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API SUPPLIERS
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USDMF
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LEBSA- Your strategic API source for niche molecules.
About the Company : Lebsa is an innovative European lab specializing in niche API synthesis, manufacture, and commercialization. With 70 years of experience, it is a reputable global player in generic...
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
BioXera Pharma: A trusted partner for high-quality human and veterinary APIs and intermediates across global regulated markets.
About the Company : BioXera Pharma is a quality-focused manufacturer of APIs, veterinary APIs, and intermediates, with expertise in innovative process development for domestic and regulated internatio...
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
About the Company : Synnat Pharma is a fast-growing pharmaceutical company focused on the development, identification, production, and distribution of phytochemicals and botanical extracts. Its APIs a...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Hebei AiYoung Pharmaceutical Technology delivering high-quality APIs, intermediates, and end-to-end pharma solutions globally.
About the Company : Hebei AiYoung Pharmaceutical Group is an integrated pharmaceutical company engaged in the production, research, and sale of chemical medicines, APIs, intermediates, and finished fo...
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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, 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.
A Fidium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fidium, including repackagers and relabelers. The FDA regulates Fidium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fidium 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 Fidium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Fidium supplier is an individual or a company that provides Fidium active pharmaceutical ingredient (API) or Fidium finished formulations upon request. The Fidium suppliers may include Fidium API manufacturers, exporters, distributors and traders.
click here to find a list of Fidium suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Fidium DMF (Drug Master File) is a document detailing the whole manufacturing process of Fidium active pharmaceutical ingredient (API) in detail. Different forms of Fidium DMFs exist exist since differing nations have different regulations, such as Fidium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fidium DMF submitted to regulatory agencies in the US is known as a USDMF. Fidium USDMF includes data on Fidium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fidium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fidium 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 Fidium Drug Master File in Korea (Fidium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fidium. The MFDS reviews the Fidium KDMF as part of the drug registration process and uses the information provided in the Fidium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fidium 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 Fidium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fidium suppliers with KDMF on PharmaCompass.
A Fidium CEP of the European Pharmacopoeia monograph is often referred to as a Fidium Certificate of Suitability (COS). The purpose of a Fidium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fidium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fidium to their clients by showing that a Fidium CEP has been issued for it. The manufacturer submits a Fidium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fidium CEP holder for the record. Additionally, the data presented in the Fidium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fidium DMF.
A Fidium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fidium 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 Fidium suppliers with CEP (COS) on PharmaCompass.
A Fidium written confirmation (Fidium WC) is an official document issued by a regulatory agency to a Fidium manufacturer, verifying that the manufacturing facility of a Fidium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fidium APIs or Fidium finished pharmaceutical products to another nation, regulatory agencies frequently require a Fidium WC (written confirmation) as part of the regulatory process.
click here to find a list of Fidium 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 Fidium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fidium 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 Fidium 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 Fidium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fidium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fidium suppliers with NDC on PharmaCompass.
Fidium 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 Fidium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Fidium GMP manufacturer or Fidium GMP API supplier for your needs.
A Fidium CoA (Certificate of Analysis) is a formal document that attests to Fidium's compliance with Fidium specifications and serves as a tool for batch-level quality control.
Fidium CoA mostly includes findings from lab analyses of a specific batch. For each Fidium 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.
Fidium may be tested according to a variety of international standards, such as European Pharmacopoeia (Fidium EP), Fidium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fidium USP).
