Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 25MG;25MG
USFDA APPLICATION NUMBER - 12616
DOSAGE - TABLET;ORAL - 50MG;50MG
USFDA APPLICATION NUMBER - 12616
DOSAGE - CAPSULE;ORAL - 25MG;37.5MG **Federal...DOSAGE - CAPSULE;ORAL - 25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 16042
DOSAGE - TABLET;ORAL - 25MG;37.5MG
USFDA APPLICATION NUMBER - 19129
DOSAGE - TABLET;ORAL - 50MG;75MG
USFDA APPLICATION NUMBER - 19129
DOSAGE - TABLET;ORAL - 10MG;25MG
USFDA APPLICATION NUMBER - 19221
DOSAGE - TABLET;ORAL - 5MG;12.5MG
USFDA APPLICATION NUMBER - 19221
DOSAGE - TABLET;ORAL - 12.5MG;10MG
USFDA APPLICATION NUMBER - 19888
DOSAGE - TABLET;ORAL - 12.5MG;20MG
USFDA APPLICATION NUMBER - 19888
DOSAGE - TABLET;ORAL - 25MG;20MG
USFDA APPLICATION NUMBER - 19888
DOSAGE - TABLET;ORAL - 12.5MG;100MG
USFDA APPLICATION NUMBER - 20387
DOSAGE - TABLET;ORAL - 12.5MG;50MG
USFDA APPLICATION NUMBER - 20387
DOSAGE - TABLET;ORAL - 25MG;100MG
USFDA APPLICATION NUMBER - 20387
DOSAGE - CAPSULE;ORAL - 12.5MG
USFDA APPLICATION NUMBER - 20504
DOSAGE - TABLET;ORAL - 12.5MG;150MG
USFDA APPLICATION NUMBER - 20758
DOSAGE - TABLET;ORAL - 12.5MG;300MG
USFDA APPLICATION NUMBER - 20758
DOSAGE - TABLET;ORAL - 12.5MG;75MG **Federal ...DOSAGE - TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20758
DOSAGE - TABLET;ORAL - 25MG;300MG **Federal R...DOSAGE - TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20758
DOSAGE - TABLET;ORAL - 12.5MG;160MG
USFDA APPLICATION NUMBER - 20818
DOSAGE - TABLET;ORAL - 12.5MG;320MG
USFDA APPLICATION NUMBER - 20818
DOSAGE - TABLET;ORAL - 12.5MG;80MG
USFDA APPLICATION NUMBER - 20818
DOSAGE - TABLET;ORAL - 25MG;160MG
USFDA APPLICATION NUMBER - 20818
DOSAGE - TABLET;ORAL - 25MG;320MG
USFDA APPLICATION NUMBER - 20818
DOSAGE - TABLET;ORAL - 16MG;12.5MG
USFDA APPLICATION NUMBER - 21093
DOSAGE - TABLET;ORAL - 32MG;12.5MG
USFDA APPLICATION NUMBER - 21093
DOSAGE - TABLET;ORAL - 32MG;25MG
USFDA APPLICATION NUMBER - 21093
DOSAGE - TABLET;ORAL - 12.5MG;40MG
USFDA APPLICATION NUMBER - 21162
DOSAGE - TABLET;ORAL - 12.5MG;80MG
USFDA APPLICATION NUMBER - 21162
DOSAGE - TABLET;ORAL - 25MG;80MG
USFDA APPLICATION NUMBER - 21162
DOSAGE - TABLET;ORAL - 12.5MG;20MG
USFDA APPLICATION NUMBER - 21532
DOSAGE - TABLET;ORAL - 12.5MG;40MG
USFDA APPLICATION NUMBER - 21532
DOSAGE - TABLET;ORAL - 25MG;40MG
USFDA APPLICATION NUMBER - 21532
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21956
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21956
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21956
DOSAGE - TABLET;ORAL - EQ 150MG BASE;12.5MG *...DOSAGE - TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22107
DOSAGE - TABLET;ORAL - EQ 150MG BASE;25MG **F...DOSAGE - TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22107
DOSAGE - TABLET;ORAL - EQ 300MG BASE;12.5MG *...DOSAGE - TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22107
DOSAGE - TABLET;ORAL - EQ 300MG BASE;25MG **F...DOSAGE - TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22107
DOSAGE - TABLET;ORAL - EQ 10MG BASE;12.5MG;16...DOSAGE - TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG
USFDA APPLICATION NUMBER - 22314
DOSAGE - TABLET;ORAL - EQ 10MG BASE;25MG;160M...DOSAGE - TABLET;ORAL - EQ 10MG BASE;25MG;160MG
USFDA APPLICATION NUMBER - 22314
DOSAGE - TABLET;ORAL - EQ 10MG BASE;25MG;320M...DOSAGE - TABLET;ORAL - EQ 10MG BASE;25MG;320MG
USFDA APPLICATION NUMBER - 22314
DOSAGE - TABLET;ORAL - EQ 5MG BASE;12.5MG;160...DOSAGE - TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG
USFDA APPLICATION NUMBER - 22314
DOSAGE - TABLET;ORAL - EQ 5MG BASE;25MG;160MG
USFDA APPLICATION NUMBER - 22314
DOSAGE - TABLET;ORAL - 12.5MG
USFDA APPLICATION NUMBER - 83177
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 83177
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 83177
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Minakem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Minbiotech
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Panvo Organics
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Cerata Pharmaceuticals LLP
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Avesta Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Doshion Polyscience
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gloria Interchem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Huzhou Sunflower Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JJ Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Symrise
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vertellus
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Direct Compression
Disintegrants & Superdisintegrants
Granulation
Solubilizers
Lubricants & Glidants
Thickeners and Stabilizers
Topical
Parenteral
Film Formers & Plasticizers
