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PharmaCompass offers a list of Betahistine Dihydrochloride 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 Betahistine Dihydrochloride manufacturer or Betahistine Dihydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Betahistine Dihydrochloride manufacturer or Betahistine Dihydrochloride supplier.
PharmaCompass also assists you with knowing the Betahistine Dihydrochloride API Price utilized in the formulation of products. Betahistine Dihydrochloride API Price is not always fixed or binding as the Betahistine Dihydrochloride Price is obtained through a variety of data sources. The Betahistine Dihydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Serc manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Serc, including repackagers and relabelers. The FDA regulates Serc manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Serc 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 Serc manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Serc supplier is an individual or a company that provides Serc active pharmaceutical ingredient (API) or Serc finished formulations upon request. The Serc suppliers may include Serc API manufacturers, exporters, distributors and traders.
click here to find a list of Serc suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Serc DMF (Drug Master File) is a document detailing the whole manufacturing process of Serc active pharmaceutical ingredient (API) in detail. Different forms of Serc DMFs exist exist since differing nations have different regulations, such as Serc USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Serc DMF submitted to regulatory agencies in the US is known as a USDMF. Serc USDMF includes data on Serc's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Serc USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Serc 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 Serc Drug Master File in Korea (Serc KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Serc. The MFDS reviews the Serc KDMF as part of the drug registration process and uses the information provided in the Serc KDMF to evaluate the safety and efficacy of the drug.
After submitting a Serc 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 Serc API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Serc suppliers with KDMF on PharmaCompass.
A Serc CEP of the European Pharmacopoeia monograph is often referred to as a Serc Certificate of Suitability (COS). The purpose of a Serc CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Serc EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Serc to their clients by showing that a Serc CEP has been issued for it. The manufacturer submits a Serc CEP (COS) as part of the market authorization procedure, and it takes on the role of a Serc CEP holder for the record. Additionally, the data presented in the Serc CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Serc DMF.
A Serc CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Serc 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 Serc suppliers with CEP (COS) on PharmaCompass.
A Serc written confirmation (Serc WC) is an official document issued by a regulatory agency to a Serc manufacturer, verifying that the manufacturing facility of a Serc active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Serc APIs or Serc finished pharmaceutical products to another nation, regulatory agencies frequently require a Serc WC (written confirmation) as part of the regulatory process.
click here to find a list of Serc 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 Serc as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Serc 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 Serc 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 Serc and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Serc NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Serc suppliers with NDC on PharmaCompass.
Serc 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 Serc 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 Serc GMP manufacturer or Serc GMP API supplier for your needs.
A Serc CoA (Certificate of Analysis) is a formal document that attests to Serc's compliance with Serc specifications and serves as a tool for batch-level quality control.
Serc CoA mostly includes findings from lab analyses of a specific batch. For each Serc 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.
Serc may be tested according to a variety of international standards, such as European Pharmacopoeia (Serc EP), Serc JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Serc USP).
