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