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USDMF
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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : CEP 2001-284 - Rev 04
Status : Valid
Issue Date : 2025-07-24
Type : Chemical
Substance Number : 662
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Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
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PharmaCompass offers a list of Daunorubicin HCl 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 Daunorubicin HCl manufacturer or Daunorubicin HCl supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Daunorubicin HCl manufacturer or Daunorubicin HCl supplier.
PharmaCompass also assists you with knowing the Daunorubicin HCl API Price utilized in the formulation of products. Daunorubicin HCl API Price is not always fixed or binding as the Daunorubicin HCl Price is obtained through a variety of data sources. The Daunorubicin HCl Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rubidomycin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rubidomycin Hydrochloride, including repackagers and relabelers. The FDA regulates Rubidomycin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rubidomycin Hydrochloride 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 Rubidomycin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rubidomycin Hydrochloride supplier is an individual or a company that provides Rubidomycin Hydrochloride active pharmaceutical ingredient (API) or Rubidomycin Hydrochloride finished formulations upon request. The Rubidomycin Hydrochloride suppliers may include Rubidomycin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Rubidomycin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rubidomycin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Rubidomycin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Rubidomycin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Rubidomycin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rubidomycin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Rubidomycin Hydrochloride USDMF includes data on Rubidomycin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rubidomycin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rubidomycin Hydrochloride 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 Rubidomycin Hydrochloride Drug Master File in Japan (Rubidomycin Hydrochloride JDMF) empowers Rubidomycin Hydrochloride 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 Rubidomycin Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Rubidomycin Hydrochloride 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 Rubidomycin Hydrochloride 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 Rubidomycin Hydrochloride Drug Master File in Korea (Rubidomycin Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rubidomycin Hydrochloride. The MFDS reviews the Rubidomycin Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Rubidomycin Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rubidomycin Hydrochloride 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 Rubidomycin Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rubidomycin Hydrochloride suppliers with KDMF on PharmaCompass.
A Rubidomycin Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Rubidomycin Hydrochloride Certificate of Suitability (COS). The purpose of a Rubidomycin Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rubidomycin Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rubidomycin Hydrochloride to their clients by showing that a Rubidomycin Hydrochloride CEP has been issued for it. The manufacturer submits a Rubidomycin Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rubidomycin Hydrochloride CEP holder for the record. Additionally, the data presented in the Rubidomycin Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rubidomycin Hydrochloride DMF.
A Rubidomycin Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rubidomycin Hydrochloride 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 Rubidomycin Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Rubidomycin Hydrochloride written confirmation (Rubidomycin Hydrochloride WC) is an official document issued by a regulatory agency to a Rubidomycin Hydrochloride manufacturer, verifying that the manufacturing facility of a Rubidomycin Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rubidomycin Hydrochloride APIs or Rubidomycin Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Rubidomycin Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Rubidomycin Hydrochloride 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 Rubidomycin Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rubidomycin Hydrochloride 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 Rubidomycin Hydrochloride 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 Rubidomycin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rubidomycin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rubidomycin Hydrochloride suppliers with NDC on PharmaCompass.
Rubidomycin Hydrochloride 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 Rubidomycin Hydrochloride 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 Rubidomycin Hydrochloride GMP manufacturer or Rubidomycin Hydrochloride GMP API supplier for your needs.
A Rubidomycin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Rubidomycin Hydrochloride's compliance with Rubidomycin Hydrochloride specifications and serves as a tool for batch-level quality control.
Rubidomycin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Rubidomycin Hydrochloride 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.
Rubidomycin Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Rubidomycin Hydrochloride EP), Rubidomycin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rubidomycin Hydrochloride USP).
