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ABOUT THIS PAGE
A Benidipine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benidipine Hydrochloride, including repackagers and relabelers. The FDA regulates Benidipine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benidipine 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 Benidipine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benidipine Hydrochloride supplier is an individual or a company that provides Benidipine Hydrochloride active pharmaceutical ingredient (API) or Benidipine Hydrochloride finished formulations upon request. The Benidipine Hydrochloride suppliers may include Benidipine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Benidipine 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 Benidipine Hydrochloride Drug Master File in Japan (Benidipine Hydrochloride JDMF) empowers Benidipine 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 Benidipine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Benidipine 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 Benidipine 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 Benidipine Hydrochloride Drug Master File in Korea (Benidipine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Benidipine Hydrochloride. The MFDS reviews the Benidipine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Benidipine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Benidipine 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 Benidipine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Benidipine Hydrochloride suppliers with KDMF on PharmaCompass.
Benidipine 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 Benidipine 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 Benidipine Hydrochloride GMP manufacturer or Benidipine Hydrochloride GMP API supplier for your needs.
A Benidipine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Benidipine Hydrochloride's compliance with Benidipine Hydrochloride specifications and serves as a tool for batch-level quality control.
Benidipine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Benidipine 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.
Benidipine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Benidipine Hydrochloride EP), Benidipine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benidipine Hydrochloride USP).
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