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API SUPPLIERS
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
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.
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
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 : 33846
Submission : 2019-05-30
Status :
Type : II
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API Imports and Exports
Drugs in Development
Lead Product(s) : Cariprazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
December 16, 2022
Lead Product(s) : Cariprazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
May 23, 2022
Lead Product(s) : Cariprazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
February 22, 2022
Lead Product(s) : Cariprazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
October 29, 2021
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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, 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 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, COA and API Price 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, COA and API Price 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, API price, 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).
