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