Patents

14 US Patents
23 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 5 USP, 50 Others

3 EDQM
5 USP
50 Others

ANALYTICAL

3 BioAnalytical Methods, 1 Analytical Methods

3 BioAnalytical Methods
1 Analytical Methods

$ API Ref.Price (USD/KG) : 65 Xls

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01 2Pharmacare Limited, Woodmead

02 1Accord Healthcare (Pty) Ltd

03 1Acino Pharma (Pty) Ltd

04 1Activo Health (Pty) Ltd

05 4Adcock Ingram Limited

06 4Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

07 2Austell Pharmaceuticals (Pty) Ltd

08 2Dezzo Trading 392 (Pty) Ltd

09 10Dr Reddy's Laboratories (Pty) Ltd

10 2Equity Pharmaceuticals (Pty) Ltd

11 1Safeline Pharmaceuticals (Pty) Ltd

12 6Sandoz SA (Pty) Ltd

13 4Teva Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

40 All

01 3OMEPRAZOLE

02 37Omeprazole

filter Dosage Form Reset all filters

40 All

01 30CAP

02 5INJ

03 5TAB

filter Brand Name Reset all filters

40 All

01 1Accord Omeprazole 40 mg Injection

02 1Adco Omeprazole 20

03 1Adco-Omeprazole 20

04 1Altosec 10

05 1Altosec 20

06 1Altosec 40 mg/10 ml

07 1Corpocid 20 mg

08 1DRL-Omeprazole 10

09 1DRL-Omeprazole 20

10 1DRL-Omeprazole 40

11 1LOKIT OD 20

12 1LOKIT OD 40

13 1LOKIT OTC

14 1Lokit

15 2Losec Inf 40mg

16 1Losec Mups 10

17 2Losec Mups 20

18 1Losec Mups 40

19 2Nozer Capsules

20 1OMIFLUX 20

21 1Omeprazole Safeline Injection 40 mg

22 1Omez 10

23 2Omez 20

24 3Omez 40

25 1Omez OTC 20

26 1Omiloc

27 3Probitor 20

28 1Rapacid

29 1Rapacid 20

30 1Sandoz Omeprazole 20

31 1Tumsigon

32 1Tumsigon OTC

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01

Pharmacare Limited, Woodmead

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Altosec 20

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Pharmacare Limited, Woodmead

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Altosec 40 mg/10 ml

Dosage Form : INJ

Dosage Strength : 40mg/10ml

Packaging : 10X1mg/10ml

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Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Accord Healthcare (Pty) Ltd

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Accord Healthcare (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Accord Omeprazole 40 mg Injection

Dosage Form : INJ

Dosage Strength : 40mg

Packaging : 1X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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Activo Health (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Corpocid 20 mg

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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Adcock Ingram Limited

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Adco Omeprazole 20

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 28X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Adco-Omeprazole 20

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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Adcock Ingram Limited

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Rapacid

Dosage Form : CAP

Dosage Strength : 10MG

Packaging : 14X1MG

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Regulatory Info : Generic

Registration Country : South Africa

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Rapacid 20

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 14X1mg

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Regulatory Info : Generic

Registration Country : South Africa

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Astrazeneca Pharmaceuticals (Pty) Ltd - ...

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Losec Mups 20

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 14X1mg

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Registration Country : South Africa

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Acino Pharma (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Altosec 10

Dosage Form : CAP

Dosage Strength : 10mg

Packaging : 28X1mg

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Regulatory Info : Generic

Registration Country : South Africa

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