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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...
Aspen API. More than just an API™
About the Company : Aspen API is a cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. The company supplies a broad portfolio of over 50 high-qual...
Temad- We think of world-class quality.
About the Company : Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. It complies with Ira...
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
About the Company : Noramco, founded in 1979, specializes in developing and manufacturing APIs for opioid and non-opioid products. It excels in controlled substance development, offering supply-chain ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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Temad- We think of world-class quality.
Regulatory Info :
Registration Country : Iran
Guaifenesin; Pseudoephedrine Hydrochloride; Codeine Phosphate
Brand Name : Expectorant Codeine
Dosage Form : Syrup
Dosage Strength : 100MG; 30MG; 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Temad- We think of world-class quality.
Regulatory Info :
Registration Country : Iran
Guaifenesin; Codeine Phosphate
Brand Name : Guaicodin
Dosage Form : Syrup
Dosage Strength : 100MG; 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Regulatory Info :
Registration Country : India
Codeine Phosphate; Paracetamol
Brand Name : Codeine Phosphate; Par...
Dosage Form : Tablet
Dosage Strength : 8MG; 500MG
Packaging : Pack Size 10x10
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Regulatory Info :
Registration Country : India
Codeine Phosphate; Paracetamol
Brand Name : Codeine Phosphate; Par...
Dosage Form : Tablet
Dosage Strength : 30MG; 500MG
Packaging : Pack Size 10x10
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate
Brand Name : Acetaminophen; Butalbi...
Dosage Form : Tablet
Dosage Strength : 50MG; 325MG; 40MG; 30M...
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Aspirin; Butalbital; Caffeine; Codeine Phosphate
Brand Name : Aspirin; Butalbital; C...
Dosage Form : Tablet
Dosage Strength : 50MG; 325MG; 40MG; 30M...
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - CAPSULE;ORAL - 325MG;50MG;40MG;30MG ...DOSAGE - CAPSULE;ORAL - 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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 **F...DOSAGE - SYRUP;ORAL - 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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, 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.
A FIORINAL W/CODEINE-3 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of FIORINAL W/CODEINE-3, including repackagers and relabelers. The FDA regulates FIORINAL W/CODEINE-3 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. FIORINAL W/CODEINE-3 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 FIORINAL W/CODEINE-3 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A FIORINAL W/CODEINE-3 supplier is an individual or a company that provides FIORINAL W/CODEINE-3 active pharmaceutical ingredient (API) or FIORINAL W/CODEINE-3 finished formulations upon request. The FIORINAL W/CODEINE-3 suppliers may include FIORINAL W/CODEINE-3 API manufacturers, exporters, distributors and traders.
click here to find a list of FIORINAL W/CODEINE-3 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A FIORINAL W/CODEINE-3 DMF (Drug Master File) is a document detailing the whole manufacturing process of FIORINAL W/CODEINE-3 active pharmaceutical ingredient (API) in detail. Different forms of FIORINAL W/CODEINE-3 DMFs exist exist since differing nations have different regulations, such as FIORINAL W/CODEINE-3 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A FIORINAL W/CODEINE-3 DMF submitted to regulatory agencies in the US is known as a USDMF. FIORINAL W/CODEINE-3 USDMF includes data on FIORINAL W/CODEINE-3's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The FIORINAL W/CODEINE-3 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of FIORINAL W/CODEINE-3 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 FIORINAL W/CODEINE-3 Drug Master File in Japan (FIORINAL W/CODEINE-3 JDMF) empowers FIORINAL W/CODEINE-3 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 FIORINAL W/CODEINE-3 JDMF during the approval evaluation for pharmaceutical products. At the time of FIORINAL W/CODEINE-3 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 FIORINAL W/CODEINE-3 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 FIORINAL W/CODEINE-3 Drug Master File in Korea (FIORINAL W/CODEINE-3 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of FIORINAL W/CODEINE-3. The MFDS reviews the FIORINAL W/CODEINE-3 KDMF as part of the drug registration process and uses the information provided in the FIORINAL W/CODEINE-3 KDMF to evaluate the safety and efficacy of the drug.
After submitting a FIORINAL W/CODEINE-3 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 FIORINAL W/CODEINE-3 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of FIORINAL W/CODEINE-3 suppliers with KDMF on PharmaCompass.
A FIORINAL W/CODEINE-3 CEP of the European Pharmacopoeia monograph is often referred to as a FIORINAL W/CODEINE-3 Certificate of Suitability (COS). The purpose of a FIORINAL W/CODEINE-3 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of FIORINAL W/CODEINE-3 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of FIORINAL W/CODEINE-3 to their clients by showing that a FIORINAL W/CODEINE-3 CEP has been issued for it. The manufacturer submits a FIORINAL W/CODEINE-3 CEP (COS) as part of the market authorization procedure, and it takes on the role of a FIORINAL W/CODEINE-3 CEP holder for the record. Additionally, the data presented in the FIORINAL W/CODEINE-3 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the FIORINAL W/CODEINE-3 DMF.
A FIORINAL W/CODEINE-3 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. FIORINAL W/CODEINE-3 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 FIORINAL W/CODEINE-3 suppliers with CEP (COS) on PharmaCompass.
A FIORINAL W/CODEINE-3 written confirmation (FIORINAL W/CODEINE-3 WC) is an official document issued by a regulatory agency to a FIORINAL W/CODEINE-3 manufacturer, verifying that the manufacturing facility of a FIORINAL W/CODEINE-3 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting FIORINAL W/CODEINE-3 APIs or FIORINAL W/CODEINE-3 finished pharmaceutical products to another nation, regulatory agencies frequently require a FIORINAL W/CODEINE-3 WC (written confirmation) as part of the regulatory process.
click here to find a list of FIORINAL W/CODEINE-3 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 FIORINAL W/CODEINE-3 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for FIORINAL W/CODEINE-3 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 FIORINAL W/CODEINE-3 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 FIORINAL W/CODEINE-3 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a FIORINAL W/CODEINE-3 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of FIORINAL W/CODEINE-3 suppliers with NDC on PharmaCompass.
FIORINAL W/CODEINE-3 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 FIORINAL W/CODEINE-3 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right FIORINAL W/CODEINE-3 GMP manufacturer or FIORINAL W/CODEINE-3 GMP API supplier for your needs.
A FIORINAL W/CODEINE-3 CoA (Certificate of Analysis) is a formal document that attests to FIORINAL W/CODEINE-3's compliance with FIORINAL W/CODEINE-3 specifications and serves as a tool for batch-level quality control.
FIORINAL W/CODEINE-3 CoA mostly includes findings from lab analyses of a specific batch. For each FIORINAL W/CODEINE-3 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.
FIORINAL W/CODEINE-3 may be tested according to a variety of international standards, such as European Pharmacopoeia (FIORINAL W/CODEINE-3 EP), FIORINAL W/CODEINE-3 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (FIORINAL W/CODEINE-3 USP).
