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Veranova: A CDMO that manages complexity with confidence.
KDMF
ROW, CN 
Veranova: A CDMO that manages complexity with confidence.
ROW, CN
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Veranova: A CDMO that manages complexity with confidence.
Dihydrocodeine Hydrogen Tartrate
Certificate Number : R1-CEP 2003-209 - Rev 01
Status : Valid
Issue Date : 2015-02-13
Type : Chemical
Substance Number : 1776
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Veranova: A CDMO that manages complexity with confidence.
Registrant Name : Baeksu Pharmaceutical Co., Ltd.
Registration Date : 2021-03-10
Registration Number : 20210310-209-J-865(A)
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Veranova: A CDMO that manages complexity with confidence.
Registrant Name : Samung Industrial Co., Ltd.
Registration Date : 2021-03-10
Registration Number : 20210310-209-J-865
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
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INTERMEDIATE SUPPLIERS
Temad- We think of world-class quality.
CAS Number : 3861-72-1
End Use API : Dihydrocodeine Tartrate
About The Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class...
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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 Paracodin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Paracodin, including repackagers and relabelers. The FDA regulates Paracodin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Paracodin 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 Paracodin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Paracodin supplier is an individual or a company that provides Paracodin active pharmaceutical ingredient (API) or Paracodin finished formulations upon request. The Paracodin suppliers may include Paracodin API manufacturers, exporters, distributors and traders.
click here to find a list of Paracodin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Paracodin DMF (Drug Master File) is a document detailing the whole manufacturing process of Paracodin active pharmaceutical ingredient (API) in detail. Different forms of Paracodin DMFs exist exist since differing nations have different regulations, such as Paracodin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Paracodin DMF submitted to regulatory agencies in the US is known as a USDMF. Paracodin USDMF includes data on Paracodin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Paracodin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Paracodin 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 Paracodin Drug Master File in Korea (Paracodin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Paracodin. The MFDS reviews the Paracodin KDMF as part of the drug registration process and uses the information provided in the Paracodin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Paracodin 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 Paracodin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Paracodin suppliers with KDMF on PharmaCompass.
A Paracodin CEP of the European Pharmacopoeia monograph is often referred to as a Paracodin Certificate of Suitability (COS). The purpose of a Paracodin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Paracodin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Paracodin to their clients by showing that a Paracodin CEP has been issued for it. The manufacturer submits a Paracodin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Paracodin CEP holder for the record. Additionally, the data presented in the Paracodin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Paracodin DMF.
A Paracodin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Paracodin 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 Paracodin 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 Paracodin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Paracodin 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 Paracodin 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 Paracodin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Paracodin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Paracodin suppliers with NDC on PharmaCompass.
Paracodin 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 Paracodin 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 Paracodin GMP manufacturer or Paracodin GMP API supplier for your needs.
A Paracodin CoA (Certificate of Analysis) is a formal document that attests to Paracodin's compliance with Paracodin specifications and serves as a tool for batch-level quality control.
Paracodin CoA mostly includes findings from lab analyses of a specific batch. For each Paracodin 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.
Paracodin may be tested according to a variety of international standards, such as European Pharmacopoeia (Paracodin EP), Paracodin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Paracodin USP).
