Aripiprazole lauroxil (USAN) API Manufacturers | Suppliers | Drug Master Files (DMF) | CEP

01

Interquim SA

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI Milan

Booth #5D89

Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

Contact Supplier

Spain

Virtual Booth

Digital Content

USDMF

Click Us!

CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Polpharma

Poland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI China

Booth #E2C71

European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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Poland

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

03

Neuland Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Biotech Outsourcing Strategies

Booth #25

Neuland Laboratories- A dedicated 100% API provider.

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India

Virtual Booth

Digital Content

USDMF

CEP/COS JDMF EU-WC NDC

KDMF VMF ASMF

AUDIT

04

Honour Lab Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PEGS Boston Summit

Not Confirmed

Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

05

GLAND PHARMA LIMITED

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PEGS Boston Summit

Not Confirmed

06

MSN Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PEGS Boston Summit

Not Confirmed

07

Pharmathen SA

Greece

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PEGS Boston Summit

Not Confirmed

08

Zydus Lifesciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PEGS Boston Summit

Not Confirmed

09

Cambrex Corporation

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PEGS Boston Summit

Not Confirmed

10

Country

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PEGS Boston Summit

Not Confirmed

Looking for 1259305-29-7 / Aripiprazole Lauroxil API manufacturers, exporters & distributors?

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API | Excipient name

Aripiprazole Lauroxil

Synonyms

1259305-29-7, Aristada, Rdc-3317, Alks 9072, Aristada initio, Aripiprazole lauroxil [usan]

Cas Number

1259305-29-7

Unique Ingredient Identifier (UNII)

B786J7A343

About Aripiprazole Lauroxil

Aripiprazole lauroxil is a long-acting injectable atypical antipsychotic drug used in the treatment of schizophrenia in adult patients. It is a prodrug of [aripiprazole], which acts as a partial agonist at the D2 and 5-HT1A receptors, and as an antagonist at the 5-HT2A receptors. Affecting about 1% of the adult population in the United States and approximately 26 million people worldwide, schizophrenia is a chronic neurological disorder that may result in impairments in cognition and executive functions. The quality of life in patients is greatly reduced due to negative health outcomes, and oftentimes the patients are faced with social stigma and discriminations. Schizophrenia is characterized by positive symptoms such as delusions, hallucinations, thought disorders, and catanoia, and negative symptoms that include social withdrawal, anhedonia, and flattening of emotional responses. D2 receptors have been the most common target for antipsychotic agents used in the treatment of schizophrenia: the positive symptoms are thought to arise from overactivity in the mesolimbic dopaminergic pathway activating D2 receptors, whereas negative symptoms may result from a decreased activity in the mesocortical dopaminergic pathway with D1 receptors predominating. In a randomized, double-blind clinical trial, treatment of aripiprazole lauroxil in adult patients with schizophrenia resulted in improvement of positive and negative symptoms scores at day 85 of treatment. Aripiprazole lauroxil was initially approved by the FDA in October 2015 under the market name Aristada for the treatment of schizophrenia. It is administered via intramuscular injection, and requires the establishment of tolerability prior to dosing in treatment-nave patients. On July 2nd, a different formulation of aripiprazole lauroxil marketed as Aristada Initio was FDA-approved for immediate initiation of Aristada at any dose. The patients may receive Aristada Initio in combination with a single 30 mg oral dose of aripiprazole to achieve appropriate levels of aripiprazole more rapidly. Long-acting injectable aripiprazole lauroxil displayed comparable efficacy and safety to aripiprazole, and reduced dosing frequency improves patient adherence.

Aripiprazole lauroxil (USAN) Manufacturers

A Aripiprazole lauroxil (USAN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aripiprazole lauroxil (USAN), including repackagers and relabelers. The FDA regulates Aripiprazole lauroxil (USAN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aripiprazole lauroxil (USAN) 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 Aripiprazole lauroxil (USAN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

Aripiprazole lauroxil (USAN) Suppliers

A Aripiprazole lauroxil (USAN) supplier is an individual or a company that provides Aripiprazole lauroxil (USAN) active pharmaceutical ingredient (API) or Aripiprazole lauroxil (USAN) finished formulations upon request. The Aripiprazole lauroxil (USAN) suppliers may include Aripiprazole lauroxil (USAN) API manufacturers, exporters, distributors and traders.

click here to find a list of Aripiprazole lauroxil (USAN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

Aripiprazole lauroxil (USAN) Manufacturers | Traders | Suppliers

We have 9 companies offering Aripiprazole lauroxil (USAN)

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Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.