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USDMF
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : R1-CEP 2004-312 - Rev 01
Status : Valid
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 285
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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...
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...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
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...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...
Mesochem is focused on incessant innovation along with the R&D of new APIs.
About the Company : Beijing Mesochem Technology Co. Ltd., located in the Yizhuang National Economic and Technological Development Area, China, manufactures pharmaceutical chemicals, fine chemicals, an...
Trusted Partner for Innovative, Sustainable, and High-Quality API Development and Production.
About the Company : Alven Laboratories is a pharmaceutical company focused on the development, scale-up, and production of original and generic Active Pharmaceutical Ingredients (APIs). With expertise...
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PharmaCompass offers a list of Norepinephrine 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 Norepinephrine Bitartrate manufacturer or Norepinephrine Bitartrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Norepinephrine Bitartrate manufacturer or Norepinephrine Bitartrate supplier.
PharmaCompass also assists you with knowing the Norepinephrine Bitartrate API Price utilized in the formulation of products. Norepinephrine Bitartrate API Price is not always fixed or binding as the Norepinephrine Bitartrate Price is obtained through a variety of data sources. The Norepinephrine Bitartrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 893-91-4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 893-91-4, including repackagers and relabelers. The FDA regulates 893-91-4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 893-91-4 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 893-91-4 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 893-91-4 supplier is an individual or a company that provides 893-91-4 active pharmaceutical ingredient (API) or 893-91-4 finished formulations upon request. The 893-91-4 suppliers may include 893-91-4 API manufacturers, exporters, distributors and traders.
click here to find a list of 893-91-4 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 893-91-4 DMF (Drug Master File) is a document detailing the whole manufacturing process of 893-91-4 active pharmaceutical ingredient (API) in detail. Different forms of 893-91-4 DMFs exist exist since differing nations have different regulations, such as 893-91-4 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 893-91-4 DMF submitted to regulatory agencies in the US is known as a USDMF. 893-91-4 USDMF includes data on 893-91-4's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 893-91-4 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 893-91-4 suppliers with USDMF 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 893-91-4 Drug Master File in Korea (893-91-4 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 893-91-4. The MFDS reviews the 893-91-4 KDMF as part of the drug registration process and uses the information provided in the 893-91-4 KDMF to evaluate the safety and efficacy of the drug.
After submitting a 893-91-4 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 893-91-4 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 893-91-4 suppliers with KDMF on PharmaCompass.
A 893-91-4 CEP of the European Pharmacopoeia monograph is often referred to as a 893-91-4 Certificate of Suitability (COS). The purpose of a 893-91-4 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 893-91-4 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 893-91-4 to their clients by showing that a 893-91-4 CEP has been issued for it. The manufacturer submits a 893-91-4 CEP (COS) as part of the market authorization procedure, and it takes on the role of a 893-91-4 CEP holder for the record. Additionally, the data presented in the 893-91-4 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 893-91-4 DMF.
A 893-91-4 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 893-91-4 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 893-91-4 suppliers with CEP (COS) on PharmaCompass.
A 893-91-4 written confirmation (893-91-4 WC) is an official document issued by a regulatory agency to a 893-91-4 manufacturer, verifying that the manufacturing facility of a 893-91-4 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 893-91-4 APIs or 893-91-4 finished pharmaceutical products to another nation, regulatory agencies frequently require a 893-91-4 WC (written confirmation) as part of the regulatory process.
click here to find a list of 893-91-4 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 893-91-4 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 893-91-4 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 893-91-4 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 893-91-4 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 893-91-4 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 893-91-4 suppliers with NDC on PharmaCompass.
893-91-4 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 893-91-4 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 893-91-4 GMP manufacturer or 893-91-4 GMP API supplier for your needs.
A 893-91-4 CoA (Certificate of Analysis) is a formal document that attests to 893-91-4's compliance with 893-91-4 specifications and serves as a tool for batch-level quality control.
893-91-4 CoA mostly includes findings from lab analyses of a specific batch. For each 893-91-4 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.
893-91-4 may be tested according to a variety of international standards, such as European Pharmacopoeia (893-91-4 EP), 893-91-4 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (893-91-4 USP).
