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API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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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 - INJECTABLE;INJECTION - 0.25%
USFDA APPLICATION NUMBER - 16964
DOSAGE - INJECTABLE;INJECTION - 0.25%;0.0091M...DOSAGE - INJECTABLE;INJECTION - 0.25%;0.0091MG/ML
USFDA APPLICATION NUMBER - 16964
DOSAGE - INJECTABLE;INJECTION - 0.5%
USFDA APPLICATION NUMBER - 16964
DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG...DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG/ML
USFDA APPLICATION NUMBER - 16964
DOSAGE - INJECTABLE;INJECTION - 0.75%
USFDA APPLICATION NUMBER - 16964
DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091M...DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091MG/ML
USFDA APPLICATION NUMBER - 16964
DOSAGE - INJECTABLE;INJECTION - 0.25%
USFDA APPLICATION NUMBER - 18304
DOSAGE - INJECTABLE;INJECTION - 0.5%
USFDA APPLICATION NUMBER - 18304
DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG...DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG/ML
USFDA APPLICATION NUMBER - 18304
DOSAGE - INJECTABLE;INJECTION - 0.75%
USFDA APPLICATION NUMBER - 18304
DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091M...DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091MG/ML
USFDA APPLICATION NUMBER - 18304
DOSAGE - INJECTABLE;INJECTION - 4%; EQ 0.0085...DOSAGE - INJECTABLE;INJECTION - 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)
USFDA APPLICATION NUMBER - 20971
DOSAGE - INJECTABLE;INJECTION - 4%;EQ 0.017MG...DOSAGE - INJECTABLE;INJECTION - 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)
USFDA APPLICATION NUMBER - 20971
DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG...DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG/ML
USFDA APPLICATION NUMBER - 22046
DOSAGE - INJECTABLE;INJECTION - EQ 0.02MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.02MG BASE/ML;2%
USFDA APPLICATION NUMBER - 88389
DOSAGE - INJECTABLE;INJECTION - EQ 0.01MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.01MG BASE/ML;2%
USFDA APPLICATION NUMBER - 88390
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PharmaCompass offers a list of Epinephrine Bitartrate 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 Epinephrine Bitartrate manufacturer or Epinephrine Bitartrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Epinephrine Bitartrate manufacturer or Epinephrine Bitartrate supplier.
PharmaCompass also assists you with knowing the Epinephrine Bitartrate API Price utilized in the formulation of products. Epinephrine Bitartrate API Price is not always fixed or binding as the Epinephrine Bitartrate Price is obtained through a variety of data sources. The Epinephrine Bitartrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Epinephrine Tartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epinephrine Tartrate, including repackagers and relabelers. The FDA regulates Epinephrine Tartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epinephrine Tartrate 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 Epinephrine Tartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epinephrine Tartrate supplier is an individual or a company that provides Epinephrine Tartrate active pharmaceutical ingredient (API) or Epinephrine Tartrate finished formulations upon request. The Epinephrine Tartrate suppliers may include Epinephrine Tartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Epinephrine Tartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Epinephrine Tartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Epinephrine Tartrate active pharmaceutical ingredient (API) in detail. Different forms of Epinephrine Tartrate DMFs exist exist since differing nations have different regulations, such as Epinephrine Tartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Epinephrine Tartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Epinephrine Tartrate USDMF includes data on Epinephrine Tartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Epinephrine Tartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Epinephrine Tartrate 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 Epinephrine Tartrate Drug Master File in Japan (Epinephrine Tartrate JDMF) empowers Epinephrine Tartrate 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 Epinephrine Tartrate JDMF during the approval evaluation for pharmaceutical products. At the time of Epinephrine Tartrate 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 Epinephrine Tartrate 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 Epinephrine Tartrate Drug Master File in Korea (Epinephrine Tartrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Epinephrine Tartrate. The MFDS reviews the Epinephrine Tartrate KDMF as part of the drug registration process and uses the information provided in the Epinephrine Tartrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Epinephrine Tartrate 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 Epinephrine Tartrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Epinephrine Tartrate suppliers with KDMF on PharmaCompass.
A Epinephrine Tartrate CEP of the European Pharmacopoeia monograph is often referred to as a Epinephrine Tartrate Certificate of Suitability (COS). The purpose of a Epinephrine Tartrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Epinephrine Tartrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Epinephrine Tartrate to their clients by showing that a Epinephrine Tartrate CEP has been issued for it. The manufacturer submits a Epinephrine Tartrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Epinephrine Tartrate CEP holder for the record. Additionally, the data presented in the Epinephrine Tartrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Epinephrine Tartrate DMF.
A Epinephrine Tartrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Epinephrine Tartrate 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 Epinephrine Tartrate suppliers with CEP (COS) on PharmaCompass.
A Epinephrine Tartrate written confirmation (Epinephrine Tartrate WC) is an official document issued by a regulatory agency to a Epinephrine Tartrate manufacturer, verifying that the manufacturing facility of a Epinephrine Tartrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Epinephrine Tartrate APIs or Epinephrine Tartrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Epinephrine Tartrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Epinephrine Tartrate 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 Epinephrine Tartrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Epinephrine Tartrate 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 Epinephrine Tartrate 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 Epinephrine Tartrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Epinephrine Tartrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Epinephrine Tartrate suppliers with NDC on PharmaCompass.
Epinephrine Tartrate 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 Epinephrine Tartrate 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 Epinephrine Tartrate GMP manufacturer or Epinephrine Tartrate GMP API supplier for your needs.
A Epinephrine Tartrate CoA (Certificate of Analysis) is a formal document that attests to Epinephrine Tartrate's compliance with Epinephrine Tartrate specifications and serves as a tool for batch-level quality control.
Epinephrine Tartrate CoA mostly includes findings from lab analyses of a specific batch. For each Epinephrine Tartrate 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.
Epinephrine Tartrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Epinephrine Tartrate EP), Epinephrine Tartrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Epinephrine Tartrate USP).
