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