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JDMF
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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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Canada
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FDF
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Stock Recap #PipelineProspector
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API SUPPLIERS
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
EU-WC
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
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USDMF
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38749
Submission : 2023-09-14
Status :
Type : II
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 : 33846
Submission : 2019-05-30
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Date of Issue : 2022-06-15
Valid Till : 2025-07-28
Written Confirmation Number : WC-0186
Address of the Firm : Sy No.10/G-1, Gaddapotharam (V), Jinnaram (M), Sangareddy District, Pincode 5023...
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
About the Company : Zeal MediPharma is a globally recognized Star One Export House, serving customers in over 50 countries for more than two decades. We specialize in sourcing and exporting high-quali...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
About the Company : Lee Pharma Ltd, established in 1997, is a research-driven pharmaceutical company focused on developing, synthesizing, and commercializing high-quality APIs, intermediates, and fini...
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...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
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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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DKSH
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX ...
Application : Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
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]ACG Worldwide
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]Gangwal Chemicals
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
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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]Fillers, Diluents & Binders
Lubricants & Glidants
Empty Capsules
Thickeners and Stabilizers
Coating Systems & Additives
Direct Compression
Taste Masking
Disintegrants & Superdisintegrants
Co-Processed Excipients
Chewable & Orodispersible Aids
Coloring Agents
Film Formers & Plasticizers
Emulsifying Agents
Granulation
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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PharmaCompass offers a list of Cariprazine 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 Cariprazine Hydrochloride manufacturer or Cariprazine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cariprazine Hydrochloride manufacturer or Cariprazine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Cariprazine Hydrochloride API Price utilized in the formulation of products. Cariprazine Hydrochloride API Price is not always fixed or binding as the Cariprazine Hydrochloride Price is obtained through a variety of data sources. The Cariprazine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A VRAYLAR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of VRAYLAR, including repackagers and relabelers. The FDA regulates VRAYLAR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. VRAYLAR 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 VRAYLAR manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A VRAYLAR supplier is an individual or a company that provides VRAYLAR active pharmaceutical ingredient (API) or VRAYLAR finished formulations upon request. The VRAYLAR suppliers may include VRAYLAR API manufacturers, exporters, distributors and traders.
click here to find a list of VRAYLAR suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A VRAYLAR DMF (Drug Master File) is a document detailing the whole manufacturing process of VRAYLAR active pharmaceutical ingredient (API) in detail. Different forms of VRAYLAR DMFs exist exist since differing nations have different regulations, such as VRAYLAR USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A VRAYLAR DMF submitted to regulatory agencies in the US is known as a USDMF. VRAYLAR USDMF includes data on VRAYLAR's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The VRAYLAR USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of VRAYLAR suppliers with USDMF on PharmaCompass.
A VRAYLAR written confirmation (VRAYLAR WC) is an official document issued by a regulatory agency to a VRAYLAR manufacturer, verifying that the manufacturing facility of a VRAYLAR active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting VRAYLAR APIs or VRAYLAR finished pharmaceutical products to another nation, regulatory agencies frequently require a VRAYLAR WC (written confirmation) as part of the regulatory process.
click here to find a list of VRAYLAR 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 VRAYLAR as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for VRAYLAR 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 VRAYLAR 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 VRAYLAR and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a VRAYLAR NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of VRAYLAR suppliers with NDC on PharmaCompass.
VRAYLAR 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 VRAYLAR 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 VRAYLAR GMP manufacturer or VRAYLAR GMP API supplier for your needs.
A VRAYLAR CoA (Certificate of Analysis) is a formal document that attests to VRAYLAR's compliance with VRAYLAR specifications and serves as a tool for batch-level quality control.
VRAYLAR CoA mostly includes findings from lab analyses of a specific batch. For each VRAYLAR 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.
VRAYLAR may be tested according to a variety of international standards, such as European Pharmacopoeia (VRAYLAR EP), VRAYLAR JP (Japanese Pharmacopeia) and the US Pharmacopoeia (VRAYLAR USP).
