Synopsis
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19810
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19810
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19810
DOSAGE - TABLET, DELAYED RELEASE;ORAL - 325MG...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 325MG;40MG
USFDA APPLICATION NUMBER - 205103
DOSAGE - TABLET, DELAYED RELEASE;ORAL - 81MG;...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 81MG;40MG
USFDA APPLICATION NUMBER - 205103
DOSAGE - TABLET, ORALLY DISINTEGRATING, DELAY...DOSAGE - TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL - 20MG
USFDA APPLICATION NUMBER - 209400
DOSAGE - CAPSULE;ORAL - 20MG;1.1GM
USFDA APPLICATION NUMBER - 21849
DOSAGE - CAPSULE;ORAL - 40MG;1.1GM
USFDA APPLICATION NUMBER - 21849
DOSAGE - TABLET, DELAYED RELEASE;ORAL - 20MG
USFDA APPLICATION NUMBER - 22032
DOSAGE - CAPSULE;ORAL - 20MG;1.1GM
USFDA APPLICATION NUMBER - 22281
DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED RE...DOSAGE - 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**
USFDA APPLICATION NUMBER - 50824
Related Excipient Companies
Minakem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Doshion Polyscience
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Symrise
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vertellus
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Controlled & Modified Release
Thickeners and Stabilizers
Disintegrants & Superdisintegrants
Solubilizers
Direct Compression
Granulation
Taste Masking
Topical
Lubricants & Glidants
Film Formers & Plasticizers
Chewable & Orodispersible Aids
Parenteral
Co-Processed Excipients
Rheology Modifiers
Emulsifying Agents
Empty Capsules
API Stability Enhancers
Coloring Agents
Vegetarian Capsules
Surfactant & Foaming Agents
Soft Gelatin
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
BioAnalytical Methods
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Analytical Methods
ABOUT THIS PAGE
14
PharmaCompass offers a list of Omeprazole API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Omeprazole manufacturer or Omeprazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Omeprazole manufacturer or Omeprazole supplier.
PharmaCompass also assists you with knowing the Omeprazole API Price utilized in the formulation of products. Omeprazole API Price is not always fixed or binding as the Omeprazole Price is obtained through a variety of data sources. The Omeprazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mopral manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mopral, including repackagers and relabelers. The FDA regulates Mopral manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mopral 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 Mopral manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mopral supplier is an individual or a company that provides Mopral active pharmaceutical ingredient (API) or Mopral finished formulations upon request. The Mopral suppliers may include Mopral API manufacturers, exporters, distributors and traders.
click here to find a list of Mopral suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mopral DMF (Drug Master File) is a document detailing the whole manufacturing process of Mopral active pharmaceutical ingredient (API) in detail. Different forms of Mopral DMFs exist exist since differing nations have different regulations, such as Mopral USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mopral DMF submitted to regulatory agencies in the US is known as a USDMF. Mopral USDMF includes data on Mopral's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mopral USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mopral suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Mopral Drug Master File in Japan (Mopral JDMF) empowers Mopral API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Mopral JDMF during the approval evaluation for pharmaceutical products. At the time of Mopral JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Mopral suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Mopral Drug Master File in Korea (Mopral KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mopral. The MFDS reviews the Mopral KDMF as part of the drug registration process and uses the information provided in the Mopral KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mopral KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Mopral API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mopral suppliers with KDMF on PharmaCompass.
A Mopral CEP of the European Pharmacopoeia monograph is often referred to as a Mopral Certificate of Suitability (COS). The purpose of a Mopral CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mopral EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mopral to their clients by showing that a Mopral CEP has been issued for it. The manufacturer submits a Mopral CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mopral CEP holder for the record. Additionally, the data presented in the Mopral CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mopral DMF.
A Mopral CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mopral 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 Mopral suppliers with CEP (COS) on PharmaCompass.
A Mopral written confirmation (Mopral WC) is an official document issued by a regulatory agency to a Mopral manufacturer, verifying that the manufacturing facility of a Mopral active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mopral APIs or Mopral finished pharmaceutical products to another nation, regulatory agencies frequently require a Mopral WC (written confirmation) as part of the regulatory process.
click here to find a list of Mopral suppliers with Written Confirmation (WC) on PharmaCompass.
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 Mopral as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mopral API and other APIs are published in this directory by the FDA.
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 Mopral 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.
The NDC directory also contains data on finished compounded human drug products that contain Mopral and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mopral NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mopral suppliers with NDC on PharmaCompass.
Mopral 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 Mopral 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 Mopral GMP manufacturer or Mopral GMP API supplier for your needs.
A Mopral CoA (Certificate of Analysis) is a formal document that attests to Mopral's compliance with Mopral specifications and serves as a tool for batch-level quality control.
Mopral CoA mostly includes findings from lab analyses of a specific batch. For each Mopral 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.
Mopral may be tested according to a variety of international standards, such as European Pharmacopoeia (Mopral EP), Mopral JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mopral USP).
