Synopsis
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
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]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 120MG
USFDA APPLICATION NUMBER - 18602
DOSAGE - TABLET;ORAL - 30MG
USFDA APPLICATION NUMBER - 18602
DOSAGE - TABLET;ORAL - 60MG
USFDA APPLICATION NUMBER - 18602
DOSAGE - TABLET;ORAL - 90MG
USFDA APPLICATION NUMBER - 18602
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120MG
USFDA APPLICATION NUMBER - 20062
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180MG
USFDA APPLICATION NUMBER - 20062
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240MG
USFDA APPLICATION NUMBER - 20062
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300MG
USFDA APPLICATION NUMBER - 20062
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 360...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 360MG
USFDA APPLICATION NUMBER - 20062
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20092
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20092
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20092
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120MG
USFDA APPLICATION NUMBER - 20401
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180MG
USFDA APPLICATION NUMBER - 20401
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240MG
USFDA APPLICATION NUMBER - 20401
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300MG
USFDA APPLICATION NUMBER - 20401
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 360...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 360MG
USFDA APPLICATION NUMBER - 20401
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 420...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 420MG
USFDA APPLICATION NUMBER - 20401
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 120M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 120MG
USFDA APPLICATION NUMBER - 21392
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG
USFDA APPLICATION NUMBER - 21392
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240MG
USFDA APPLICATION NUMBER - 21392
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300MG
USFDA APPLICATION NUMBER - 21392
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 360M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 360MG
USFDA APPLICATION NUMBER - 21392
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 420M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 420MG
USFDA APPLICATION NUMBER - 21392
Related Excipient Companies
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]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]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]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]CD Formulation
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]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]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]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]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
Controlled & Modified Release
Solubilizers
Thickeners and Stabilizers
Direct Compression
Granulation
Taste Masking
Film Formers & Plasticizers
Parenteral
Disintegrants & Superdisintegrants
Lubricants & Glidants
Chewable & Orodispersible Aids
Topical
Co-Processed Excipients
Emulsifying Agents
API Stability Enhancers
Empty Capsules
Rheology Modifiers
Surfactant & Foaming Agents
Vegetarian Capsules
Coloring Agents
Soft Gelatin
Digital Content
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
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
18
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 Dyalac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dyalac, including repackagers and relabelers. The FDA regulates Dyalac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dyalac 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 Dyalac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dyalac supplier is an individual or a company that provides Dyalac active pharmaceutical ingredient (API) or Dyalac finished formulations upon request. The Dyalac suppliers may include Dyalac API manufacturers, exporters, distributors and traders.
click here to find a list of Dyalac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dyalac DMF (Drug Master File) is a document detailing the whole manufacturing process of Dyalac active pharmaceutical ingredient (API) in detail. Different forms of Dyalac DMFs exist exist since differing nations have different regulations, such as Dyalac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dyalac DMF submitted to regulatory agencies in the US is known as a USDMF. Dyalac USDMF includes data on Dyalac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dyalac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dyalac 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 Dyalac Drug Master File in Japan (Dyalac JDMF) empowers Dyalac 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 Dyalac JDMF during the approval evaluation for pharmaceutical products. At the time of Dyalac 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 Dyalac 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 Dyalac Drug Master File in Korea (Dyalac KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dyalac. The MFDS reviews the Dyalac KDMF as part of the drug registration process and uses the information provided in the Dyalac KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dyalac 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 Dyalac API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dyalac suppliers with KDMF on PharmaCompass.
A Dyalac CEP of the European Pharmacopoeia monograph is often referred to as a Dyalac Certificate of Suitability (COS). The purpose of a Dyalac CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dyalac EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dyalac to their clients by showing that a Dyalac CEP has been issued for it. The manufacturer submits a Dyalac CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dyalac CEP holder for the record. Additionally, the data presented in the Dyalac CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dyalac DMF.
A Dyalac CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dyalac 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 Dyalac suppliers with CEP (COS) on PharmaCompass.
A Dyalac written confirmation (Dyalac WC) is an official document issued by a regulatory agency to a Dyalac manufacturer, verifying that the manufacturing facility of a Dyalac active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dyalac APIs or Dyalac finished pharmaceutical products to another nation, regulatory agencies frequently require a Dyalac WC (written confirmation) as part of the regulatory process.
click here to find a list of Dyalac 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 Dyalac as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dyalac 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 Dyalac 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 Dyalac and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dyalac NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dyalac suppliers with NDC on PharmaCompass.
Dyalac 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 Dyalac 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 Dyalac GMP manufacturer or Dyalac GMP API supplier for your needs.
A Dyalac CoA (Certificate of Analysis) is a formal document that attests to Dyalac's compliance with Dyalac specifications and serves as a tool for batch-level quality control.
Dyalac CoA mostly includes findings from lab analyses of a specific batch. For each Dyalac 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.
Dyalac may be tested according to a variety of international standards, such as European Pharmacopoeia (Dyalac EP), Dyalac JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dyalac USP).
