Synopsis
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CEP/COS
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EU WC
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Australia
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South Africa
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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Trusted Partner for Innovative, Sustainable, and High-Quality API Development and Production.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37094
Submission : 2022-06-01
Status :
Type : II
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...
Trusted Partner for Innovative, Sustainable, and High-Quality API Development and Production.
About the Company : Alven Laboratories is a pharmaceutical company specializing in the development, scale-up, and production of original and generic Active Pharmaceutical Ingredients (APIs). With expe...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standar...
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Drugs in Development
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DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 2...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 25MG BASE
USFDA APPLICATION NUMBER - 203389
DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 7...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 75MG BASE
USFDA APPLICATION NUMBER - 203389
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Fillers, Diluents & Binders
Controlled & Modified Release
Thickeners and Stabilizers
Disintegrants & Superdisintegrants
Direct Compression
Lubricants & Glidants
Granulation
Co-Processed Excipients
Taste Masking
Film Formers & Plasticizers
Empty Capsules
Solubilizers
Chewable & Orodispersible Aids
Coloring Agents
Emulsifying Agents
Rheology Modifiers
Topical
Vegetarian Capsules
API Stability Enhancers
Surfactant & Foaming Agents
Parenteral
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgels
Grade : Parenteral, Oral, Topical
Application : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical
Excipient Details : Propylene glycol is used as a solvent & stabilizer in injections. It is also used in topical semi-solids & as a plasticizer in soft capsules.
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Cysteamine Bitartrate 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 Cysteamine Bitartrate manufacturer or Cysteamine Bitartrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cysteamine Bitartrate manufacturer or Cysteamine Bitartrate supplier.
PharmaCompass also assists you with knowing the Cysteamine Bitartrate API Price utilized in the formulation of products. Cysteamine Bitartrate API Price is not always fixed or binding as the Cysteamine Bitartrate Price is obtained through a variety of data sources. The Cysteamine Bitartrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A PROCYSBI manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PROCYSBI, including repackagers and relabelers. The FDA regulates PROCYSBI manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PROCYSBI 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 PROCYSBI manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PROCYSBI supplier is an individual or a company that provides PROCYSBI active pharmaceutical ingredient (API) or PROCYSBI finished formulations upon request. The PROCYSBI suppliers may include PROCYSBI API manufacturers, exporters, distributors and traders.
click here to find a list of PROCYSBI suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PROCYSBI DMF (Drug Master File) is a document detailing the whole manufacturing process of PROCYSBI active pharmaceutical ingredient (API) in detail. Different forms of PROCYSBI DMFs exist exist since differing nations have different regulations, such as PROCYSBI USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PROCYSBI DMF submitted to regulatory agencies in the US is known as a USDMF. PROCYSBI USDMF includes data on PROCYSBI's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PROCYSBI USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PROCYSBI 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 PROCYSBI Drug Master File in Japan (PROCYSBI JDMF) empowers PROCYSBI 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 PROCYSBI JDMF during the approval evaluation for pharmaceutical products. At the time of PROCYSBI 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 PROCYSBI 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 PROCYSBI as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for PROCYSBI 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 PROCYSBI 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 PROCYSBI and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PROCYSBI NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of PROCYSBI suppliers with NDC on PharmaCompass.
PROCYSBI 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 PROCYSBI 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 PROCYSBI GMP manufacturer or PROCYSBI GMP API supplier for your needs.
A PROCYSBI CoA (Certificate of Analysis) is a formal document that attests to PROCYSBI's compliance with PROCYSBI specifications and serves as a tool for batch-level quality control.
PROCYSBI CoA mostly includes findings from lab analyses of a specific batch. For each PROCYSBI 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.
PROCYSBI may be tested according to a variety of international standards, such as European Pharmacopoeia (PROCYSBI EP), PROCYSBI JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PROCYSBI USP).
