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API SUPPLIERS
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USDMF
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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Certificate Number : R1-CEP 2016-233 - Rev 00
Status : Valid
Issue Date : 2023-02-09
Type : Chemical
Substance Number : 254
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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Transo-Pharm, founded in 1987, is a fully licensed global distributor of pharmaceutical components for health and veterinary industries. It supports customers throughout the API li...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
About the Company : Malladi Drugs & Pharmaceuticals Ltd, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top API manufacturer in th...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
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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
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
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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, 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-Adrenaline bitartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of l-Adrenaline bitartrate, including repackagers and relabelers. The FDA regulates l-Adrenaline bitartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. l-Adrenaline 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 l-Adrenaline bitartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A l-Adrenaline bitartrate supplier is an individual or a company that provides l-Adrenaline bitartrate active pharmaceutical ingredient (API) or l-Adrenaline bitartrate finished formulations upon request. The l-Adrenaline bitartrate suppliers may include l-Adrenaline bitartrate API manufacturers, exporters, distributors and traders.
click here to find a list of l-Adrenaline bitartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A l-Adrenaline bitartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of l-Adrenaline bitartrate active pharmaceutical ingredient (API) in detail. Different forms of l-Adrenaline bitartrate DMFs exist exist since differing nations have different regulations, such as l-Adrenaline bitartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A l-Adrenaline bitartrate DMF submitted to regulatory agencies in the US is known as a USDMF. l-Adrenaline bitartrate USDMF includes data on l-Adrenaline bitartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The l-Adrenaline bitartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of l-Adrenaline 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 l-Adrenaline bitartrate Drug Master File in Japan (l-Adrenaline bitartrate JDMF) empowers l-Adrenaline 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 l-Adrenaline bitartrate JDMF during the approval evaluation for pharmaceutical products. At the time of l-Adrenaline 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 l-Adrenaline 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 l-Adrenaline bitartrate Drug Master File in Korea (l-Adrenaline bitartrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of l-Adrenaline bitartrate. The MFDS reviews the l-Adrenaline bitartrate KDMF as part of the drug registration process and uses the information provided in the l-Adrenaline bitartrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a l-Adrenaline 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 l-Adrenaline bitartrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of l-Adrenaline bitartrate suppliers with KDMF on PharmaCompass.
A l-Adrenaline bitartrate CEP of the European Pharmacopoeia monograph is often referred to as a l-Adrenaline bitartrate Certificate of Suitability (COS). The purpose of a l-Adrenaline bitartrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of l-Adrenaline bitartrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of l-Adrenaline bitartrate to their clients by showing that a l-Adrenaline bitartrate CEP has been issued for it. The manufacturer submits a l-Adrenaline bitartrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a l-Adrenaline bitartrate CEP holder for the record. Additionally, the data presented in the l-Adrenaline bitartrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the l-Adrenaline bitartrate DMF.
A l-Adrenaline bitartrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. l-Adrenaline 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 l-Adrenaline bitartrate suppliers with CEP (COS) on PharmaCompass.
A l-Adrenaline bitartrate written confirmation (l-Adrenaline bitartrate WC) is an official document issued by a regulatory agency to a l-Adrenaline bitartrate manufacturer, verifying that the manufacturing facility of a l-Adrenaline bitartrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting l-Adrenaline bitartrate APIs or l-Adrenaline bitartrate finished pharmaceutical products to another nation, regulatory agencies frequently require a l-Adrenaline bitartrate WC (written confirmation) as part of the regulatory process.
click here to find a list of l-Adrenaline 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 l-Adrenaline bitartrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for l-Adrenaline 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 l-Adrenaline 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 l-Adrenaline bitartrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a l-Adrenaline bitartrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of l-Adrenaline bitartrate suppliers with NDC on PharmaCompass.
l-Adrenaline 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 l-Adrenaline bitartrate 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-Adrenaline bitartrate GMP manufacturer or l-Adrenaline bitartrate GMP API supplier for your needs.
A l-Adrenaline bitartrate CoA (Certificate of Analysis) is a formal document that attests to l-Adrenaline bitartrate's compliance with l-Adrenaline bitartrate specifications and serves as a tool for batch-level quality control.
l-Adrenaline bitartrate CoA mostly includes findings from lab analyses of a specific batch. For each l-Adrenaline 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.
l-Adrenaline bitartrate may be tested according to a variety of international standards, such as European Pharmacopoeia (l-Adrenaline bitartrate EP), l-Adrenaline bitartrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (l-Adrenaline bitartrate USP).
