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