Synopsis
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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Jai Radhe Sales is your partner for all your sourcing needs.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
CEP/COS 
KDMF
ASMF
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USDMF
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36375
Submission : 2021-12-28
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35577
Submission : 2021-03-29
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-03-27
Pay. Date : 2020-03-23
DMF Number : 24813
Submission : 2011-03-31
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-07
Pay. Date : 2019-02-01
DMF Number : 17103
Submission : 2004-01-20
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-22
Pay. Date : 2019-03-11
DMF Number : 18779
Submission : 2005-09-15
Status :
Type : II
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15886
Submission : 2002-02-28
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-04
Pay. Date : 2023-04-18
DMF Number : 36849
Submission : 2022-05-19
Status :
Type : II
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36393
Submission : 2021-10-18
Status :
Type : II
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-31
Pay. Date : 2020-12-07
DMF Number : 35357
Submission : 2020-12-07
Status :
Type : II
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Maalox Reflusso
Dosage Form : Gastro-Resistant Tablet
Dosage Strength : 20MG
Packaging :
Approval Date : 2012-07-10
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Maalox Reflusso
Dosage Form : Gastro-Resistant Tablet
Dosage Strength : 20MG
Packaging :
Approval Date : 2019-11-20
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Regulatory Info : Prescription
Registration Country : Denmark
Pantoprazole Sodium Sesquihydrate
Brand Name : Pantoprazole \"Orion\"
Dosage Form : Enteric-Coated Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 20-02-2018
Application Number : 28105861616
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Pantoprazole Sodium Sesquihydrate
Brand Name : Pantoprazole \"Orion\"
Dosage Form : Enteric-Coated Tablet
Dosage Strength : 40mg
Packaging :
Approval Date : 20-02-2018
Application Number : 28105861716
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Approved
Registration Country : Sweden
Pantoprazole Sodium Sesquihydrate
Brand Name : Pantoprazole Orion
Dosage Form : Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 24-01-2018
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Pantoprazole Sodium Sesquihydrate
Brand Name : Pantoprazole Orion
Dosage Form : Tablet
Dosage Strength : 40mg
Packaging :
Approval Date : 24-01-2018
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Enteric Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Enteric Coated Tablet
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info : Deregistered
Registration Country : Sweden
Pantoprazole Sodium Sesquihydrate
Brand Name : Pantoprazole Martindale Pharma
Dosage Form : Powder For Solution For Injection
Dosage Strength : 40mg
Packaging :
Approval Date : 03-09-2010
Application Number : 2.01E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info :
Registration Country : Italy
Brand Name : PANTOPRAZOLE THINK
Dosage Form : Gastroresistant Tablets
Dosage Strength : 20 mg
Packaging : 14 UNITS 20 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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DOSAGE - POWDER;INTRAVENOUS - EQ 40MG BASE/VI...DOSAGE - POWDER;INTRAVENOUS - EQ 40MG BASE/VIAL
USFDA APPLICATION NUMBER - 209463
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 20987
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 40...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 40MG BASE
USFDA APPLICATION NUMBER - 20987
DOSAGE - INJECTABLE;INTRAVENOUS - EQ 40MG BAS...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 40MG BASE/VIAL
USFDA APPLICATION NUMBER - 20988
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ANALYTICAL
ABOUT THIS PAGE
34
PharmaCompass offers a list of Pantoprazole Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pantoprazole Sodium manufacturer or Pantoprazole Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pantoprazole Sodium manufacturer or Pantoprazole Sodium supplier.
A Peptazol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Peptazol, including repackagers and relabelers. The FDA regulates Peptazol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Peptazol 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 Peptazol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Peptazol supplier is an individual or a company that provides Peptazol active pharmaceutical ingredient (API) or Peptazol finished formulations upon request. The Peptazol suppliers may include Peptazol API manufacturers, exporters, distributors and traders.
click here to find a list of Peptazol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Peptazol DMF (Drug Master File) is a document detailing the whole manufacturing process of Peptazol active pharmaceutical ingredient (API) in detail. Different forms of Peptazol DMFs exist exist since differing nations have different regulations, such as Peptazol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Peptazol DMF submitted to regulatory agencies in the US is known as a USDMF. Peptazol USDMF includes data on Peptazol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Peptazol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Peptazol suppliers with USDMF 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 Peptazol Drug Master File in Korea (Peptazol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Peptazol. The MFDS reviews the Peptazol KDMF as part of the drug registration process and uses the information provided in the Peptazol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Peptazol 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 Peptazol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Peptazol suppliers with KDMF on PharmaCompass.
A Peptazol CEP of the European Pharmacopoeia monograph is often referred to as a Peptazol Certificate of Suitability (COS). The purpose of a Peptazol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Peptazol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Peptazol to their clients by showing that a Peptazol CEP has been issued for it. The manufacturer submits a Peptazol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Peptazol CEP holder for the record. Additionally, the data presented in the Peptazol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Peptazol DMF.
A Peptazol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Peptazol 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 Peptazol suppliers with CEP (COS) on PharmaCompass.
A Peptazol written confirmation (Peptazol WC) is an official document issued by a regulatory agency to a Peptazol manufacturer, verifying that the manufacturing facility of a Peptazol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Peptazol APIs or Peptazol finished pharmaceutical products to another nation, regulatory agencies frequently require a Peptazol WC (written confirmation) as part of the regulatory process.
click here to find a list of Peptazol 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 Peptazol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Peptazol 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 Peptazol 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 Peptazol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Peptazol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Peptazol suppliers with NDC on PharmaCompass.
Peptazol 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 Peptazol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Peptazol GMP manufacturer or Peptazol GMP API supplier for your needs.
A Peptazol CoA (Certificate of Analysis) is a formal document that attests to Peptazol's compliance with Peptazol specifications and serves as a tool for batch-level quality control.
Peptazol CoA mostly includes findings from lab analyses of a specific batch. For each Peptazol 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.
Peptazol may be tested according to a variety of international standards, such as European Pharmacopoeia (Peptazol EP), Peptazol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Peptazol USP).
