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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.
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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USDMF
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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 2016-295 - Rev 00
Status : Valid
Issue Date : 2022-10-06
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
Codeine Phosphate Hemihydrate, Process II
Certificate Number : CEP 2021-385 - Rev 01
Status : Valid
Issue Date : 2024-02-06
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
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Temad- We think of world-class quality.
Date of Issue : 2019-01-02
Valid Till : 2021-01-02
Written Confirmation Number : 665/93733
Address of the Firm : 28th km of Karaj Makhsous Road, Tehran, Iran
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Temad- We think of world-class quality.
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 quality in the Midd...
Aspen API. More than just an API™
About the Company : Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen...
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...
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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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API Stability Enhancers
Coloring Agents
Soft Gelatin
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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 PROMETHAZINE VC W/ CODEINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PROMETHAZINE VC W/ CODEINE, including repackagers and relabelers. The FDA regulates PROMETHAZINE VC W/ CODEINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PROMETHAZINE VC W/ CODEINE 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 PROMETHAZINE VC W/ CODEINE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PROMETHAZINE VC W/ CODEINE supplier is an individual or a company that provides PROMETHAZINE VC W/ CODEINE active pharmaceutical ingredient (API) or PROMETHAZINE VC W/ CODEINE finished formulations upon request. The PROMETHAZINE VC W/ CODEINE suppliers may include PROMETHAZINE VC W/ CODEINE API manufacturers, exporters, distributors and traders.
click here to find a list of PROMETHAZINE VC W/ CODEINE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PROMETHAZINE VC W/ CODEINE DMF (Drug Master File) is a document detailing the whole manufacturing process of PROMETHAZINE VC W/ CODEINE active pharmaceutical ingredient (API) in detail. Different forms of PROMETHAZINE VC W/ CODEINE DMFs exist exist since differing nations have different regulations, such as PROMETHAZINE VC W/ CODEINE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PROMETHAZINE VC W/ CODEINE DMF submitted to regulatory agencies in the US is known as a USDMF. PROMETHAZINE VC W/ CODEINE USDMF includes data on PROMETHAZINE VC W/ CODEINE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PROMETHAZINE VC W/ CODEINE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PROMETHAZINE VC W/ CODEINE 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 PROMETHAZINE VC W/ CODEINE Drug Master File in Japan (PROMETHAZINE VC W/ CODEINE JDMF) empowers PROMETHAZINE VC W/ CODEINE 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 PROMETHAZINE VC W/ CODEINE JDMF during the approval evaluation for pharmaceutical products. At the time of PROMETHAZINE VC W/ CODEINE 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 PROMETHAZINE VC W/ CODEINE 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 PROMETHAZINE VC W/ CODEINE Drug Master File in Korea (PROMETHAZINE VC W/ CODEINE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of PROMETHAZINE VC W/ CODEINE. The MFDS reviews the PROMETHAZINE VC W/ CODEINE KDMF as part of the drug registration process and uses the information provided in the PROMETHAZINE VC W/ CODEINE KDMF to evaluate the safety and efficacy of the drug.
After submitting a PROMETHAZINE VC W/ CODEINE 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 PROMETHAZINE VC W/ CODEINE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of PROMETHAZINE VC W/ CODEINE suppliers with KDMF on PharmaCompass.
A PROMETHAZINE VC W/ CODEINE CEP of the European Pharmacopoeia monograph is often referred to as a PROMETHAZINE VC W/ CODEINE Certificate of Suitability (COS). The purpose of a PROMETHAZINE VC W/ CODEINE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PROMETHAZINE VC W/ CODEINE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PROMETHAZINE VC W/ CODEINE to their clients by showing that a PROMETHAZINE VC W/ CODEINE CEP has been issued for it. The manufacturer submits a PROMETHAZINE VC W/ CODEINE CEP (COS) as part of the market authorization procedure, and it takes on the role of a PROMETHAZINE VC W/ CODEINE CEP holder for the record. Additionally, the data presented in the PROMETHAZINE VC W/ CODEINE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PROMETHAZINE VC W/ CODEINE DMF.
A PROMETHAZINE VC W/ CODEINE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PROMETHAZINE VC W/ CODEINE 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 PROMETHAZINE VC W/ CODEINE suppliers with CEP (COS) on PharmaCompass.
A PROMETHAZINE VC W/ CODEINE written confirmation (PROMETHAZINE VC W/ CODEINE WC) is an official document issued by a regulatory agency to a PROMETHAZINE VC W/ CODEINE manufacturer, verifying that the manufacturing facility of a PROMETHAZINE VC W/ CODEINE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting PROMETHAZINE VC W/ CODEINE APIs or PROMETHAZINE VC W/ CODEINE finished pharmaceutical products to another nation, regulatory agencies frequently require a PROMETHAZINE VC W/ CODEINE WC (written confirmation) as part of the regulatory process.
click here to find a list of PROMETHAZINE VC W/ CODEINE 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 PROMETHAZINE VC W/ CODEINE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for PROMETHAZINE VC W/ CODEINE 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 PROMETHAZINE VC W/ CODEINE 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 PROMETHAZINE VC W/ CODEINE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PROMETHAZINE VC W/ CODEINE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of PROMETHAZINE VC W/ CODEINE suppliers with NDC on PharmaCompass.
PROMETHAZINE VC W/ CODEINE 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 PROMETHAZINE VC W/ CODEINE 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 PROMETHAZINE VC W/ CODEINE GMP manufacturer or PROMETHAZINE VC W/ CODEINE GMP API supplier for your needs.
A PROMETHAZINE VC W/ CODEINE CoA (Certificate of Analysis) is a formal document that attests to PROMETHAZINE VC W/ CODEINE's compliance with PROMETHAZINE VC W/ CODEINE specifications and serves as a tool for batch-level quality control.
PROMETHAZINE VC W/ CODEINE CoA mostly includes findings from lab analyses of a specific batch. For each PROMETHAZINE VC W/ CODEINE 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.
PROMETHAZINE VC W/ CODEINE may be tested according to a variety of international standards, such as European Pharmacopoeia (PROMETHAZINE VC W/ CODEINE EP), PROMETHAZINE VC W/ CODEINE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PROMETHAZINE VC W/ CODEINE USP).
