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PharmaCompass offers a list of Milnacipran Hydrochloride 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 Milnacipran Hydrochloride manufacturer or Milnacipran Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Milnacipran Hydrochloride manufacturer or Milnacipran Hydrochloride supplier.
PharmaCompass also assists you with knowing the Milnacipran Hydrochloride API Price utilized in the formulation of products. Milnacipran Hydrochloride API Price is not always fixed or binding as the Milnacipran Hydrochloride Price is obtained through a variety of data sources. The Milnacipran Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Milnacipran Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Milnacipran Hydrochloride, including repackagers and relabelers. The FDA regulates Milnacipran Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Milnacipran 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 Milnacipran Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Milnacipran Hydrochloride supplier is an individual or a company that provides Milnacipran Hydrochloride active pharmaceutical ingredient (API) or Milnacipran Hydrochloride finished formulations upon request. The Milnacipran Hydrochloride suppliers may include Milnacipran Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Milnacipran Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Milnacipran Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Milnacipran Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Milnacipran Hydrochloride DMFs exist exist since differing nations have different regulations, such as Milnacipran Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Milnacipran Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Milnacipran Hydrochloride USDMF includes data on Milnacipran Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Milnacipran Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Milnacipran Hydrochloride 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 Milnacipran Hydrochloride Drug Master File in Japan (Milnacipran Hydrochloride JDMF) empowers Milnacipran Hydrochloride 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 Milnacipran Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Milnacipran Hydrochloride 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 Milnacipran Hydrochloride 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 Milnacipran Hydrochloride Drug Master File in Korea (Milnacipran Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Milnacipran Hydrochloride. The MFDS reviews the Milnacipran Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Milnacipran Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Milnacipran Hydrochloride 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 Milnacipran Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Milnacipran Hydrochloride suppliers with KDMF on PharmaCompass.
A Milnacipran Hydrochloride written confirmation (Milnacipran Hydrochloride WC) is an official document issued by a regulatory agency to a Milnacipran Hydrochloride manufacturer, verifying that the manufacturing facility of a Milnacipran Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Milnacipran Hydrochloride APIs or Milnacipran Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Milnacipran Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Milnacipran 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 Milnacipran Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Milnacipran 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 Milnacipran 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 Milnacipran Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Milnacipran Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Milnacipran Hydrochloride suppliers with NDC on PharmaCompass.
Milnacipran 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 Milnacipran Hydrochloride 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 Hydrochloride GMP manufacturer or Milnacipran Hydrochloride GMP API supplier for your needs.
A Milnacipran Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Milnacipran Hydrochloride's compliance with Milnacipran Hydrochloride specifications and serves as a tool for batch-level quality control.
Milnacipran Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Milnacipran 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.
Milnacipran Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Milnacipran Hydrochloride EP), Milnacipran Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Milnacipran Hydrochloride USP).
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