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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
KDMF
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Parand Darou is a knowledge-based company, focused on the production of Narcotic APIs.
Temad- We think of world-class quality.
Veranova: A CDMO that manages complexity with confidence.
NDC
KDMF
Aspen API. More than just an API™
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
NDC
Veranova: A CDMO that manages complexity with confidence.
CEP/COS
NDC
KDMF
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20787
Submission : 2007-08-23
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-16
Pay. Date : 2012-11-23
DMF Number : 25856
Submission : 2012-03-30
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : CEP 1997-118 - Rev 12
Status : Valid
Issue Date : 2024-03-01
Type : Chemical
Substance Number : 74
Veranova: A CDMO that manages complexity with confidence.
Certificate Number : R1-CEP 1999-053 - Rev 03
Status : Valid
Issue Date : 2014-12-19
Type : Chemical
Substance Number : 74
Veranova: A CDMO that manages complexity with confidence.
Certificate Number : R1-CEP 2016-295 - Rev 00
Status : Valid
Issue Date : 2022-10-06
Type : Chemical
Substance Number : 74
Certificate Number : R1-CEP 2010-052 - Rev 01
Status : Valid
Issue Date : 2019-01-18
Type : Chemical
Substance Number : 74
Codeine Phosphate Hemihydrate, Process II
Certificate Number : CEP 2021-385 - Rev 01
Status : Valid
Issue Date : 2024-02-06
Type : Chemical
Substance Number : 74
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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DOSAGE - CAPSULE;ORAL - 325MG;50MG;40MG;30MG
USFDA APPLICATION NUMBER - 19429
DOSAGE - CAPSULE;ORAL - 325MG;50MG;40MG;30MG
USFDA APPLICATION NUMBER - 20232
DOSAGE - TABLET;ORAL - 300MG;15MG
USFDA APPLICATION NUMBER - 85055
DOSAGE - TABLET;ORAL - 300MG;30MG
USFDA APPLICATION NUMBER - 85055
DOSAGE - TABLET;ORAL - 300MG;60MG
USFDA APPLICATION NUMBER - 85055
DOSAGE - TABLET;ORAL - 300MG;60MG
USFDA APPLICATION NUMBER - 88629
DOSAGE - SYRUP;ORAL - 10MG/5ML;6.25MG/5ML
USFDA APPLICATION NUMBER - 88763
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ABOUT THIS PAGE
37
PharmaCompass offers a list of Codeine Phosphate 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 Codeine Phosphate manufacturer or Codeine Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Codeine Phosphate manufacturer or Codeine Phosphate supplier.
PharmaCompass also assists you with knowing the Codeine Phosphate API Price utilized in the formulation of products. Codeine Phosphate API Price is not always fixed or binding as the Codeine Phosphate Price is obtained through a variety of data sources. The Codeine Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Codeine Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Codeine Phosphate, including repackagers and relabelers. The FDA regulates Codeine Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Codeine Phosphate 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 Codeine Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Codeine Phosphate supplier is an individual or a company that provides Codeine Phosphate active pharmaceutical ingredient (API) or Codeine Phosphate finished formulations upon request. The Codeine Phosphate suppliers may include Codeine Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Codeine Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Codeine Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Codeine Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Codeine Phosphate DMFs exist exist since differing nations have different regulations, such as Codeine Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Codeine Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Codeine Phosphate USDMF includes data on Codeine Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Codeine Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Codeine Phosphate suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Codeine Phosphate Drug Master File in Japan (Codeine Phosphate JDMF) empowers Codeine Phosphate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Codeine Phosphate JDMF during the approval evaluation for pharmaceutical products. At the time of Codeine Phosphate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Codeine Phosphate suppliers with JDMF 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 Codeine Phosphate Drug Master File in Korea (Codeine Phosphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Codeine Phosphate. The MFDS reviews the Codeine Phosphate KDMF as part of the drug registration process and uses the information provided in the Codeine Phosphate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Codeine Phosphate 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 Codeine Phosphate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Codeine Phosphate suppliers with KDMF on PharmaCompass.
A Codeine Phosphate CEP of the European Pharmacopoeia monograph is often referred to as a Codeine Phosphate Certificate of Suitability (COS). The purpose of a Codeine Phosphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Codeine Phosphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Codeine Phosphate to their clients by showing that a Codeine Phosphate CEP has been issued for it. The manufacturer submits a Codeine Phosphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Codeine Phosphate CEP holder for the record. Additionally, the data presented in the Codeine Phosphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Codeine Phosphate DMF.
A Codeine Phosphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Codeine Phosphate 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 Codeine Phosphate suppliers with CEP (COS) on PharmaCompass.
A Codeine Phosphate written confirmation (Codeine Phosphate WC) is an official document issued by a regulatory agency to a Codeine Phosphate manufacturer, verifying that the manufacturing facility of a Codeine Phosphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Codeine Phosphate APIs or Codeine Phosphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Codeine Phosphate WC (written confirmation) as part of the regulatory process.
click here to find a list of Codeine Phosphate 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 Codeine Phosphate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Codeine Phosphate 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 Codeine Phosphate 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 Codeine Phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Codeine Phosphate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Codeine Phosphate suppliers with NDC on PharmaCompass.
Codeine Phosphate 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 Codeine Phosphate 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 Codeine Phosphate GMP manufacturer or Codeine Phosphate GMP API supplier for your needs.
A Codeine Phosphate CoA (Certificate of Analysis) is a formal document that attests to Codeine Phosphate's compliance with Codeine Phosphate specifications and serves as a tool for batch-level quality control.
Codeine Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Codeine Phosphate 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.
Codeine Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Codeine Phosphate EP), Codeine Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Codeine Phosphate USP).
