Synopsis
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EDQM
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USP
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JP
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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
HRV Pharma - 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.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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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 : 41753
Submission : 2025-04-24
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2025-08-25
Pay. Date : 2025-08-19
DMF Number : 33846
Submission : 2019-05-30
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, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
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...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Cariprazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
U.S. FDA Approves VRAYLAR® (cariprazine) as an Adjunctive Treatment for Major Depressive Disorder
Details : VRAYLAR (cariprazine) is an oral, once-daily atypical antipsychotic approved as an adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults (1.5 or 3 mg/day), for the treatment of depressive episodes associated with ...
Product Name : Vraylar
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 16, 2022
Lead Product(s) : Cariprazine Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cariprazine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Autism Spectrum Disorder.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 30, 2022
Lead Product(s) : Cariprazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
AbbVie Presents Positive Data from Phase 3 Study of Cariprazine (VRAYLAR®) for the Adjunctive Tre...
Details : In Study 3111-301-001, cariprazine (VRAYLAR®; 1.5mg/day) achieved the primary endpoint of statistically significant improvement on MADRS total score in patients with major depressive disorder with an inadequate response to ongoing antidepressant therapy...
Product Name : Vraylar
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 23, 2022
Lead Product(s) : Cariprazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cariprazine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Schizophrenia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 10, 2022
Lead Product(s) : Cariprazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
AbbVie Submits Supplemental New Drug Application to U.S. FDA for Cariprazine (VRAYLAR®) for the A...
Details : Submission based on clinical trial results findings showing clinically and statistically significant improvement in the Montgomery-Åsberg Depression Rating Scale total score in patients with major depressive disorder treated with VRAYLAR (cariprazine) a...
Product Name : Vraylar
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 22, 2022
Lead Product(s) : Cariprazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
AbbVie's Cariprazine (VRAYLAR®) Met Primary Endpoint in Phase 3 Study as an Adjunctive Treatment ...
Details : VRAYLAR® (cariprazine), a partial agonist at dopamine D3, D2, and serotonin 5-HT1A receptors used as atypical antipsychotic, met its primary endpoint demonstrating statistically significant change from baseline to week six in MADRS total score in major ...
Product Name : Vraylar
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 29, 2021
Lead Product(s) : Cariprazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cariprazine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Generalized Anxiety Disorder.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 16, 2021
Lead Product(s) : Cariprazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cariprazine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Depression.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 02, 2021
Lead Product(s) : Cariprazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cariprazine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Schizophrenia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 08, 2020
Lead Product(s) : Cariprazine Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Cariprazine Pediatric ASD PK Study
Details : Cariprazine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Autism Spectrum Disorder.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 11, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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SPI Pharma
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
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
Empty Capsules
Lubricants & Glidants
Direct Compression
Taste Masking
Coating Systems & Additives
Co-Processed Excipients
Chewable & Orodispersible Aids
Disintegrants & Superdisintegrants
Thickeners and Stabilizers
Emulsifying Agents
Film Formers & Plasticizers
Granulation
Digital Content
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ABOUT THIS PAGE
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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, 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.
A Cariprazine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cariprazine Hydrochloride, including repackagers and relabelers. The FDA regulates Cariprazine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cariprazine Hydrochloride 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 Cariprazine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Cariprazine Hydrochloride supplier is an individual or a company that provides Cariprazine Hydrochloride active pharmaceutical ingredient (API) or Cariprazine Hydrochloride finished formulations upon request. The Cariprazine Hydrochloride suppliers may include Cariprazine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Cariprazine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cariprazine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Cariprazine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Cariprazine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Cariprazine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cariprazine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Cariprazine Hydrochloride USDMF includes data on Cariprazine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cariprazine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cariprazine Hydrochloride suppliers with USDMF on PharmaCompass.
A Cariprazine Hydrochloride written confirmation (Cariprazine Hydrochloride WC) is an official document issued by a regulatory agency to a Cariprazine Hydrochloride manufacturer, verifying that the manufacturing facility of a Cariprazine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cariprazine Hydrochloride APIs or Cariprazine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Cariprazine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Cariprazine Hydrochloride 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 Cariprazine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cariprazine Hydrochloride 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 Cariprazine Hydrochloride 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 Cariprazine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cariprazine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cariprazine Hydrochloride suppliers with NDC on PharmaCompass.
Cariprazine Hydrochloride 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 Cariprazine Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cariprazine Hydrochloride GMP manufacturer or Cariprazine Hydrochloride GMP API supplier for your needs.
A Cariprazine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Cariprazine Hydrochloride's compliance with Cariprazine Hydrochloride specifications and serves as a tool for batch-level quality control.
Cariprazine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Cariprazine Hydrochloride 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.
Cariprazine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Cariprazine Hydrochloride EP), Cariprazine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cariprazine Hydrochloride USP).
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