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