X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
24
PharmaCompass offers a list of Hydrochlorothiazide 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 Hydrochlorothiazide manufacturer or Hydrochlorothiazide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydrochlorothiazide manufacturer or Hydrochlorothiazide supplier.
PharmaCompass also assists you with knowing the Hydrochlorothiazide API Price utilized in the formulation of products. Hydrochlorothiazide API Price is not always fixed or binding as the Hydrochlorothiazide Price is obtained through a variety of data sources. The Hydrochlorothiazide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Acesistem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acesistem, including repackagers and relabelers. The FDA regulates Acesistem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acesistem 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 Acesistem manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acesistem supplier is an individual or a company that provides Acesistem active pharmaceutical ingredient (API) or Acesistem finished formulations upon request. The Acesistem suppliers may include Acesistem API manufacturers, exporters, distributors and traders.
click here to find a list of Acesistem suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acesistem DMF (Drug Master File) is a document detailing the whole manufacturing process of Acesistem active pharmaceutical ingredient (API) in detail. Different forms of Acesistem DMFs exist exist since differing nations have different regulations, such as Acesistem USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acesistem DMF submitted to regulatory agencies in the US is known as a USDMF. Acesistem USDMF includes data on Acesistem's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acesistem USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acesistem 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 Acesistem Drug Master File in Japan (Acesistem JDMF) empowers Acesistem 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 Acesistem JDMF during the approval evaluation for pharmaceutical products. At the time of Acesistem 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 Acesistem 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 Acesistem Drug Master File in Korea (Acesistem KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Acesistem. The MFDS reviews the Acesistem KDMF as part of the drug registration process and uses the information provided in the Acesistem KDMF to evaluate the safety and efficacy of the drug.
After submitting a Acesistem 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 Acesistem API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Acesistem suppliers with KDMF on PharmaCompass.
A Acesistem CEP of the European Pharmacopoeia monograph is often referred to as a Acesistem Certificate of Suitability (COS). The purpose of a Acesistem CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Acesistem EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Acesistem to their clients by showing that a Acesistem CEP has been issued for it. The manufacturer submits a Acesistem CEP (COS) as part of the market authorization procedure, and it takes on the role of a Acesistem CEP holder for the record. Additionally, the data presented in the Acesistem CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Acesistem DMF.
A Acesistem CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Acesistem 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 Acesistem suppliers with CEP (COS) on PharmaCompass.
A Acesistem written confirmation (Acesistem WC) is an official document issued by a regulatory agency to a Acesistem manufacturer, verifying that the manufacturing facility of a Acesistem active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Acesistem APIs or Acesistem finished pharmaceutical products to another nation, regulatory agencies frequently require a Acesistem WC (written confirmation) as part of the regulatory process.
click here to find a list of Acesistem 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 Acesistem as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Acesistem 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 Acesistem 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 Acesistem and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acesistem NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Acesistem suppliers with NDC on PharmaCompass.
Acesistem 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 Acesistem 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 Acesistem GMP manufacturer or Acesistem GMP API supplier for your needs.
A Acesistem CoA (Certificate of Analysis) is a formal document that attests to Acesistem's compliance with Acesistem specifications and serves as a tool for batch-level quality control.
Acesistem CoA mostly includes findings from lab analyses of a specific batch. For each Acesistem 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.
Acesistem may be tested according to a variety of international standards, such as European Pharmacopoeia (Acesistem EP), Acesistem JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acesistem USP).
Market Place
