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