X
API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
0
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
83
PharmaCompass offers a list of Pilsicainide 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 Pilsicainide Hydrochloride manufacturer or Pilsicainide Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pilsicainide Hydrochloride manufacturer or Pilsicainide Hydrochloride supplier.
PharmaCompass also assists you with knowing the Pilsicainide Hydrochloride API Price utilized in the formulation of products. Pilsicainide Hydrochloride API Price is not always fixed or binding as the Pilsicainide Hydrochloride Price is obtained through a variety of data sources. The Pilsicainide Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 03C8I9296V manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 03C8I9296V, including repackagers and relabelers. The FDA regulates 03C8I9296V manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 03C8I9296V 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 03C8I9296V manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 03C8I9296V supplier is an individual or a company that provides 03C8I9296V active pharmaceutical ingredient (API) or 03C8I9296V finished formulations upon request. The 03C8I9296V suppliers may include 03C8I9296V API manufacturers, exporters, distributors and traders.
click here to find a list of 03C8I9296V 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 03C8I9296V Drug Master File in Japan (03C8I9296V JDMF) empowers 03C8I9296V 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 03C8I9296V JDMF during the approval evaluation for pharmaceutical products. At the time of 03C8I9296V 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 03C8I9296V 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 03C8I9296V Drug Master File in Korea (03C8I9296V KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 03C8I9296V. The MFDS reviews the 03C8I9296V KDMF as part of the drug registration process and uses the information provided in the 03C8I9296V KDMF to evaluate the safety and efficacy of the drug.
After submitting a 03C8I9296V 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 03C8I9296V API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 03C8I9296V suppliers with KDMF on PharmaCompass.
03C8I9296V 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 03C8I9296V 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 03C8I9296V GMP manufacturer or 03C8I9296V GMP API supplier for your needs.
A 03C8I9296V CoA (Certificate of Analysis) is a formal document that attests to 03C8I9296V's compliance with 03C8I9296V specifications and serves as a tool for batch-level quality control.
03C8I9296V CoA mostly includes findings from lab analyses of a specific batch. For each 03C8I9296V 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.
03C8I9296V may be tested according to a variety of international standards, such as European Pharmacopoeia (03C8I9296V EP), 03C8I9296V JP (Japanese Pharmacopeia) and the US Pharmacopoeia (03C8I9296V USP).
Market Place
