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USDMF
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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
Related Excipient Companies
Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
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ABOUT THIS PAGE
28
PharmaCompass offers a list of Epinephrine Bitartrate 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 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.
A L-tartaric acid; epinephrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-tartaric acid; epinephrine, including repackagers and relabelers. The FDA regulates L-tartaric acid; epinephrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-tartaric acid; epinephrine 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 L-tartaric acid; epinephrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A L-tartaric acid; epinephrine supplier is an individual or a company that provides L-tartaric acid; epinephrine active pharmaceutical ingredient (API) or L-tartaric acid; epinephrine finished formulations upon request. The L-tartaric acid; epinephrine suppliers may include L-tartaric acid; epinephrine API manufacturers, exporters, distributors and traders.
click here to find a list of L-tartaric acid; epinephrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A L-tartaric acid; epinephrine DMF (Drug Master File) is a document detailing the whole manufacturing process of L-tartaric acid; epinephrine active pharmaceutical ingredient (API) in detail. Different forms of L-tartaric acid; epinephrine DMFs exist exist since differing nations have different regulations, such as L-tartaric acid; epinephrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-tartaric acid; epinephrine DMF submitted to regulatory agencies in the US is known as a USDMF. L-tartaric acid; epinephrine USDMF includes data on L-tartaric acid; epinephrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-tartaric acid; epinephrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-tartaric acid; epinephrine 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 L-tartaric acid; epinephrine Drug Master File in Japan (L-tartaric acid; epinephrine JDMF) empowers L-tartaric acid; epinephrine 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 L-tartaric acid; epinephrine JDMF during the approval evaluation for pharmaceutical products. At the time of L-tartaric acid; epinephrine 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 L-tartaric acid; epinephrine 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 L-tartaric acid; epinephrine Drug Master File in Korea (L-tartaric acid; epinephrine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of L-tartaric acid; epinephrine. The MFDS reviews the L-tartaric acid; epinephrine KDMF as part of the drug registration process and uses the information provided in the L-tartaric acid; epinephrine KDMF to evaluate the safety and efficacy of the drug.
After submitting a L-tartaric acid; epinephrine 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 L-tartaric acid; epinephrine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of L-tartaric acid; epinephrine suppliers with KDMF on PharmaCompass.
A L-tartaric acid; epinephrine CEP of the European Pharmacopoeia monograph is often referred to as a L-tartaric acid; epinephrine Certificate of Suitability (COS). The purpose of a L-tartaric acid; epinephrine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-tartaric acid; epinephrine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-tartaric acid; epinephrine to their clients by showing that a L-tartaric acid; epinephrine CEP has been issued for it. The manufacturer submits a L-tartaric acid; epinephrine CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-tartaric acid; epinephrine CEP holder for the record. Additionally, the data presented in the L-tartaric acid; epinephrine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-tartaric acid; epinephrine DMF.
A L-tartaric acid; epinephrine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-tartaric acid; epinephrine 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 L-tartaric acid; epinephrine suppliers with CEP (COS) on PharmaCompass.
A L-tartaric acid; epinephrine written confirmation (L-tartaric acid; epinephrine WC) is an official document issued by a regulatory agency to a L-tartaric acid; epinephrine manufacturer, verifying that the manufacturing facility of a L-tartaric acid; epinephrine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting L-tartaric acid; epinephrine APIs or L-tartaric acid; epinephrine finished pharmaceutical products to another nation, regulatory agencies frequently require a L-tartaric acid; epinephrine WC (written confirmation) as part of the regulatory process.
click here to find a list of L-tartaric acid; epinephrine 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 L-tartaric acid; epinephrine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for L-tartaric acid; epinephrine 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 L-tartaric acid; epinephrine 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 L-tartaric acid; epinephrine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a L-tartaric acid; epinephrine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of L-tartaric acid; epinephrine suppliers with NDC on PharmaCompass.
L-tartaric acid; epinephrine 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 L-tartaric acid; epinephrine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right L-tartaric acid; epinephrine GMP manufacturer or L-tartaric acid; epinephrine GMP API supplier for your needs.
A L-tartaric acid; epinephrine CoA (Certificate of Analysis) is a formal document that attests to L-tartaric acid; epinephrine's compliance with L-tartaric acid; epinephrine specifications and serves as a tool for batch-level quality control.
L-tartaric acid; epinephrine CoA mostly includes findings from lab analyses of a specific batch. For each L-tartaric acid; epinephrine 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.
L-tartaric acid; epinephrine may be tested according to a variety of international standards, such as European Pharmacopoeia (L-tartaric acid; epinephrine EP), L-tartaric acid; epinephrine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-tartaric acid; epinephrine USP).
