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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION;INTRAVENOUS - 23.5MG/5ML (4...DOSAGE - SOLUTION;INTRAVENOUS - 23.5MG/5ML (4.7MG/ML)
USFDA APPLICATION NUMBER - 213536
DOSAGE - SOLUTION;INTRAVENOUS - 47MG/10ML (4....DOSAGE - SOLUTION;INTRAVENOUS - 47MG/10ML (4.7MG/ML)
USFDA APPLICATION NUMBER - 213536
DOSAGE - SOLUTION;INTRAVENOUS - 47MG/ML (47MG...DOSAGE - SOLUTION;INTRAVENOUS - 47MG/ML (47MG/ML)
USFDA APPLICATION NUMBER - 213536
DOSAGE - SOLUTION;INTRAVENOUS - 47MG/5ML (9.4...DOSAGE - SOLUTION;INTRAVENOUS - 47MG/5ML (9.4MG/ML)
USFDA APPLICATION NUMBER - 213536
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ephedrine Hydrochloride 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 Ephedrine Hydrochloride manufacturer or Ephedrine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ephedrine Hydrochloride manufacturer or Ephedrine Hydrochloride supplier.
A Ephedrini hydrochloridum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ephedrini hydrochloridum, including repackagers and relabelers. The FDA regulates Ephedrini hydrochloridum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ephedrini hydrochloridum 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 Ephedrini hydrochloridum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ephedrini hydrochloridum supplier is an individual or a company that provides Ephedrini hydrochloridum active pharmaceutical ingredient (API) or Ephedrini hydrochloridum finished formulations upon request. The Ephedrini hydrochloridum suppliers may include Ephedrini hydrochloridum API manufacturers, exporters, distributors and traders.
click here to find a list of Ephedrini hydrochloridum suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ephedrini hydrochloridum DMF (Drug Master File) is a document detailing the whole manufacturing process of Ephedrini hydrochloridum active pharmaceutical ingredient (API) in detail. Different forms of Ephedrini hydrochloridum DMFs exist exist since differing nations have different regulations, such as Ephedrini hydrochloridum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ephedrini hydrochloridum DMF submitted to regulatory agencies in the US is known as a USDMF. Ephedrini hydrochloridum USDMF includes data on Ephedrini hydrochloridum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ephedrini hydrochloridum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ephedrini hydrochloridum 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 Ephedrini hydrochloridum Drug Master File in Japan (Ephedrini hydrochloridum JDMF) empowers Ephedrini hydrochloridum 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 Ephedrini hydrochloridum JDMF during the approval evaluation for pharmaceutical products. At the time of Ephedrini hydrochloridum 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 Ephedrini hydrochloridum 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 Ephedrini hydrochloridum Drug Master File in Korea (Ephedrini hydrochloridum KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ephedrini hydrochloridum. The MFDS reviews the Ephedrini hydrochloridum KDMF as part of the drug registration process and uses the information provided in the Ephedrini hydrochloridum KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ephedrini hydrochloridum 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 Ephedrini hydrochloridum API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ephedrini hydrochloridum suppliers with KDMF on PharmaCompass.
A Ephedrini hydrochloridum CEP of the European Pharmacopoeia monograph is often referred to as a Ephedrini hydrochloridum Certificate of Suitability (COS). The purpose of a Ephedrini hydrochloridum CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ephedrini hydrochloridum EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ephedrini hydrochloridum to their clients by showing that a Ephedrini hydrochloridum CEP has been issued for it. The manufacturer submits a Ephedrini hydrochloridum CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ephedrini hydrochloridum CEP holder for the record. Additionally, the data presented in the Ephedrini hydrochloridum CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ephedrini hydrochloridum DMF.
A Ephedrini hydrochloridum CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ephedrini hydrochloridum 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 Ephedrini hydrochloridum suppliers with CEP (COS) on PharmaCompass.
A Ephedrini hydrochloridum written confirmation (Ephedrini hydrochloridum WC) is an official document issued by a regulatory agency to a Ephedrini hydrochloridum manufacturer, verifying that the manufacturing facility of a Ephedrini hydrochloridum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ephedrini hydrochloridum APIs or Ephedrini hydrochloridum finished pharmaceutical products to another nation, regulatory agencies frequently require a Ephedrini hydrochloridum WC (written confirmation) as part of the regulatory process.
click here to find a list of Ephedrini hydrochloridum 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 Ephedrini hydrochloridum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ephedrini hydrochloridum 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 Ephedrini hydrochloridum 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 Ephedrini hydrochloridum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ephedrini hydrochloridum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ephedrini hydrochloridum suppliers with NDC on PharmaCompass.
Ephedrini hydrochloridum 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 Ephedrini hydrochloridum GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ephedrini hydrochloridum GMP manufacturer or Ephedrini hydrochloridum GMP API supplier for your needs.
A Ephedrini hydrochloridum CoA (Certificate of Analysis) is a formal document that attests to Ephedrini hydrochloridum's compliance with Ephedrini hydrochloridum specifications and serves as a tool for batch-level quality control.
Ephedrini hydrochloridum CoA mostly includes findings from lab analyses of a specific batch. For each Ephedrini hydrochloridum 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.
Ephedrini hydrochloridum may be tested according to a variety of international standards, such as European Pharmacopoeia (Ephedrini hydrochloridum EP), Ephedrini hydrochloridum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ephedrini hydrochloridum USP).
