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PharmaCompass offers a list of Eperisone 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 Eperisone Hydrochloride manufacturer or Eperisone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Eperisone Hydrochloride manufacturer or Eperisone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Eperisone Hydrochloride API Price utilized in the formulation of products. Eperisone Hydrochloride API Price is not always fixed or binding as the Eperisone Hydrochloride Price is obtained through a variety of data sources. The Eperisone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Eperisone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eperisone Hydrochloride, including repackagers and relabelers. The FDA regulates Eperisone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eperisone 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 Eperisone Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eperisone Hydrochloride supplier is an individual or a company that provides Eperisone Hydrochloride active pharmaceutical ingredient (API) or Eperisone Hydrochloride finished formulations upon request. The Eperisone Hydrochloride suppliers may include Eperisone Hydrochloride API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Eperisone Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Eperisone Hydrochloride Drug Master File in Japan (Eperisone Hydrochloride JDMF) empowers Eperisone 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 Eperisone Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Eperisone Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Eperisone Hydrochloride Drug Master File in Korea (Eperisone Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eperisone Hydrochloride. The MFDS reviews the Eperisone Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Eperisone Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eperisone 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 Eperisone Hydrochloride API can apply through the Korea Drug Master File (KDMF).
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A Eperisone Hydrochloride written confirmation (Eperisone Hydrochloride WC) is an official document issued by a regulatory agency to a Eperisone Hydrochloride manufacturer, verifying that the manufacturing facility of a Eperisone Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eperisone Hydrochloride APIs or Eperisone Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Eperisone Hydrochloride WC (written confirmation) as part of the regulatory process.
CLICK HERE to find a list of Eperisone Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
Eperisone 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 Eperisone 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 Eperisone Hydrochloride GMP manufacturer or Eperisone Hydrochloride GMP API supplier for your needs.
A Eperisone Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Eperisone Hydrochloride's compliance with Eperisone Hydrochloride specifications and serves as a tool for batch-level quality control.
Eperisone Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Eperisone 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.
Eperisone Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Eperisone Hydrochloride EP), Eperisone Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eperisone Hydrochloride USP).