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DRUG PRODUCT COMPOSITIONS0
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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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NDC 
ASMF
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.
EU-WC
NDC
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.
ASMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
ASMF
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USDMF
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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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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 Toprol XL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Toprol XL, including repackagers and relabelers. The FDA regulates Toprol XL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Toprol XL 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 Toprol XL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Toprol XL supplier is an individual or a company that provides Toprol XL active pharmaceutical ingredient (API) or Toprol XL finished formulations upon request. The Toprol XL suppliers may include Toprol XL API manufacturers, exporters, distributors and traders.
click here to find a list of Toprol XL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Toprol XL DMF (Drug Master File) is a document detailing the whole manufacturing process of Toprol XL active pharmaceutical ingredient (API) in detail. Different forms of Toprol XL DMFs exist exist since differing nations have different regulations, such as Toprol XL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Toprol XL DMF submitted to regulatory agencies in the US is known as a USDMF. Toprol XL USDMF includes data on Toprol XL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Toprol XL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Toprol XL suppliers with USDMF on PharmaCompass.
A Toprol XL CEP of the European Pharmacopoeia monograph is often referred to as a Toprol XL Certificate of Suitability (COS). The purpose of a Toprol XL CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Toprol XL EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Toprol XL to their clients by showing that a Toprol XL CEP has been issued for it. The manufacturer submits a Toprol XL CEP (COS) as part of the market authorization procedure, and it takes on the role of a Toprol XL CEP holder for the record. Additionally, the data presented in the Toprol XL CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Toprol XL DMF.
A Toprol XL CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Toprol XL 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 Toprol XL suppliers with CEP (COS) on PharmaCompass.
A Toprol XL written confirmation (Toprol XL WC) is an official document issued by a regulatory agency to a Toprol XL manufacturer, verifying that the manufacturing facility of a Toprol XL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Toprol XL APIs or Toprol XL finished pharmaceutical products to another nation, regulatory agencies frequently require a Toprol XL WC (written confirmation) as part of the regulatory process.
click here to find a list of Toprol XL 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 Toprol XL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Toprol XL 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 Toprol XL 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 Toprol XL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Toprol XL NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Toprol XL suppliers with NDC on PharmaCompass.
Toprol XL 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 Toprol XL 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 Toprol XL GMP manufacturer or Toprol XL GMP API supplier for your needs.
A Toprol XL CoA (Certificate of Analysis) is a formal document that attests to Toprol XL's compliance with Toprol XL specifications and serves as a tool for batch-level quality control.
Toprol XL CoA mostly includes findings from lab analyses of a specific batch. For each Toprol XL 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.
Toprol XL may be tested according to a variety of international standards, such as European Pharmacopoeia (Toprol XL EP), Toprol XL JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Toprol XL USP).
