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PharmaCompass offers a list of Benidipine 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 Benidipine Hydrochloride manufacturer or Benidipine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benidipine Hydrochloride manufacturer or Benidipine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Benidipine Hydrochloride API Price utilized in the formulation of products. Benidipine Hydrochloride API Price is not always fixed or binding as the Benidipine Hydrochloride Price is obtained through a variety of data sources. The Benidipine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A BENIDIPINE HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BENIDIPINE HCl, including repackagers and relabelers. The FDA regulates BENIDIPINE HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BENIDIPINE HCl 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 HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A BENIDIPINE HCl supplier is an individual or a company that provides BENIDIPINE HCl active pharmaceutical ingredient (API) or BENIDIPINE HCl finished formulations upon request. The BENIDIPINE HCl suppliers may include BENIDIPINE HCl API manufacturers, exporters, distributors and traders.
click here to find a list of BENIDIPINE HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A BENIDIPINE HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of BENIDIPINE HCl active pharmaceutical ingredient (API) in detail. Different forms of BENIDIPINE HCl DMFs exist exist since differing nations have different regulations, such as BENIDIPINE HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BENIDIPINE HCl DMF submitted to regulatory agencies in the US is known as a USDMF. BENIDIPINE HCl USDMF includes data on BENIDIPINE HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BENIDIPINE HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of BENIDIPINE HCl 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 BENIDIPINE HCl Drug Master File in Japan (BENIDIPINE HCl JDMF) empowers BENIDIPINE HCl 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 HCl JDMF during the approval evaluation for pharmaceutical products. At the time of BENIDIPINE HCl 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 HCl 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 HCl Drug Master File in Korea (BENIDIPINE HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of BENIDIPINE HCl. The MFDS reviews the BENIDIPINE HCl KDMF as part of the drug registration process and uses the information provided in the BENIDIPINE HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a BENIDIPINE HCl 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 HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of BENIDIPINE HCl suppliers with KDMF on PharmaCompass.
BENIDIPINE HCl 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 HCl 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 HCl GMP manufacturer or BENIDIPINE HCl GMP API supplier for your needs.
A BENIDIPINE HCl CoA (Certificate of Analysis) is a formal document that attests to BENIDIPINE HCl's compliance with BENIDIPINE HCl specifications and serves as a tool for batch-level quality control.
BENIDIPINE HCl CoA mostly includes findings from lab analyses of a specific batch. For each BENIDIPINE HCl 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 HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (BENIDIPINE HCl EP), BENIDIPINE HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BENIDIPINE HCl USP).
