X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
87
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 Altiazem Retard manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Altiazem Retard, including repackagers and relabelers. The FDA regulates Altiazem Retard manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Altiazem Retard 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 Altiazem Retard manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Altiazem Retard supplier is an individual or a company that provides Altiazem Retard active pharmaceutical ingredient (API) or Altiazem Retard finished formulations upon request. The Altiazem Retard suppliers may include Altiazem Retard API manufacturers, exporters, distributors and traders.
click here to find a list of Altiazem Retard suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Altiazem Retard DMF (Drug Master File) is a document detailing the whole manufacturing process of Altiazem Retard active pharmaceutical ingredient (API) in detail. Different forms of Altiazem Retard DMFs exist exist since differing nations have different regulations, such as Altiazem Retard USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Altiazem Retard DMF submitted to regulatory agencies in the US is known as a USDMF. Altiazem Retard USDMF includes data on Altiazem Retard's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Altiazem Retard USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Altiazem Retard 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 Altiazem Retard Drug Master File in Japan (Altiazem Retard JDMF) empowers Altiazem Retard 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 Altiazem Retard JDMF during the approval evaluation for pharmaceutical products. At the time of Altiazem Retard 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 Altiazem Retard 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 Altiazem Retard Drug Master File in Korea (Altiazem Retard KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Altiazem Retard. The MFDS reviews the Altiazem Retard KDMF as part of the drug registration process and uses the information provided in the Altiazem Retard KDMF to evaluate the safety and efficacy of the drug.
After submitting a Altiazem Retard 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 Altiazem Retard API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Altiazem Retard suppliers with KDMF on PharmaCompass.
A Altiazem Retard CEP of the European Pharmacopoeia monograph is often referred to as a Altiazem Retard Certificate of Suitability (COS). The purpose of a Altiazem Retard CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Altiazem Retard EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Altiazem Retard to their clients by showing that a Altiazem Retard CEP has been issued for it. The manufacturer submits a Altiazem Retard CEP (COS) as part of the market authorization procedure, and it takes on the role of a Altiazem Retard CEP holder for the record. Additionally, the data presented in the Altiazem Retard CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Altiazem Retard DMF.
A Altiazem Retard CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Altiazem Retard 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 Altiazem Retard suppliers with CEP (COS) on PharmaCompass.
A Altiazem Retard written confirmation (Altiazem Retard WC) is an official document issued by a regulatory agency to a Altiazem Retard manufacturer, verifying that the manufacturing facility of a Altiazem Retard active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Altiazem Retard APIs or Altiazem Retard finished pharmaceutical products to another nation, regulatory agencies frequently require a Altiazem Retard WC (written confirmation) as part of the regulatory process.
click here to find a list of Altiazem Retard 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 Altiazem Retard as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Altiazem Retard 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 Altiazem Retard 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 Altiazem Retard and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Altiazem Retard NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Altiazem Retard suppliers with NDC on PharmaCompass.
Altiazem Retard 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 Altiazem Retard 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 Altiazem Retard GMP manufacturer or Altiazem Retard GMP API supplier for your needs.
A Altiazem Retard CoA (Certificate of Analysis) is a formal document that attests to Altiazem Retard's compliance with Altiazem Retard specifications and serves as a tool for batch-level quality control.
Altiazem Retard CoA mostly includes findings from lab analyses of a specific batch. For each Altiazem Retard 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.
Altiazem Retard may be tested according to a variety of international standards, such as European Pharmacopoeia (Altiazem Retard EP), Altiazem Retard JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Altiazem Retard USP).
Market Place
