Synopsis
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USDMF
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CEP/COS
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EU WC
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NDC API
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VMF
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API
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FDF
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FDA Orange Book
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Europe
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Canada
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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News #PharmaBuzz
US Medicaid
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Global Sales Information
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Sarpogrelate Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sarpogrelate Hydrochloride, including repackagers and relabelers. The FDA regulates Sarpogrelate Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sarpogrelate 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 Sarpogrelate Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sarpogrelate Hydrochloride supplier is an individual or a company that provides Sarpogrelate Hydrochloride active pharmaceutical ingredient (API) or Sarpogrelate Hydrochloride finished formulations upon request. The Sarpogrelate Hydrochloride suppliers may include Sarpogrelate Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sarpogrelate 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 Sarpogrelate Hydrochloride Drug Master File in Japan (Sarpogrelate Hydrochloride JDMF) empowers Sarpogrelate 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 Sarpogrelate Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Sarpogrelate 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 Sarpogrelate 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 Sarpogrelate Hydrochloride Drug Master File in Korea (Sarpogrelate Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sarpogrelate Hydrochloride. The MFDS reviews the Sarpogrelate Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Sarpogrelate Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sarpogrelate 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 Sarpogrelate Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sarpogrelate Hydrochloride suppliers with KDMF on PharmaCompass.
Sarpogrelate 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 Sarpogrelate 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 Sarpogrelate Hydrochloride GMP manufacturer or Sarpogrelate Hydrochloride GMP API supplier for your needs.
A Sarpogrelate Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Sarpogrelate Hydrochloride's compliance with Sarpogrelate Hydrochloride specifications and serves as a tool for batch-level quality control.
Sarpogrelate Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Sarpogrelate 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.
Sarpogrelate Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Sarpogrelate Hydrochloride EP), Sarpogrelate Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sarpogrelate Hydrochloride USP).
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