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API SUPPLIERS
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
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EU-WC
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
Jai Radhe Sales is your partner for all your sourcing needs.
Mesochem is focused on incessant innovation along with the R&D of new APIs.
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USDMF
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-16
Pay. Date : 2016-12-28
DMF Number : 30996
Submission : 2016-09-20
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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.
Date of Issue : 2022-02-22
Valid Till : 2025-07-15
Written Confirmation Number : TFDA-0002291
Address of the Firm : No. 168, Kai Yuan Rd, Hsin-Ying, Tainan City 73055, Taiwan
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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
About the Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufacturing ephedrine an...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Mesochem is focused on incessant innovation along with the R&D of new APIs.
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
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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 Medihaler-Epi manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Medihaler-Epi, including repackagers and relabelers. The FDA regulates Medihaler-Epi manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Medihaler-Epi 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 Medihaler-Epi manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Medihaler-Epi supplier is an individual or a company that provides Medihaler-Epi active pharmaceutical ingredient (API) or Medihaler-Epi finished formulations upon request. The Medihaler-Epi suppliers may include Medihaler-Epi API manufacturers, exporters, distributors and traders.
click here to find a list of Medihaler-Epi suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Medihaler-Epi DMF (Drug Master File) is a document detailing the whole manufacturing process of Medihaler-Epi active pharmaceutical ingredient (API) in detail. Different forms of Medihaler-Epi DMFs exist exist since differing nations have different regulations, such as Medihaler-Epi USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Medihaler-Epi DMF submitted to regulatory agencies in the US is known as a USDMF. Medihaler-Epi USDMF includes data on Medihaler-Epi's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Medihaler-Epi USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Medihaler-Epi 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 Medihaler-Epi Drug Master File in Japan (Medihaler-Epi JDMF) empowers Medihaler-Epi 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 Medihaler-Epi JDMF during the approval evaluation for pharmaceutical products. At the time of Medihaler-Epi 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 Medihaler-Epi 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 Medihaler-Epi Drug Master File in Korea (Medihaler-Epi KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Medihaler-Epi. The MFDS reviews the Medihaler-Epi KDMF as part of the drug registration process and uses the information provided in the Medihaler-Epi KDMF to evaluate the safety and efficacy of the drug.
After submitting a Medihaler-Epi 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 Medihaler-Epi API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Medihaler-Epi suppliers with KDMF on PharmaCompass.
A Medihaler-Epi CEP of the European Pharmacopoeia monograph is often referred to as a Medihaler-Epi Certificate of Suitability (COS). The purpose of a Medihaler-Epi CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Medihaler-Epi EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Medihaler-Epi to their clients by showing that a Medihaler-Epi CEP has been issued for it. The manufacturer submits a Medihaler-Epi CEP (COS) as part of the market authorization procedure, and it takes on the role of a Medihaler-Epi CEP holder for the record. Additionally, the data presented in the Medihaler-Epi CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Medihaler-Epi DMF.
A Medihaler-Epi CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Medihaler-Epi 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 Medihaler-Epi suppliers with CEP (COS) on PharmaCompass.
A Medihaler-Epi written confirmation (Medihaler-Epi WC) is an official document issued by a regulatory agency to a Medihaler-Epi manufacturer, verifying that the manufacturing facility of a Medihaler-Epi active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Medihaler-Epi APIs or Medihaler-Epi finished pharmaceutical products to another nation, regulatory agencies frequently require a Medihaler-Epi WC (written confirmation) as part of the regulatory process.
click here to find a list of Medihaler-Epi 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 Medihaler-Epi as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Medihaler-Epi 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 Medihaler-Epi 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 Medihaler-Epi and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Medihaler-Epi NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Medihaler-Epi suppliers with NDC on PharmaCompass.
Medihaler-Epi 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 Medihaler-Epi 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 Medihaler-Epi GMP manufacturer or Medihaler-Epi GMP API supplier for your needs.
A Medihaler-Epi CoA (Certificate of Analysis) is a formal document that attests to Medihaler-Epi's compliance with Medihaler-Epi specifications and serves as a tool for batch-level quality control.
Medihaler-Epi CoA mostly includes findings from lab analyses of a specific batch. For each Medihaler-Epi 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.
Medihaler-Epi may be tested according to a variety of international standards, such as European Pharmacopoeia (Medihaler-Epi EP), Medihaler-Epi JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Medihaler-Epi USP).
