Synopsis
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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
FDF
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Stock Recap #PipelineProspector
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API SUPPLIERS
Jai Radhe Sales is your partner for all your sourcing needs.
With Virupaksha, you get a quality product with on-time delivery.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
NDC 
Maithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.
EU-WC
ASMF, CN...
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USDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5104
Submission : 1983-07-25
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-10
Pay. Date : 2021-04-22
DMF Number : 35236
Submission : 2021-08-31
Status :
Type : II
Maithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-09
Pay. Date : 2018-08-03
DMF Number : 32641
Submission : 2018-03-30
Status :
Type : II
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DOSAGE - TABLET;ORAL - 100MG;25MG
USFDA APPLICATION NUMBER - 18760
DOSAGE - TABLET;ORAL - 50MG;25MG
USFDA APPLICATION NUMBER - 18760
DOSAGE - TABLET;ORAL - 15MG
USFDA APPLICATION NUMBER - 19574
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 19574
DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL;12.5...DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL;12.5MG
USFDA APPLICATION NUMBER - 202331
DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL;25MG
USFDA APPLICATION NUMBER - 202331
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 86831
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 86831
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Coating Systems & Additives
Disintegrants & Superdisintegrants
Direct Compression
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
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SPI Pharma has been solving formulation challenges using superior functional materials.
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Brand Name : Mannogem Granular
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Excipient Details : Mannogem Granular has larger particles, offering a softer texture for chewable tablets and excellent flow, disintegration, and compression properties.
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Dosage Form : Orodispersible Tablet, Tablet
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Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170 µm, Tapped Density: 0.80
Ingredient(s) : Magnesium Hydroxide Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
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Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
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Lubricants & Glidants
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ABOUT THIS PAGE
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PharmaCompass offers a list of Chlorthalidone 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 Chlorthalidone manufacturer or Chlorthalidone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Chlorthalidone manufacturer or Chlorthalidone supplier.
PharmaCompass also assists you with knowing the Chlorthalidone API Price utilized in the formulation of products. Chlorthalidone API Price is not always fixed or binding as the Chlorthalidone Price is obtained through a variety of data sources. The Chlorthalidone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Chlorthalidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlorthalidone, including repackagers and relabelers. The FDA regulates Chlorthalidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlorthalidone 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 Chlorthalidone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chlorthalidone supplier is an individual or a company that provides Chlorthalidone active pharmaceutical ingredient (API) or Chlorthalidone finished formulations upon request. The Chlorthalidone suppliers may include Chlorthalidone API manufacturers, exporters, distributors and traders.
click here to find a list of Chlorthalidone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chlorthalidone DMF (Drug Master File) is a document detailing the whole manufacturing process of Chlorthalidone active pharmaceutical ingredient (API) in detail. Different forms of Chlorthalidone DMFs exist exist since differing nations have different regulations, such as Chlorthalidone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chlorthalidone DMF submitted to regulatory agencies in the US is known as a USDMF. Chlorthalidone USDMF includes data on Chlorthalidone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chlorthalidone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chlorthalidone suppliers with USDMF 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 Chlorthalidone Drug Master File in Korea (Chlorthalidone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Chlorthalidone. The MFDS reviews the Chlorthalidone KDMF as part of the drug registration process and uses the information provided in the Chlorthalidone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Chlorthalidone 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 Chlorthalidone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Chlorthalidone suppliers with KDMF on PharmaCompass.
A Chlorthalidone CEP of the European Pharmacopoeia monograph is often referred to as a Chlorthalidone Certificate of Suitability (COS). The purpose of a Chlorthalidone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Chlorthalidone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Chlorthalidone to their clients by showing that a Chlorthalidone CEP has been issued for it. The manufacturer submits a Chlorthalidone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Chlorthalidone CEP holder for the record. Additionally, the data presented in the Chlorthalidone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Chlorthalidone DMF.
A Chlorthalidone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Chlorthalidone 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 Chlorthalidone suppliers with CEP (COS) on PharmaCompass.
A Chlorthalidone written confirmation (Chlorthalidone WC) is an official document issued by a regulatory agency to a Chlorthalidone manufacturer, verifying that the manufacturing facility of a Chlorthalidone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Chlorthalidone APIs or Chlorthalidone finished pharmaceutical products to another nation, regulatory agencies frequently require a Chlorthalidone WC (written confirmation) as part of the regulatory process.
click here to find a list of Chlorthalidone 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 Chlorthalidone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Chlorthalidone 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 Chlorthalidone 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 Chlorthalidone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Chlorthalidone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Chlorthalidone suppliers with NDC on PharmaCompass.
Chlorthalidone 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 Chlorthalidone 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 Chlorthalidone GMP manufacturer or Chlorthalidone GMP API supplier for your needs.
A Chlorthalidone CoA (Certificate of Analysis) is a formal document that attests to Chlorthalidone's compliance with Chlorthalidone specifications and serves as a tool for batch-level quality control.
Chlorthalidone CoA mostly includes findings from lab analyses of a specific batch. For each Chlorthalidone 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.
Chlorthalidone may be tested according to a variety of international standards, such as European Pharmacopoeia (Chlorthalidone EP), Chlorthalidone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chlorthalidone USP).
