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