Controlled & Modified Release
Taste Masking
Chewable & Orodispersible Aids
Co-Processed Excipients
Emulsifying Agents
API Stability Enhancers
Surfactant & Foaming Agents
Empty Capsules
Rheology Modifiers
Vegetarian Capsules
Coloring Agents
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
77
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 Direma manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Direma, including repackagers and relabelers. The FDA regulates Direma manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Direma 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 Direma manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Direma supplier is an individual or a company that provides Direma active pharmaceutical ingredient (API) or Direma finished formulations upon request. The Direma suppliers may include Direma API manufacturers, exporters, distributors and traders.
click here to find a list of Direma suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Direma DMF (Drug Master File) is a document detailing the whole manufacturing process of Direma active pharmaceutical ingredient (API) in detail. Different forms of Direma DMFs exist exist since differing nations have different regulations, such as Direma USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Direma DMF submitted to regulatory agencies in the US is known as a USDMF. Direma USDMF includes data on Direma's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Direma USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Direma 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 Direma Drug Master File in Japan (Direma JDMF) empowers Direma 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 Direma JDMF during the approval evaluation for pharmaceutical products. At the time of Direma 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 Direma 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 Direma Drug Master File in Korea (Direma KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Direma. The MFDS reviews the Direma KDMF as part of the drug registration process and uses the information provided in the Direma KDMF to evaluate the safety and efficacy of the drug.
After submitting a Direma 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 Direma API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Direma suppliers with KDMF on PharmaCompass.
A Direma CEP of the European Pharmacopoeia monograph is often referred to as a Direma Certificate of Suitability (COS). The purpose of a Direma CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Direma EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Direma to their clients by showing that a Direma CEP has been issued for it. The manufacturer submits a Direma CEP (COS) as part of the market authorization procedure, and it takes on the role of a Direma CEP holder for the record. Additionally, the data presented in the Direma CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Direma DMF.
A Direma CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Direma 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 Direma suppliers with CEP (COS) on PharmaCompass.
A Direma written confirmation (Direma WC) is an official document issued by a regulatory agency to a Direma manufacturer, verifying that the manufacturing facility of a Direma active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Direma APIs or Direma finished pharmaceutical products to another nation, regulatory agencies frequently require a Direma WC (written confirmation) as part of the regulatory process.
click here to find a list of Direma 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 Direma as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Direma 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 Direma 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 Direma and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Direma NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Direma suppliers with NDC on PharmaCompass.
Direma 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 Direma 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 Direma GMP manufacturer or Direma GMP API supplier for your needs.
A Direma CoA (Certificate of Analysis) is a formal document that attests to Direma's compliance with Direma specifications and serves as a tool for batch-level quality control.
Direma CoA mostly includes findings from lab analyses of a specific batch. For each Direma 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.
Direma may be tested according to a variety of international standards, such as European Pharmacopoeia (Direma EP), Direma JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Direma USP).
