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API SUPPLIERS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Veranova: A CDMO that manages complexity with confidence.
Aspen API. More than just an API™
Temad- We think of world-class quality.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
NDC
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
Veranova: A CDMO that manages complexity with confidence.
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20787
Submission : 2007-08-23
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-16
Pay. Date : 2012-11-23
DMF Number : 25856
Submission : 2012-03-30
Status :
Type : II
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : CEP 1997-118 - Rev 13
Status : Valid
Issue Date : 2025-10-20
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registrant Name : Nosa Chemical Co., Ltd.
Registration Date : 2020-06-16
Registration Number : 20200616-209-J-616
Manufacturer Name : Saneca Pharmaceuticals as
Manufacturer Address : Nitrianska 100, 920 27 Hlohovec, Slovak Republic
Veranova: A CDMO that manages complexity with confidence.
Registrant Name : Samung Industry Co., Ltd.
Registration Date : 2021-03-16
Registration Number : 20210316-209-J-603
Manufacturer Name : Macfarlan Smith Limited@Macf...
Manufacturer Address : Three Trees Road Newbie, Annan DG12 5QH United Kingdom@10 Wheatfield Road, Edinburgh,...
Veranova: A CDMO that manages complexity with confidence.
Registrant Name : Baeksu Pharmaceutical Co., Ltd.
Registration Date : 2021-03-16
Registration Number : 20210316-209-J-603(1)
Manufacturer Name : Macfarlan Smith Limited@Macf...
Manufacturer Address : Three Trees Road, Newbie, Annan Dumfriesshire, DG12 5QH, United Kingdom@10 Wheatfield...
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 ...
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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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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Tablet
Grade : Oral
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Parenteral
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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 PROMETHAZINE W/ CODEINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PROMETHAZINE W/ CODEINE, including repackagers and relabelers. The FDA regulates PROMETHAZINE W/ CODEINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PROMETHAZINE W/ 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 PROMETHAZINE W/ CODEINE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A PROMETHAZINE W/ CODEINE supplier is an individual or a company that provides PROMETHAZINE W/ CODEINE active pharmaceutical ingredient (API) or PROMETHAZINE W/ CODEINE finished formulations upon request. The PROMETHAZINE W/ CODEINE suppliers may include PROMETHAZINE W/ CODEINE API manufacturers, exporters, distributors and traders.
click here to find a list of PROMETHAZINE W/ CODEINE suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A PROMETHAZINE W/ CODEINE DMF (Drug Master File) is a document detailing the whole manufacturing process of PROMETHAZINE W/ CODEINE active pharmaceutical ingredient (API) in detail. Different forms of PROMETHAZINE W/ CODEINE DMFs exist exist since differing nations have different regulations, such as PROMETHAZINE W/ CODEINE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PROMETHAZINE W/ CODEINE DMF submitted to regulatory agencies in the US is known as a USDMF. PROMETHAZINE W/ CODEINE USDMF includes data on PROMETHAZINE W/ CODEINE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PROMETHAZINE W/ CODEINE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PROMETHAZINE W/ CODEINE 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 PROMETHAZINE W/ CODEINE Drug Master File in Japan (PROMETHAZINE W/ CODEINE JDMF) empowers PROMETHAZINE W/ 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 PROMETHAZINE W/ CODEINE JDMF during the approval evaluation for pharmaceutical products. At the time of PROMETHAZINE W/ 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 PROMETHAZINE W/ CODEINE 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 PROMETHAZINE W/ CODEINE Drug Master File in Korea (PROMETHAZINE W/ CODEINE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of PROMETHAZINE W/ CODEINE. The MFDS reviews the PROMETHAZINE W/ CODEINE KDMF as part of the drug registration process and uses the information provided in the PROMETHAZINE W/ CODEINE KDMF to evaluate the safety and efficacy of the drug.
After submitting a PROMETHAZINE W/ CODEINE 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 PROMETHAZINE W/ CODEINE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of PROMETHAZINE W/ CODEINE suppliers with KDMF on PharmaCompass.
A PROMETHAZINE W/ CODEINE CEP of the European Pharmacopoeia monograph is often referred to as a PROMETHAZINE W/ CODEINE Certificate of Suitability (COS). The purpose of a PROMETHAZINE W/ CODEINE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PROMETHAZINE W/ CODEINE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PROMETHAZINE W/ CODEINE to their clients by showing that a PROMETHAZINE W/ CODEINE CEP has been issued for it. The manufacturer submits a PROMETHAZINE W/ CODEINE CEP (COS) as part of the market authorization procedure, and it takes on the role of a PROMETHAZINE W/ CODEINE CEP holder for the record. Additionally, the data presented in the PROMETHAZINE W/ CODEINE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PROMETHAZINE W/ CODEINE DMF.
A PROMETHAZINE W/ CODEINE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PROMETHAZINE W/ 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 PROMETHAZINE W/ CODEINE suppliers with CEP (COS) on PharmaCompass.
A PROMETHAZINE W/ CODEINE written confirmation (PROMETHAZINE W/ CODEINE WC) is an official document issued by a regulatory agency to a PROMETHAZINE W/ CODEINE manufacturer, verifying that the manufacturing facility of a PROMETHAZINE W/ CODEINE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting PROMETHAZINE W/ CODEINE APIs or PROMETHAZINE W/ CODEINE finished pharmaceutical products to another nation, regulatory agencies frequently require a PROMETHAZINE W/ CODEINE WC (written confirmation) as part of the regulatory process.
click here to find a list of PROMETHAZINE W/ CODEINE 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 PROMETHAZINE W/ CODEINE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for PROMETHAZINE W/ CODEINE 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 PROMETHAZINE W/ CODEINE 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 PROMETHAZINE W/ CODEINE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PROMETHAZINE W/ CODEINE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of PROMETHAZINE W/ CODEINE suppliers with NDC on PharmaCompass.
PROMETHAZINE W/ 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 PROMETHAZINE W/ CODEINE GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right PROMETHAZINE W/ CODEINE GMP manufacturer or PROMETHAZINE W/ CODEINE GMP API supplier for your needs.
A PROMETHAZINE W/ CODEINE CoA (Certificate of Analysis) is a formal document that attests to PROMETHAZINE W/ CODEINE's compliance with PROMETHAZINE W/ CODEINE specifications and serves as a tool for batch-level quality control.
PROMETHAZINE W/ CODEINE CoA mostly includes findings from lab analyses of a specific batch. For each PROMETHAZINE W/ 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.
PROMETHAZINE W/ CODEINE may be tested according to a variety of international standards, such as European Pharmacopoeia (PROMETHAZINE W/ CODEINE EP), PROMETHAZINE W/ CODEINE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PROMETHAZINE W/ CODEINE USP).
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