Synopsis
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CEP/COS
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JDMF
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KDMF
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VMF
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FDF
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Europe
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS0
EDQM
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USP
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JP
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Others
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API SUPPLIERS
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USDMF
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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 120MG BASE
USFDA APPLICATION NUMBER - 204168
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 204168
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 40MG BASE
USFDA APPLICATION NUMBER - 204168
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 80MG BASE
USFDA APPLICATION NUMBER - 204168
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ABOUT THIS PAGE
A Milnacipran HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Milnacipran HCl, including repackagers and relabelers. The FDA regulates Milnacipran HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Milnacipran HCl 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 Milnacipran HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Milnacipran HCl supplier is an individual or a company that provides Milnacipran HCl active pharmaceutical ingredient (API) or Milnacipran HCl finished formulations upon request. The Milnacipran HCl suppliers may include Milnacipran HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Milnacipran HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Milnacipran HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Milnacipran HCl active pharmaceutical ingredient (API) in detail. Different forms of Milnacipran HCl DMFs exist exist since differing nations have different regulations, such as Milnacipran HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Milnacipran HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Milnacipran HCl USDMF includes data on Milnacipran HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Milnacipran HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Milnacipran HCl suppliers with USDMF on PharmaCompass.
A Milnacipran HCl written confirmation (Milnacipran HCl WC) is an official document issued by a regulatory agency to a Milnacipran HCl manufacturer, verifying that the manufacturing facility of a Milnacipran HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Milnacipran HCl APIs or Milnacipran HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Milnacipran HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Milnacipran HCl 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 Milnacipran HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Milnacipran HCl 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 Milnacipran HCl 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 Milnacipran HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Milnacipran HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Milnacipran HCl suppliers with NDC on PharmaCompass.
Milnacipran HCl 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 Milnacipran HCl 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 Milnacipran HCl GMP manufacturer or Milnacipran HCl GMP API supplier for your needs.
A Milnacipran HCl CoA (Certificate of Analysis) is a formal document that attests to Milnacipran HCl's compliance with Milnacipran HCl specifications and serves as a tool for batch-level quality control.
Milnacipran HCl CoA mostly includes findings from lab analyses of a specific batch. For each Milnacipran HCl 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.
Milnacipran HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Milnacipran HCl EP), Milnacipran HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Milnacipran HCl USP).
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