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API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 15MG
USFDA APPLICATION NUMBER - 22402
DOSAGE - TABLET;ORAL - 30MG
USFDA APPLICATION NUMBER - 22402
DOSAGE - TABLET;ORAL - 60MG
USFDA APPLICATION NUMBER - 22402
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Codeine Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Codeine Sulfate, including repackagers and relabelers. The FDA regulates Codeine Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Codeine Sulfate 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 Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Codeine Sulfate supplier is an individual or a company that provides Codeine Sulfate active pharmaceutical ingredient (API) or Codeine Sulfate finished formulations upon request. The Codeine Sulfate suppliers may include Codeine Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Codeine Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Codeine Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Codeine Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Codeine Sulfate DMFs exist exist since differing nations have different regulations, such as Codeine Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Codeine Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Codeine Sulfate USDMF includes data on Codeine Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Codeine Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Codeine Sulfate suppliers with USDMF 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 Sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Codeine Sulfate 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 Sulfate 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 Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Codeine Sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Codeine Sulfate suppliers with NDC on PharmaCompass.
Codeine Sulfate 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 Sulfate 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 Sulfate GMP manufacturer or Codeine Sulfate GMP API supplier for your needs.
A Codeine Sulfate CoA (Certificate of Analysis) is a formal document that attests to Codeine Sulfate's compliance with Codeine Sulfate specifications and serves as a tool for batch-level quality control.
Codeine Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Codeine Sulfate 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 Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Codeine Sulfate EP), Codeine Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Codeine Sulfate USP).
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