Synopsis
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
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
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Cerata Pharmaceuticals LLP
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Avesta Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gloria Interchem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Symrise
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Direct Compression
Thickeners and Stabilizers
Disintegrants & Superdisintegrants
Granulation
Solubilizers
Parenteral
Topical
Lubricants & Glidants
Taste Masking
Film Formers & Plasticizers
Controlled & Modified Release
Co-Processed Excipients
Chewable & Orodispersible Aids
Coating Systems & Additives
Emulsifying Agents
API Stability Enhancers
Empty Capsules
Surfactant & Foaming Agents
Rheology Modifiers
Soft Gelatin
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
64
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 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, and COA 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, and COA 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.
A Codeine Phosphate Hemihydrate written confirmation (Codeine Phosphate Hemihydrate WC) is an official document issued by a regulatory agency to a Codeine Phosphate Hemihydrate manufacturer, verifying that the manufacturing facility of a Codeine Phosphate Hemihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Codeine Phosphate Hemihydrate APIs or Codeine Phosphate Hemihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Codeine Phosphate Hemihydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Codeine Phosphate Hemihydrate 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 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, 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).
