Parand Darou Pharma Codeine Parand Darou Pharma Codeine


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Looking for 76-57-3 / Codeine API manufacturers, exporters & distributors?

Codeine manufacturers, exporters & distributors 1


PharmaCompass offers a list of Codeine 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 manufacturer or Codeine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Codeine manufacturer or Codeine supplier.

PharmaCompass also assists you with knowing the Codeine API Price utilized in the formulation of products. Codeine API Price is not always fixed or binding as the Codeine Price is obtained through a variety of data sources. The Codeine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name



Methylmorphine, Codeine anhydrous, Codicept, Coducept, L-codeine, 76-57-3

Cas Number


Unique Ingredient Identifier (UNII)


About Codeine

An opioid analgesic related to MORPHINE but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough.

Codeine Manufacturers

A Codeine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Codeine, including repackagers and relabelers. The FDA regulates Codeine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Codeine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Codeine Suppliers

A Codeine supplier is an individual or a company that provides Codeine active pharmaceutical ingredient (API) or Codeine finished formulations upon request. The Codeine suppliers may include Codeine API manufacturers, exporters, distributors and traders.

click here to find a list of Codeine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Codeine USDMF

A Codeine DMF (Drug Master File) is a document detailing the whole manufacturing process of Codeine active pharmaceutical ingredient (API) in detail. Different forms of Codeine DMFs exist exist since differing nations have different regulations, such as Codeine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Codeine DMF submitted to regulatory agencies in the US is known as a USDMF. Codeine USDMF includes data on Codeine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Codeine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Codeine suppliers with USDMF on PharmaCompass.

Codeine JDMF

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 Drug Master File in Japan (Codeine JDMF) empowers 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 Codeine JDMF during the approval evaluation for pharmaceutical products. At the time of 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 Codeine suppliers with JDMF on PharmaCompass.

Codeine CEP

A Codeine CEP of the European Pharmacopoeia monograph is often referred to as a Codeine Certificate of Suitability (COS). The purpose of a Codeine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Codeine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Codeine to their clients by showing that a Codeine CEP has been issued for it. The manufacturer submits a Codeine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Codeine CEP holder for the record. Additionally, the data presented in the Codeine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Codeine DMF.

A Codeine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 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 Codeine suppliers with CEP (COS) on PharmaCompass.

Codeine WC

A Codeine written confirmation (Codeine WC) is an official document issued by a regulatory agency to a Codeine manufacturer, verifying that the manufacturing facility of a Codeine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Codeine APIs or Codeine finished pharmaceutical products to another nation, regulatory agencies frequently require a Codeine WC (written confirmation) as part of the regulatory process.

click here to find a list of Codeine suppliers with Written Confirmation (WC) on PharmaCompass.

Codeine GMP

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 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 Codeine GMP manufacturer or Codeine GMP API supplier for your needs.

Codeine CoA

A Codeine CoA (Certificate of Analysis) is a formal document that attests to Codeine's compliance with Codeine specifications and serves as a tool for batch-level quality control.

Codeine CoA mostly includes findings from lab analyses of a specific batch. For each 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.

Codeine may be tested according to a variety of international standards, such as European Pharmacopoeia (Codeine EP), Codeine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Codeine USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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