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API SUPPLIERS
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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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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
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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 SOMA COMPOUND W/ CODEINE-2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SOMA COMPOUND W/ CODEINE-2, including repackagers and relabelers. The FDA regulates SOMA COMPOUND W/ CODEINE-2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SOMA COMPOUND W/ CODEINE-2 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 SOMA COMPOUND W/ CODEINE-2 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SOMA COMPOUND W/ CODEINE-2 supplier is an individual or a company that provides SOMA COMPOUND W/ CODEINE-2 active pharmaceutical ingredient (API) or SOMA COMPOUND W/ CODEINE-2 finished formulations upon request. The SOMA COMPOUND W/ CODEINE-2 suppliers may include SOMA COMPOUND W/ CODEINE-2 API manufacturers, exporters, distributors and traders.
click here to find a list of SOMA COMPOUND W/ CODEINE-2 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SOMA COMPOUND W/ CODEINE-2 DMF (Drug Master File) is a document detailing the whole manufacturing process of SOMA COMPOUND W/ CODEINE-2 active pharmaceutical ingredient (API) in detail. Different forms of SOMA COMPOUND W/ CODEINE-2 DMFs exist exist since differing nations have different regulations, such as SOMA COMPOUND W/ CODEINE-2 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SOMA COMPOUND W/ CODEINE-2 DMF submitted to regulatory agencies in the US is known as a USDMF. SOMA COMPOUND W/ CODEINE-2 USDMF includes data on SOMA COMPOUND W/ CODEINE-2's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SOMA COMPOUND W/ CODEINE-2 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SOMA COMPOUND W/ CODEINE-2 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 SOMA COMPOUND W/ CODEINE-2 Drug Master File in Japan (SOMA COMPOUND W/ CODEINE-2 JDMF) empowers SOMA COMPOUND W/ CODEINE-2 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 SOMA COMPOUND W/ CODEINE-2 JDMF during the approval evaluation for pharmaceutical products. At the time of SOMA COMPOUND W/ CODEINE-2 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 SOMA COMPOUND W/ CODEINE-2 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 SOMA COMPOUND W/ CODEINE-2 Drug Master File in Korea (SOMA COMPOUND W/ CODEINE-2 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SOMA COMPOUND W/ CODEINE-2. The MFDS reviews the SOMA COMPOUND W/ CODEINE-2 KDMF as part of the drug registration process and uses the information provided in the SOMA COMPOUND W/ CODEINE-2 KDMF to evaluate the safety and efficacy of the drug.
After submitting a SOMA COMPOUND W/ CODEINE-2 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 SOMA COMPOUND W/ CODEINE-2 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SOMA COMPOUND W/ CODEINE-2 suppliers with KDMF on PharmaCompass.
A SOMA COMPOUND W/ CODEINE-2 CEP of the European Pharmacopoeia monograph is often referred to as a SOMA COMPOUND W/ CODEINE-2 Certificate of Suitability (COS). The purpose of a SOMA COMPOUND W/ CODEINE-2 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of SOMA COMPOUND W/ CODEINE-2 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of SOMA COMPOUND W/ CODEINE-2 to their clients by showing that a SOMA COMPOUND W/ CODEINE-2 CEP has been issued for it. The manufacturer submits a SOMA COMPOUND W/ CODEINE-2 CEP (COS) as part of the market authorization procedure, and it takes on the role of a SOMA COMPOUND W/ CODEINE-2 CEP holder for the record. Additionally, the data presented in the SOMA COMPOUND W/ CODEINE-2 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the SOMA COMPOUND W/ CODEINE-2 DMF.
A SOMA COMPOUND W/ CODEINE-2 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. SOMA COMPOUND W/ CODEINE-2 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 SOMA COMPOUND W/ CODEINE-2 suppliers with CEP (COS) on PharmaCompass.
A SOMA COMPOUND W/ CODEINE-2 written confirmation (SOMA COMPOUND W/ CODEINE-2 WC) is an official document issued by a regulatory agency to a SOMA COMPOUND W/ CODEINE-2 manufacturer, verifying that the manufacturing facility of a SOMA COMPOUND W/ CODEINE-2 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SOMA COMPOUND W/ CODEINE-2 APIs or SOMA COMPOUND W/ CODEINE-2 finished pharmaceutical products to another nation, regulatory agencies frequently require a SOMA COMPOUND W/ CODEINE-2 WC (written confirmation) as part of the regulatory process.
click here to find a list of SOMA COMPOUND W/ CODEINE-2 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 SOMA COMPOUND W/ CODEINE-2 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SOMA COMPOUND W/ CODEINE-2 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 SOMA COMPOUND W/ CODEINE-2 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 SOMA COMPOUND W/ CODEINE-2 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SOMA COMPOUND W/ CODEINE-2 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SOMA COMPOUND W/ CODEINE-2 suppliers with NDC on PharmaCompass.
SOMA COMPOUND W/ CODEINE-2 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 SOMA COMPOUND W/ CODEINE-2 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 SOMA COMPOUND W/ CODEINE-2 GMP manufacturer or SOMA COMPOUND W/ CODEINE-2 GMP API supplier for your needs.
A SOMA COMPOUND W/ CODEINE-2 CoA (Certificate of Analysis) is a formal document that attests to SOMA COMPOUND W/ CODEINE-2's compliance with SOMA COMPOUND W/ CODEINE-2 specifications and serves as a tool for batch-level quality control.
SOMA COMPOUND W/ CODEINE-2 CoA mostly includes findings from lab analyses of a specific batch. For each SOMA COMPOUND W/ CODEINE-2 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.
SOMA COMPOUND W/ CODEINE-2 may be tested according to a variety of international standards, such as European Pharmacopoeia (SOMA COMPOUND W/ CODEINE-2 EP), SOMA COMPOUND W/ CODEINE-2 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SOMA COMPOUND W/ CODEINE-2 USP).
