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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
FDF
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Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33575
Submission : 2019-03-25
Status :
Type : II
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-28
Pay. Date : 2019-04-25
DMF Number : 32402
Submission : 2018-01-04
Status :
Type : II
With Virupaksha, you get a quality product with on-time delivery.
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-23
Pay. Date : 2024-08-19
DMF Number : 39295
Submission : 2024-01-23
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 30MG HYDROBROMIDE/5ML
USFDA APPLICATION NUMBER - 18658
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG;600MG
USFDA APPLICATION NUMBER - 21620
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;1.2GM
USFDA APPLICATION NUMBER - 21620
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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EUROAPI
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Dextromethorphan Hydrobromide 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 Dextromethorphan Hydrobromide manufacturer or Dextromethorphan Hydrobromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dextromethorphan Hydrobromide manufacturer or Dextromethorphan Hydrobromide supplier.
PharmaCompass also assists you with knowing the Dextromethorphan Hydrobromide API Price utilized in the formulation of products. Dextromethorphan Hydrobromide API Price is not always fixed or binding as the Dextromethorphan Hydrobromide Price is obtained through a variety of data sources. The Dextromethorphan Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Medicon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Medicon, including repackagers and relabelers. The FDA regulates Medicon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Medicon 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 Medicon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Medicon supplier is an individual or a company that provides Medicon active pharmaceutical ingredient (API) or Medicon finished formulations upon request. The Medicon suppliers may include Medicon API manufacturers, exporters, distributors and traders.
click here to find a list of Medicon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Medicon DMF (Drug Master File) is a document detailing the whole manufacturing process of Medicon active pharmaceutical ingredient (API) in detail. Different forms of Medicon DMFs exist exist since differing nations have different regulations, such as Medicon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Medicon DMF submitted to regulatory agencies in the US is known as a USDMF. Medicon USDMF includes data on Medicon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Medicon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Medicon 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 Medicon Drug Master File in Japan (Medicon JDMF) empowers Medicon 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 Medicon JDMF during the approval evaluation for pharmaceutical products. At the time of Medicon 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 Medicon 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 Medicon Drug Master File in Korea (Medicon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Medicon. The MFDS reviews the Medicon KDMF as part of the drug registration process and uses the information provided in the Medicon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Medicon 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 Medicon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Medicon suppliers with KDMF on PharmaCompass.
A Medicon CEP of the European Pharmacopoeia monograph is often referred to as a Medicon Certificate of Suitability (COS). The purpose of a Medicon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Medicon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Medicon to their clients by showing that a Medicon CEP has been issued for it. The manufacturer submits a Medicon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Medicon CEP holder for the record. Additionally, the data presented in the Medicon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Medicon DMF.
A Medicon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Medicon 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 Medicon suppliers with CEP (COS) on PharmaCompass.
A Medicon written confirmation (Medicon WC) is an official document issued by a regulatory agency to a Medicon manufacturer, verifying that the manufacturing facility of a Medicon active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Medicon APIs or Medicon finished pharmaceutical products to another nation, regulatory agencies frequently require a Medicon WC (written confirmation) as part of the regulatory process.
click here to find a list of Medicon 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 Medicon as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Medicon 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 Medicon 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 Medicon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Medicon NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Medicon suppliers with NDC on PharmaCompass.
Medicon 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 Medicon 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 Medicon GMP manufacturer or Medicon GMP API supplier for your needs.
A Medicon CoA (Certificate of Analysis) is a formal document that attests to Medicon's compliance with Medicon specifications and serves as a tool for batch-level quality control.
Medicon CoA mostly includes findings from lab analyses of a specific batch. For each Medicon 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.
Medicon may be tested according to a variety of international standards, such as European Pharmacopoeia (Medicon EP), Medicon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Medicon USP).
