X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
10
PharmaCompass offers a list of Ephedrine Hydrochloride 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 Ephedrine Hydrochloride manufacturer or Ephedrine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ephedrine Hydrochloride manufacturer or Ephedrine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Ephedrine Hydrochloride API Price utilized in the formulation of products. Ephedrine Hydrochloride API Price is not always fixed or binding as the Ephedrine Hydrochloride Price is obtained through a variety of data sources. The Ephedrine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Altusin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Altusin, including repackagers and relabelers. The FDA regulates Altusin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Altusin 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 Altusin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Altusin supplier is an individual or a company that provides Altusin active pharmaceutical ingredient (API) or Altusin finished formulations upon request. The Altusin suppliers may include Altusin API manufacturers, exporters, distributors and traders.
click here to find a list of Altusin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Altusin DMF (Drug Master File) is a document detailing the whole manufacturing process of Altusin active pharmaceutical ingredient (API) in detail. Different forms of Altusin DMFs exist exist since differing nations have different regulations, such as Altusin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Altusin DMF submitted to regulatory agencies in the US is known as a USDMF. Altusin USDMF includes data on Altusin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Altusin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Altusin 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 Altusin Drug Master File in Japan (Altusin JDMF) empowers Altusin 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 Altusin JDMF during the approval evaluation for pharmaceutical products. At the time of Altusin 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 Altusin 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 Altusin Drug Master File in Korea (Altusin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Altusin. The MFDS reviews the Altusin KDMF as part of the drug registration process and uses the information provided in the Altusin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Altusin 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 Altusin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Altusin suppliers with KDMF on PharmaCompass.
A Altusin CEP of the European Pharmacopoeia monograph is often referred to as a Altusin Certificate of Suitability (COS). The purpose of a Altusin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Altusin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Altusin to their clients by showing that a Altusin CEP has been issued for it. The manufacturer submits a Altusin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Altusin CEP holder for the record. Additionally, the data presented in the Altusin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Altusin DMF.
A Altusin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Altusin 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 Altusin suppliers with CEP (COS) on PharmaCompass.
A Altusin written confirmation (Altusin WC) is an official document issued by a regulatory agency to a Altusin manufacturer, verifying that the manufacturing facility of a Altusin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Altusin APIs or Altusin finished pharmaceutical products to another nation, regulatory agencies frequently require a Altusin WC (written confirmation) as part of the regulatory process.
click here to find a list of Altusin 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 Altusin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Altusin 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 Altusin 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 Altusin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Altusin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Altusin suppliers with NDC on PharmaCompass.
Altusin 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 Altusin 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 Altusin GMP manufacturer or Altusin GMP API supplier for your needs.
A Altusin CoA (Certificate of Analysis) is a formal document that attests to Altusin's compliance with Altusin specifications and serves as a tool for batch-level quality control.
Altusin CoA mostly includes findings from lab analyses of a specific batch. For each Altusin 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.
Altusin may be tested according to a variety of international standards, such as European Pharmacopoeia (Altusin EP), Altusin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Altusin USP).
Market Place
