Synopsis
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JDMF
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KDMF
0
VMF
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Australia
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Jai Radhe Sales is your partner for all your sourcing needs.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
NDC 
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Harika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
NDC
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USDMF
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-03
Pay. Date : 2024-06-14
DMF Number : 38487
Submission : 2023-12-26
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-31
Pay. Date : 2022-12-28
DMF Number : 37476
Submission : 2022-12-17
Status :
Type : II
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Doxylamine 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 Doxylamine Succinate manufacturer or Doxylamine Succinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Doxylamine Succinate manufacturer or Doxylamine Succinate supplier.
PharmaCompass also assists you with knowing the Doxylamine Succinate API Price utilized in the formulation of products. Doxylamine Succinate API Price is not always fixed or binding as the Doxylamine Succinate Price is obtained through a variety of data sources. The Doxylamine Succinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sedaplus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sedaplus, including repackagers and relabelers. The FDA regulates Sedaplus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sedaplus 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 Sedaplus manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sedaplus supplier is an individual or a company that provides Sedaplus active pharmaceutical ingredient (API) or Sedaplus finished formulations upon request. The Sedaplus suppliers may include Sedaplus API manufacturers, exporters, distributors and traders.
click here to find a list of Sedaplus suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sedaplus DMF (Drug Master File) is a document detailing the whole manufacturing process of Sedaplus active pharmaceutical ingredient (API) in detail. Different forms of Sedaplus DMFs exist exist since differing nations have different regulations, such as Sedaplus USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sedaplus DMF submitted to regulatory agencies in the US is known as a USDMF. Sedaplus USDMF includes data on Sedaplus's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sedaplus USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sedaplus suppliers with USDMF on PharmaCompass.
A Sedaplus CEP of the European Pharmacopoeia monograph is often referred to as a Sedaplus Certificate of Suitability (COS). The purpose of a Sedaplus CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sedaplus EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sedaplus to their clients by showing that a Sedaplus CEP has been issued for it. The manufacturer submits a Sedaplus CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sedaplus CEP holder for the record. Additionally, the data presented in the Sedaplus CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sedaplus DMF.
A Sedaplus CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sedaplus 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 Sedaplus suppliers with CEP (COS) on PharmaCompass.
A Sedaplus written confirmation (Sedaplus WC) is an official document issued by a regulatory agency to a Sedaplus manufacturer, verifying that the manufacturing facility of a Sedaplus active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sedaplus APIs or Sedaplus finished pharmaceutical products to another nation, regulatory agencies frequently require a Sedaplus WC (written confirmation) as part of the regulatory process.
click here to find a list of Sedaplus 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 Sedaplus as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sedaplus 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 Sedaplus 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 Sedaplus and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sedaplus NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sedaplus suppliers with NDC on PharmaCompass.
Sedaplus 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 Sedaplus 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 Sedaplus GMP manufacturer or Sedaplus GMP API supplier for your needs.
A Sedaplus CoA (Certificate of Analysis) is a formal document that attests to Sedaplus's compliance with Sedaplus specifications and serves as a tool for batch-level quality control.
Sedaplus CoA mostly includes findings from lab analyses of a specific batch. For each Sedaplus 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.
Sedaplus may be tested according to a variety of international standards, such as European Pharmacopoeia (Sedaplus EP), Sedaplus JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sedaplus USP).
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