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