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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 200MG;30MG
USFDA APPLICATION NUMBER - 19771
DOSAGE - CAPSULE;ORAL - 8MG;60MG **Federal Re...DOSAGE - CAPSULE;ORAL - 8MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19806
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240MG
USFDA APPLICATION NUMBER - 20021
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG
USFDA APPLICATION NUMBER - 20786
DOSAGE - CAPSULE;ORAL - EQ 200MG FREE ACID AN...DOSAGE - CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
USFDA APPLICATION NUMBER - 21374
DOSAGE - TABLET;ORAL - 2MG;200MG;30MG
USFDA APPLICATION NUMBER - 21441
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2G...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG
USFDA APPLICATION NUMBER - 21585
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG
USFDA APPLICATION NUMBER - 21585
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG
USFDA APPLICATION NUMBER - 21704
DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;...DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML
USFDA APPLICATION NUMBER - 22279
DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG...DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22439
DOSAGE - SOLUTION;ORAL - 5MG/5ML;60MG/5ML **F...DOSAGE - SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22442
DOSAGE - SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5...DOSAGE - SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML
USFDA APPLICATION NUMBER - 88811
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ABOUT THIS PAGE
48
PharmaCompass offers a list of Pseudoephedrine 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 Pseudoephedrine Hydrochloride manufacturer or Pseudoephedrine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pseudoephedrine Hydrochloride manufacturer or Pseudoephedrine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Pseudoephedrine Hydrochloride API Price utilized in the formulation of products. Pseudoephedrine Hydrochloride API Price is not always fixed or binding as the Pseudoephedrine Hydrochloride Price is obtained through a variety of data sources. The Pseudoephedrine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A (+)-psi-Ephedrine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (+)-psi-Ephedrine hydrochloride, including repackagers and relabelers. The FDA regulates (+)-psi-Ephedrine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (+)-psi-Ephedrine hydrochloride 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 (+)-psi-Ephedrine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (+)-psi-Ephedrine hydrochloride supplier is an individual or a company that provides (+)-psi-Ephedrine hydrochloride active pharmaceutical ingredient (API) or (+)-psi-Ephedrine hydrochloride finished formulations upon request. The (+)-psi-Ephedrine hydrochloride suppliers may include (+)-psi-Ephedrine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of (+)-psi-Ephedrine hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (+)-psi-Ephedrine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of (+)-psi-Ephedrine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of (+)-psi-Ephedrine hydrochloride DMFs exist exist since differing nations have different regulations, such as (+)-psi-Ephedrine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (+)-psi-Ephedrine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. (+)-psi-Ephedrine hydrochloride USDMF includes data on (+)-psi-Ephedrine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (+)-psi-Ephedrine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (+)-psi-Ephedrine hydrochloride 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 (+)-psi-Ephedrine hydrochloride Drug Master File in Japan ((+)-psi-Ephedrine hydrochloride JDMF) empowers (+)-psi-Ephedrine hydrochloride 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 (+)-psi-Ephedrine hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of (+)-psi-Ephedrine hydrochloride 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 (+)-psi-Ephedrine hydrochloride 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 (+)-psi-Ephedrine hydrochloride Drug Master File in Korea ((+)-psi-Ephedrine hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (+)-psi-Ephedrine hydrochloride. The MFDS reviews the (+)-psi-Ephedrine hydrochloride KDMF as part of the drug registration process and uses the information provided in the (+)-psi-Ephedrine hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a (+)-psi-Ephedrine hydrochloride 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 (+)-psi-Ephedrine hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of (+)-psi-Ephedrine hydrochloride suppliers with KDMF on PharmaCompass.
A (+)-psi-Ephedrine hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a (+)-psi-Ephedrine hydrochloride Certificate of Suitability (COS). The purpose of a (+)-psi-Ephedrine hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of (+)-psi-Ephedrine hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of (+)-psi-Ephedrine hydrochloride to their clients by showing that a (+)-psi-Ephedrine hydrochloride CEP has been issued for it. The manufacturer submits a (+)-psi-Ephedrine hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a (+)-psi-Ephedrine hydrochloride CEP holder for the record. Additionally, the data presented in the (+)-psi-Ephedrine hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the (+)-psi-Ephedrine hydrochloride DMF.
A (+)-psi-Ephedrine hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (+)-psi-Ephedrine hydrochloride 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 (+)-psi-Ephedrine hydrochloride suppliers with CEP (COS) on PharmaCompass.
A (+)-psi-Ephedrine hydrochloride written confirmation ((+)-psi-Ephedrine hydrochloride WC) is an official document issued by a regulatory agency to a (+)-psi-Ephedrine hydrochloride manufacturer, verifying that the manufacturing facility of a (+)-psi-Ephedrine hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (+)-psi-Ephedrine hydrochloride APIs or (+)-psi-Ephedrine hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a (+)-psi-Ephedrine hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of (+)-psi-Ephedrine hydrochloride 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 (+)-psi-Ephedrine hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for (+)-psi-Ephedrine hydrochloride 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 (+)-psi-Ephedrine hydrochloride 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 (+)-psi-Ephedrine hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a (+)-psi-Ephedrine hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of (+)-psi-Ephedrine hydrochloride suppliers with NDC on PharmaCompass.
(+)-psi-Ephedrine hydrochloride 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 (+)-psi-Ephedrine hydrochloride 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 (+)-psi-Ephedrine hydrochloride GMP manufacturer or (+)-psi-Ephedrine hydrochloride GMP API supplier for your needs.
A (+)-psi-Ephedrine hydrochloride CoA (Certificate of Analysis) is a formal document that attests to (+)-psi-Ephedrine hydrochloride's compliance with (+)-psi-Ephedrine hydrochloride specifications and serves as a tool for batch-level quality control.
(+)-psi-Ephedrine hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each (+)-psi-Ephedrine hydrochloride 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.
(+)-psi-Ephedrine hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia ((+)-psi-Ephedrine hydrochloride EP), (+)-psi-Ephedrine hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia ((+)-psi-Ephedrine hydrochloride USP).
