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API SUPPLIERS
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USDMF
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European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
About the Company : Polpharma API, a division of a leading Polish pharmaceutical group, has over 75 years of expertise in process development and cGMP manufacturing. Based at an FDA-approved site in C...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
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 trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Thro...
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
About the Company : Sichuan Qingmu Pharmaceutical is an innovation-driven company specializing in generic APIs, advanced intermediates, and CDMO/CMO services for small-molecule drugs. Approved by US F...
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DOSAGE - TABLET;ORAL - 0.25MG
USFDA APPLICATION NUMBER - 205422
DOSAGE - TABLET;ORAL - 0.5MG
USFDA APPLICATION NUMBER - 205422
DOSAGE - TABLET;ORAL - 1MG
USFDA APPLICATION NUMBER - 205422
DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 205422
DOSAGE - TABLET;ORAL - 3MG
USFDA APPLICATION NUMBER - 205422
DOSAGE - TABLET;ORAL - 4MG
USFDA APPLICATION NUMBER - 205422
Related Excipient Companies
SPI Pharma
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Coating Systems & Additives
Direct Compression
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Taste Masking
Excipient Details : Advantose® FS95 is spray-dried fructose coprocessed with starch, is a highly compressible pharmaceutical excipient with chewable vitamin applications.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
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
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
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
Controlled & Modified Release
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.
Pharmacopoeia Ref : NA
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Granulation
Thickeners and Stabilizers
Lubricants & Glidants
Co-Processed Excipients
Disintegrants & Superdisintegrants
Taste Masking
Chewable & Orodispersible Aids
Film Formers & Plasticizers
Empty Capsules
Vegetarian Capsules
API Stability Enhancers
Emulsifying Agents
Coloring Agents
Rheology Modifiers
Solubilizers
Parenteral
Digital Content
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Global Sales Information
US Medicaid Prescriptions
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US Patents
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ABOUT THIS PAGE
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PharmaCompass offers a list of Brexpiprazole API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Brexpiprazole manufacturer or Brexpiprazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Brexpiprazole manufacturer or Brexpiprazole supplier.
A Brexpiprazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brexpiprazole, including repackagers and relabelers. The FDA regulates Brexpiprazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brexpiprazole 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 Brexpiprazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Brexpiprazole supplier is an individual or a company that provides Brexpiprazole active pharmaceutical ingredient (API) or Brexpiprazole finished formulations upon request. The Brexpiprazole suppliers may include Brexpiprazole API manufacturers, exporters, distributors and traders.
click here to find a list of Brexpiprazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Brexpiprazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Brexpiprazole active pharmaceutical ingredient (API) in detail. Different forms of Brexpiprazole DMFs exist exist since differing nations have different regulations, such as Brexpiprazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Brexpiprazole DMF submitted to regulatory agencies in the US is known as a USDMF. Brexpiprazole USDMF includes data on Brexpiprazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Brexpiprazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Brexpiprazole 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 Brexpiprazole Drug Master File in Korea (Brexpiprazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Brexpiprazole. The MFDS reviews the Brexpiprazole KDMF as part of the drug registration process and uses the information provided in the Brexpiprazole KDMF to evaluate the safety and efficacy of the drug.
After submitting a Brexpiprazole 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 Brexpiprazole API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Brexpiprazole suppliers with KDMF on PharmaCompass.
A Brexpiprazole written confirmation (Brexpiprazole WC) is an official document issued by a regulatory agency to a Brexpiprazole manufacturer, verifying that the manufacturing facility of a Brexpiprazole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Brexpiprazole APIs or Brexpiprazole finished pharmaceutical products to another nation, regulatory agencies frequently require a Brexpiprazole WC (written confirmation) as part of the regulatory process.
click here to find a list of Brexpiprazole 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 Brexpiprazole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Brexpiprazole 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 Brexpiprazole 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 Brexpiprazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Brexpiprazole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Brexpiprazole suppliers with NDC on PharmaCompass.
Brexpiprazole 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 Brexpiprazole GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Brexpiprazole GMP manufacturer or Brexpiprazole GMP API supplier for your needs.
A Brexpiprazole CoA (Certificate of Analysis) is a formal document that attests to Brexpiprazole's compliance with Brexpiprazole specifications and serves as a tool for batch-level quality control.
Brexpiprazole CoA mostly includes findings from lab analyses of a specific batch. For each Brexpiprazole 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.
Brexpiprazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Brexpiprazole EP), Brexpiprazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Brexpiprazole USP).
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