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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 15 USDMF, 10 CEP/COS, 12 EU WC, 9 NDC API, 14 Listed Suppliers, $ API Reference Price

29 API Suppliers
15 USDMF
10 CEP/COS
12 EU WC
9 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

FINISHED DOSAGE FORMULATIONS

37 FDF Dossiers, 12 FDA Orange Book, 7 Europe, 13 Canada, 5 Listed Dossiers

37 FDF Dossiers
12 FDA Orange Book
7 Europe
13 Canada
5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 10MG BASE/PACKET, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET

drugProductComposition
TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE
FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 10MG BASE/PACKET
FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET

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relatedExcipients
1 Minakem
3 Evonik
4 Rochem International Inc
14 SPI Pharma
2 Seqens
14 DKSH
1 Pharm-RX Chemical
4 Faran Shimi Pharmaceutical
4 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
7 Gangwal Healthcare
4 Nanjing Well Pharmaceutical
2 Pfanstiehl
4 ACG Worldwide
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1 Aeon Procare
3 Alcedo Pharmachem
6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
25 BASF
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1 Shijiazhuang Huaxu Pharmaceutical
9 Sigachi Industries
2 The Dow Chemical Company
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1 Vertellus

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69 Coating Systems & Additives, 55 Fillers, Diluents & Binders, 40 Controlled & Modified Release, 37 Thickeners and Stabilizers, 34 Direct Compression, 25 Solubilizers, 24 Taste Masking, 22 Lubricants & Glidants, 20 Disintegrants & Superdisintegrants, 19 Granulation, 18 Topical, 16 Chewable & Orodispersible Aids, 16 Parenteral, 15 Film Formers & Plasticizers, 15 Co-Processed Excipients, 9 Emulsifying Agents, 9 Empty Capsules, 8 Rheology Modifiers, 7 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

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1 DATA COMPILATION #PharmaFlow
10 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 Finished Drug Prices

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1 Finished Drug Prices

MARKET PLACE

2 APIs, 1 FDF Dossiers

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2 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

7 US Patents, 2 US Exclusivities, 38 Health Canada Patents

patents
7 US Patents
2 US Exclusivities
38 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM , 1 USP , 1 Others

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4 EDQM
1 USP
1 Others

ANALYTICAL

1 BioAnalytical Methods

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1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 229

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

12DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

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Annual Reports (USD Million)

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273 RELATED EXCIPIENT COMPANIES

472EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Omeprazole magnesium, 95382-33-5, Magnesium;6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1h-benzimidazole

Molecular Formula

C₃₄H₃₈MgN₆O₆S₂+₂

Molecular Weight

715.1 g/mol

InChI Key

ZAUIQBMEUIXDRJ-UHFFFAOYSA-N

A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.

1 2D Structure

Omeprazole Magnesium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

magnesium;6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazole

2.1.2 InChI

InChI=1S/2C17H19N3O3S.Mg/c2*1-10-8-18-15(11(2)16(10)23-4)9-24(21)17-19-13-6-5-12(22-3)7-14(13)20-17;/h2*5-8H,9H2,1-4H3,(H,19,20);/q;;+2

2.1.3 InChI Key

ZAUIQBMEUIXDRJ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=CN=C(C(=C1OC)C)CS(=O)C2=NC3=C(N2)C=C(C=C3)OC.CC1=CN=C(C(=C1OC)C)CS(=O)C2=NC3=C(N2)C=C(C=C3)OC.[Mg+2]

2.2 Synonyms

2.2.1 MeSH Synonyms

1. H 168 68

2. H 168-68

3. H 16868

4. Magnesium, Omeprazole

5. Omeprazole

6. Omeprazole Magnesium

7. Omeprazole Sodium

8. Prilosec

9. Sodium, Omeprazole

2.2.2 Depositor-Supplied Synonyms

1. Omeprazole Magnesium

2. 95382-33-5

3. Magnesium;6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1h-benzimidazole

2.3 Create Date

2005-08-09

3 Chemical and Physical Properties

Molecular Formula	C₃₄H₃₈MgN₆O₆S₂+₂
Molecular Weight	715.1 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	12
Rotatable Bond Count	10
Exact Mass	714.2144670 g/mol
Monoisotopic Mass	714.2144670 g/mol
Topological Polar Surface Area	193 Å²
Heavy Atom Count	49
Formal Charge	2
Complexity	453
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	2
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Omeprazole magnesium
Drug Label	11 DESCRIPTIONThe active ingredient in PRILOSEC (omeprazole) Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secret...
Active Ingredient	Omeprazole magnesium
Dosage Form	Capsule, delayed release
Route	Oral
Strength	eq 20mg base
Market Status	Over the Counter
Company	Dr Reddys Labs

2 of 2
Drug Name	Omeprazole magnesium
Drug Label	11 DESCRIPTIONThe active ingredient in PRILOSEC (omeprazole) Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secret...
Active Ingredient	Omeprazole magnesium
Dosage Form	Capsule, delayed release
Route	Oral
Strength	eq 20mg base
Market Status	Over the Counter
Company	Dr Reddys Labs

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Proton Pump Inhibitors

Compounds that inhibit H(+)-K(+)-EXCHANGING ATPASE. They are used as ANTI-ULCER AGENTS and sometimes in place of HISTAMINE H2 ANTAGONISTS for GASTROESOPHAGEAL REFLUX. (See all compounds classified as Proton Pump Inhibitors.)

