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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37321
Submission : 2022-07-28
Status :
Type : II
Maithri Drugs: Dedicated to your API needs.
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-09
Pay. Date : 2021-05-05
DMF Number : 34897
Submission : 2020-05-30
Status :
Type : II
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Maithri Drugs: Dedicated to your API needs.
Date of Issue : 2024-02-12
Valid Till : 2027-02-11
Written Confirmation Number : WC-0407
Address of the Firm : Sy. No. 205, 222 to 226, IDA Bonthapally, Bonthapally (Village), Gummadidala (Ma...
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
Maithri Drugs: Dedicated to your API needs.
About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Fenfluramine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Fenfluramine Hydrochloride manufacturer or Fenfluramine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fenfluramine Hydrochloride manufacturer or Fenfluramine Hydrochloride supplier.
A Fenfluramine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fenfluramine Hydrochloride, including repackagers and relabelers. The FDA regulates Fenfluramine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fenfluramine 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 Fenfluramine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Fenfluramine Hydrochloride supplier is an individual or a company that provides Fenfluramine Hydrochloride active pharmaceutical ingredient (API) or Fenfluramine Hydrochloride finished formulations upon request. The Fenfluramine Hydrochloride suppliers may include Fenfluramine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Fenfluramine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Fenfluramine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Fenfluramine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Fenfluramine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Fenfluramine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fenfluramine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Fenfluramine Hydrochloride USDMF includes data on Fenfluramine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fenfluramine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fenfluramine Hydrochloride suppliers with USDMF on PharmaCompass.
A Fenfluramine Hydrochloride written confirmation (Fenfluramine Hydrochloride WC) is an official document issued by a regulatory agency to a Fenfluramine Hydrochloride manufacturer, verifying that the manufacturing facility of a Fenfluramine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fenfluramine Hydrochloride APIs or Fenfluramine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Fenfluramine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Fenfluramine 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 Fenfluramine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fenfluramine 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 Fenfluramine 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 Fenfluramine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fenfluramine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fenfluramine Hydrochloride suppliers with NDC on PharmaCompass.
Fenfluramine 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 Fenfluramine Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Fenfluramine Hydrochloride GMP manufacturer or Fenfluramine Hydrochloride GMP API supplier for your needs.
A Fenfluramine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Fenfluramine Hydrochloride's compliance with Fenfluramine Hydrochloride specifications and serves as a tool for batch-level quality control.
Fenfluramine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Fenfluramine 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.
Fenfluramine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Fenfluramine Hydrochloride EP), Fenfluramine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fenfluramine Hydrochloride USP).
