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API SUPPLIERS
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USDMF
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DOSAGE - INJECTABLE;INJECTION - EQ 4MG PHOSPH...DOSAGE - INJECTABLE;INJECTION - EQ 4MG PHOSPHATE/ML
USFDA APPLICATION NUMBER - 84916
DOSAGE - INJECTABLE;INJECTION - EQ 4MG PHOSPH...DOSAGE - INJECTABLE;INJECTION - EQ 4MG PHOSPHATE/ML
USFDA APPLICATION NUMBER - 87440
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Nanjing Well Pharmaceutical
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PharmaCompass offers a list of Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate manufacturer or Dexamethasone Sodium Phosphate supplier for your needs.
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A Colvasone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Colvasone, including repackagers and relabelers. The FDA regulates Colvasone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Colvasone 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 Colvasone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Colvasone supplier is an individual or a company that provides Colvasone active pharmaceutical ingredient (API) or Colvasone finished formulations upon request. The Colvasone suppliers may include Colvasone API manufacturers, exporters, distributors and traders.
click here to find a list of Colvasone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Colvasone DMF (Drug Master File) is a document detailing the whole manufacturing process of Colvasone active pharmaceutical ingredient (API) in detail. Different forms of Colvasone DMFs exist exist since differing nations have different regulations, such as Colvasone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Colvasone DMF submitted to regulatory agencies in the US is known as a USDMF. Colvasone USDMF includes data on Colvasone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Colvasone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Colvasone 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 Colvasone Drug Master File in Japan (Colvasone JDMF) empowers Colvasone 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 Colvasone JDMF during the approval evaluation for pharmaceutical products. At the time of Colvasone 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 Colvasone 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 Colvasone Drug Master File in Korea (Colvasone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Colvasone. The MFDS reviews the Colvasone KDMF as part of the drug registration process and uses the information provided in the Colvasone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Colvasone 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 Colvasone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Colvasone suppliers with KDMF on PharmaCompass.
A Colvasone CEP of the European Pharmacopoeia monograph is often referred to as a Colvasone Certificate of Suitability (COS). The purpose of a Colvasone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Colvasone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Colvasone to their clients by showing that a Colvasone CEP has been issued for it. The manufacturer submits a Colvasone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Colvasone CEP holder for the record. Additionally, the data presented in the Colvasone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Colvasone DMF.
A Colvasone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Colvasone 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 Colvasone suppliers with CEP (COS) on PharmaCompass.
A Colvasone written confirmation (Colvasone WC) is an official document issued by a regulatory agency to a Colvasone manufacturer, verifying that the manufacturing facility of a Colvasone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Colvasone APIs or Colvasone finished pharmaceutical products to another nation, regulatory agencies frequently require a Colvasone WC (written confirmation) as part of the regulatory process.
click here to find a list of Colvasone 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 Colvasone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Colvasone 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 Colvasone 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 Colvasone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Colvasone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Colvasone suppliers with NDC on PharmaCompass.
Colvasone 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 Colvasone 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 Colvasone GMP manufacturer or Colvasone GMP API supplier for your needs.
A Colvasone CoA (Certificate of Analysis) is a formal document that attests to Colvasone's compliance with Colvasone specifications and serves as a tool for batch-level quality control.
Colvasone CoA mostly includes findings from lab analyses of a specific batch. For each Colvasone 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.
Colvasone may be tested according to a variety of international standards, such as European Pharmacopoeia (Colvasone EP), Colvasone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Colvasone USP).
