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API SUPPLIERS
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Dibasic Calcium Phosphate Dihydrate
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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Topical
Taste Masking
Coating Systems & Additives
Film Formers & Plasticizers
Thickeners and Stabilizers
Direct Compression
Parenteral
Granulation
Controlled & Modified Release
Solubilizers
Co-Processed Excipients
Chewable & Orodispersible Aids
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Disintegrants & Superdisintegrants
Emulsifying Agents
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Soft Gelatin
Surfactant & Foaming Agents
Digital Content
DATA COMPILATION #PharmaFlow
Market Place
ABOUT THIS PAGE
A Dibasic Calcium Phosphate Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dibasic Calcium Phosphate Dihydrate, including repackagers and relabelers. The FDA regulates Dibasic Calcium Phosphate Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dibasic Calcium Phosphate Dihydrate supplier is an individual or a company that provides Dibasic Calcium Phosphate Dihydrate active pharmaceutical ingredient (API) or Dibasic Calcium Phosphate Dihydrate finished formulations upon request. The Dibasic Calcium Phosphate Dihydrate suppliers may include Dibasic Calcium Phosphate Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Dibasic Calcium Phosphate Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dibasic Calcium Phosphate Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dibasic Calcium Phosphate Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Dibasic Calcium Phosphate Dihydrate DMFs exist exist since differing nations have different regulations, such as Dibasic Calcium Phosphate Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dibasic Calcium Phosphate Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Dibasic Calcium Phosphate Dihydrate USDMF includes data on Dibasic Calcium Phosphate Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dibasic Calcium Phosphate Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate Drug Master File in Japan (Dibasic Calcium Phosphate Dihydrate JDMF) empowers Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate suppliers with JDMF 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 Dibasic Calcium Phosphate Dihydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dibasic Calcium Phosphate Dihydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dibasic Calcium Phosphate Dihydrate suppliers with NDC on PharmaCompass.
Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate GMP manufacturer or Dibasic Calcium Phosphate Dihydrate GMP API supplier for your needs.
A Dibasic Calcium Phosphate Dihydrate CoA (Certificate of Analysis) is a formal document that attests to Dibasic Calcium Phosphate Dihydrate's compliance with Dibasic Calcium Phosphate Dihydrate specifications and serves as a tool for batch-level quality control.
Dibasic Calcium Phosphate Dihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Dibasic Calcium Phosphate Dihydrate 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.
Dibasic Calcium Phosphate Dihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Dibasic Calcium Phosphate Dihydrate EP), Dibasic Calcium Phosphate Dihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dibasic Calcium Phosphate Dihydrate USP).
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