Synopsis
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JDMF
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KDMF
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VMF
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Canada
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South Africa
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
CEP/COS
NDC
ASMF
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
EU-WC
NDC
ASMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
EU-WC
NDC
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
ASMF
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USDMF
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 : 2021-05-27
Pay. Date : 2021-04-19
DMF Number : 33544
Submission : 2019-03-27
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 35959
Submission : 2021-06-13
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-19
Pay. Date : 2024-02-28
DMF Number : 18348
Submission : 2005-05-13
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-12
Pay. Date : 2013-09-23
DMF Number : 16621
Submission : 2003-06-19
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-04
Pay. Date : 2013-06-19
DMF Number : 14612
Submission : 1999-12-09
Status :
Type : II
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Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Certificate Number : CEP 2004-202 - Rev 07
Status : Valid
Issue Date : 2024-02-27
Type : Chemical
Substance Number : 1448
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Metoprolol Succinate USP/ Ph.Eur
Date of Issue : 2022-05-02
Valid Till : 2025-05-01
Written Confirmation Number : WC-0526
Address of the Firm : Unit-V, Plot No.30, Jawaharlal Nehru Pharmacity, Parawada (M), Visakapatnam-531 ...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-07-28
Valid Till : 2025-12-30
Written Confirmation Number : WC-0390
Address of the Firm : Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District -532409, Andhr...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-07-28
Valid Till : 2025-12-30
Written Confirmation Number : WC-0390
Address of the Firm : Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District -532409, Andhr...
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
About the Company : Emay Pharmaceuticals Pvt Ltd functions as the merchant export division of M/s. Bhavna Laboratories Pvt Ltd. As a GMP-approved API manufacturing company, we boast over three decades...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 100MG TARTRATE
USFDA APPLICATION NUMBER - 19962
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 200MG TARTRATE
USFDA APPLICATION NUMBER - 19962
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 25MG TARTRATE
USFDA APPLICATION NUMBER - 19962
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 50MG TARTRATE
USFDA APPLICATION NUMBER - 19962
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 100MG TARTRATE
USFDA APPLICATION NUMBER - 210428
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 200MG TARTRATE
USFDA APPLICATION NUMBER - 210428
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 25MG TARTRATE
USFDA APPLICATION NUMBER - 210428
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 50MG TARTRATE
USFDA APPLICATION NUMBER - 210428
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21956
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21956
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21956
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ABOUT THIS PAGE
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PharmaCompass offers a list of Metoprolol Succinate 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 Metoprolol Succinate manufacturer or Metoprolol Succinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Metoprolol Succinate manufacturer or Metoprolol Succinate supplier.
PharmaCompass also assists you with knowing the Metoprolol Succinate API Price utilized in the formulation of products. Metoprolol Succinate API Price is not always fixed or binding as the Metoprolol Succinate Price is obtained through a variety of data sources. The Metoprolol Succinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Metoprolol Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Metoprolol Succinate, including repackagers and relabelers. The FDA regulates Metoprolol Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Metoprolol Succinate 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 Metoprolol Succinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Metoprolol Succinate supplier is an individual or a company that provides Metoprolol Succinate active pharmaceutical ingredient (API) or Metoprolol Succinate finished formulations upon request. The Metoprolol Succinate suppliers may include Metoprolol Succinate API manufacturers, exporters, distributors and traders.
click here to find a list of Metoprolol Succinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Metoprolol Succinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Metoprolol Succinate active pharmaceutical ingredient (API) in detail. Different forms of Metoprolol Succinate DMFs exist exist since differing nations have different regulations, such as Metoprolol Succinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Metoprolol Succinate DMF submitted to regulatory agencies in the US is known as a USDMF. Metoprolol Succinate USDMF includes data on Metoprolol Succinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Metoprolol Succinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Metoprolol Succinate suppliers with USDMF on PharmaCompass.
A Metoprolol Succinate CEP of the European Pharmacopoeia monograph is often referred to as a Metoprolol Succinate Certificate of Suitability (COS). The purpose of a Metoprolol Succinate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Metoprolol Succinate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Metoprolol Succinate to their clients by showing that a Metoprolol Succinate CEP has been issued for it. The manufacturer submits a Metoprolol Succinate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Metoprolol Succinate CEP holder for the record. Additionally, the data presented in the Metoprolol Succinate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Metoprolol Succinate DMF.
A Metoprolol Succinate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Metoprolol Succinate 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 Metoprolol Succinate suppliers with CEP (COS) on PharmaCompass.
A Metoprolol Succinate written confirmation (Metoprolol Succinate WC) is an official document issued by a regulatory agency to a Metoprolol Succinate manufacturer, verifying that the manufacturing facility of a Metoprolol Succinate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Metoprolol Succinate APIs or Metoprolol Succinate finished pharmaceutical products to another nation, regulatory agencies frequently require a Metoprolol Succinate WC (written confirmation) as part of the regulatory process.
click here to find a list of Metoprolol Succinate 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 Metoprolol Succinate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Metoprolol Succinate 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 Metoprolol Succinate 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 Metoprolol Succinate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Metoprolol Succinate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Metoprolol Succinate suppliers with NDC on PharmaCompass.
Metoprolol Succinate 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 Metoprolol Succinate 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 Metoprolol Succinate GMP manufacturer or Metoprolol Succinate GMP API supplier for your needs.
A Metoprolol Succinate CoA (Certificate of Analysis) is a formal document that attests to Metoprolol Succinate's compliance with Metoprolol Succinate specifications and serves as a tool for batch-level quality control.
Metoprolol Succinate CoA mostly includes findings from lab analyses of a specific batch. For each Metoprolol Succinate 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.
Metoprolol Succinate may be tested according to a variety of international standards, such as European Pharmacopoeia (Metoprolol Succinate EP), Metoprolol Succinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Metoprolol Succinate USP).