Anti-Ulcer Agents

Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]; Cytochrome P450 2C19 Inhibitors [MoA]

API SUPPLIERS

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE

USFDA APPLICATION NUMBER - 21229

DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 10MG BASE/PACKET

USFDA APPLICATION NUMBER - 22056

DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET

USFDA APPLICATION NUMBER - 22056

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ABOUT THIS PAGE

Omeprazole Magnesium Manufacturers

A Omeprazole Magnesium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omeprazole Magnesium, including repackagers and relabelers. The FDA regulates Omeprazole Magnesium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omeprazole Magnesium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Omeprazole Magnesium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Omeprazole Magnesium Suppliers

A Omeprazole Magnesium supplier is an individual or a company that provides Omeprazole Magnesium active pharmaceutical ingredient (API) or Omeprazole Magnesium finished formulations upon request. The Omeprazole Magnesium suppliers may include Omeprazole Magnesium API manufacturers, exporters, distributors and traders.

click here to find a list of Omeprazole Magnesium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Omeprazole Magnesium USDMF

A Omeprazole Magnesium DMF (Drug Master File) is a document detailing the whole manufacturing process of Omeprazole Magnesium active pharmaceutical ingredient (API) in detail. Different forms of Omeprazole Magnesium DMFs exist exist since differing nations have different regulations, such as Omeprazole Magnesium USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Omeprazole Magnesium DMF submitted to regulatory agencies in the US is known as a USDMF. Omeprazole Magnesium USDMF includes data on Omeprazole Magnesium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Omeprazole Magnesium USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Omeprazole Magnesium suppliers with USDMF on PharmaCompass.

Omeprazole Magnesium CEP

A Omeprazole Magnesium CEP of the European Pharmacopoeia monograph is often referred to as a Omeprazole Magnesium Certificate of Suitability (COS). The purpose of a Omeprazole Magnesium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Omeprazole Magnesium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Omeprazole Magnesium to their clients by showing that a Omeprazole Magnesium CEP has been issued for it. The manufacturer submits a Omeprazole Magnesium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Omeprazole Magnesium CEP holder for the record. Additionally, the data presented in the Omeprazole Magnesium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Omeprazole Magnesium DMF.

A Omeprazole Magnesium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Omeprazole Magnesium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Omeprazole Magnesium suppliers with CEP (COS) on PharmaCompass.

Omeprazole Magnesium WC

A Omeprazole Magnesium written confirmation (Omeprazole Magnesium WC) is an official document issued by a regulatory agency to a Omeprazole Magnesium manufacturer, verifying that the manufacturing facility of a Omeprazole Magnesium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Omeprazole Magnesium APIs or Omeprazole Magnesium finished pharmaceutical products to another nation, regulatory agencies frequently require a Omeprazole Magnesium WC (written confirmation) as part of the regulatory process.

click here to find a list of Omeprazole Magnesium suppliers with Written Confirmation (WC) on PharmaCompass.

Omeprazole Magnesium NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Omeprazole Magnesium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Omeprazole Magnesium API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Omeprazole Magnesium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Omeprazole Magnesium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Omeprazole Magnesium NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Omeprazole Magnesium suppliers with NDC on PharmaCompass.

Omeprazole Magnesium GMP

Omeprazole Magnesium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Omeprazole Magnesium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Omeprazole Magnesium GMP manufacturer or Omeprazole Magnesium GMP API supplier for your needs.

Omeprazole Magnesium CoA

A Omeprazole Magnesium CoA (Certificate of Analysis) is a formal document that attests to Omeprazole Magnesium's compliance with Omeprazole Magnesium specifications and serves as a tool for batch-level quality control.

Omeprazole Magnesium CoA mostly includes findings from lab analyses of a specific batch. For each Omeprazole Magnesium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Omeprazole Magnesium may be tested according to a variety of international standards, such as European Pharmacopoeia (Omeprazole Magnesium EP), Omeprazole Magnesium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Omeprazole Magnesium USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers

15 USDMF

10 CEP/COS

12 EU WC

9 NDC API

14 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

FINISHED DOSAGE FORMULATIONS

37 FDF Dossiers

12 FDA Orange Book

7 Europe

13 Canada

5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE

FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 10MG BASE/PACKET

FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET

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