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DRUG PRODUCT COMPOSITIONS0
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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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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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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 Demorphan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Demorphan, including repackagers and relabelers. The FDA regulates Demorphan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Demorphan 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 Demorphan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Demorphan supplier is an individual or a company that provides Demorphan active pharmaceutical ingredient (API) or Demorphan finished formulations upon request. The Demorphan suppliers may include Demorphan API manufacturers, exporters, distributors and traders.
click here to find a list of Demorphan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Demorphan DMF (Drug Master File) is a document detailing the whole manufacturing process of Demorphan active pharmaceutical ingredient (API) in detail. Different forms of Demorphan DMFs exist exist since differing nations have different regulations, such as Demorphan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Demorphan DMF submitted to regulatory agencies in the US is known as a USDMF. Demorphan USDMF includes data on Demorphan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Demorphan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Demorphan 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 Demorphan Drug Master File in Japan (Demorphan JDMF) empowers Demorphan 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 Demorphan JDMF during the approval evaluation for pharmaceutical products. At the time of Demorphan 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 Demorphan 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 Demorphan Drug Master File in Korea (Demorphan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Demorphan. The MFDS reviews the Demorphan KDMF as part of the drug registration process and uses the information provided in the Demorphan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Demorphan 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 Demorphan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Demorphan suppliers with KDMF on PharmaCompass.
A Demorphan CEP of the European Pharmacopoeia monograph is often referred to as a Demorphan Certificate of Suitability (COS). The purpose of a Demorphan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Demorphan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Demorphan to their clients by showing that a Demorphan CEP has been issued for it. The manufacturer submits a Demorphan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Demorphan CEP holder for the record. Additionally, the data presented in the Demorphan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Demorphan DMF.
A Demorphan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Demorphan 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 Demorphan suppliers with CEP (COS) on PharmaCompass.
A Demorphan written confirmation (Demorphan WC) is an official document issued by a regulatory agency to a Demorphan manufacturer, verifying that the manufacturing facility of a Demorphan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Demorphan APIs or Demorphan finished pharmaceutical products to another nation, regulatory agencies frequently require a Demorphan WC (written confirmation) as part of the regulatory process.
click here to find a list of Demorphan 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 Demorphan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Demorphan 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 Demorphan 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 Demorphan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Demorphan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Demorphan suppliers with NDC on PharmaCompass.
Demorphan 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 Demorphan 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 Demorphan GMP manufacturer or Demorphan GMP API supplier for your needs.
A Demorphan CoA (Certificate of Analysis) is a formal document that attests to Demorphan's compliance with Demorphan specifications and serves as a tool for batch-level quality control.
Demorphan CoA mostly includes findings from lab analyses of a specific batch. For each Demorphan 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.
Demorphan may be tested according to a variety of international standards, such as European Pharmacopoeia (Demorphan EP), Demorphan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Demorphan USP).
