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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**Federal Re...DOSAGE - CAPSULE;ORAL - 8MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**F...DOSAGE - SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1, including repackagers and relabelers. The FDA regulates TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 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 TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 supplier is an individual or a company that provides TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 active pharmaceutical ingredient (API) or TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 finished formulations upon request. The TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 suppliers may include TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 API manufacturers, exporters, distributors and traders.
click here to find a list of TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 active pharmaceutical ingredient (API) in detail. Different forms of TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 DMFs exist exist since differing nations have different regulations, such as TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 DMF submitted to regulatory agencies in the US is known as a USDMF. TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 USDMF includes data on TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 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 TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 Drug Master File in Japan (TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 JDMF) empowers TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 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 TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 JDMF during the approval evaluation for pharmaceutical products. At the time of TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 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 TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 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 TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 Drug Master File in Korea (TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1. The MFDS reviews the TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 KDMF as part of the drug registration process and uses the information provided in the TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 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 TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 suppliers with KDMF on PharmaCompass.
A TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 CEP of the European Pharmacopoeia monograph is often referred to as a TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 Certificate of Suitability (COS). The purpose of a TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 to their clients by showing that a TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 CEP has been issued for it. The manufacturer submits a TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 CEP holder for the record. Additionally, the data presented in the TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 DMF.
A TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 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 TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 suppliers with CEP (COS) on PharmaCompass.
A TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 written confirmation (TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 WC) is an official document issued by a regulatory agency to a TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 manufacturer, verifying that the manufacturing facility of a TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 APIs or TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 finished pharmaceutical products to another nation, regulatory agencies frequently require a TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 WC (written confirmation) as part of the regulatory process.
click here to find a list of TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 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 TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 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 TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 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 TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 suppliers with NDC on PharmaCompass.
TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 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 TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 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 TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 GMP manufacturer or TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 GMP API supplier for your needs.
A TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 CoA (Certificate of Analysis) is a formal document that attests to TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1's compliance with TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 specifications and serves as a tool for batch-level quality control.
TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 CoA mostly includes findings from lab analyses of a specific batch. For each TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 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.
TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 EP), TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL; CODEINE PHOSPHATE-1 USP).
