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  • SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 1064MG/3.9ML (272.82MG/ML)
  • SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 441MG/1.6ML (275.63MG/ML)
  • SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 662MG/2.4ML (275.83MG/ML)
  • SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 882MG/3.2ML (275.63MG/ML)
  • SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 675MG/2.4ML (281.25MG/ML)

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

Aripiprazole Lauroxil manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Aripiprazole Lauroxil 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 Aripiprazole Lauroxil manufacturer or Aripiprazole Lauroxil supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aripiprazole Lauroxil manufacturer or Aripiprazole Lauroxil supplier.

PharmaCompass also assists you with knowing the Aripiprazole Lauroxil API Price utilized in the formulation of products. Aripiprazole Lauroxil API Price is not always fixed or binding as the Aripiprazole Lauroxil Price is obtained through a variety of data sources. The Aripiprazole Lauroxil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

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 Manufacturers

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

Aripiprazole Lauroxil Suppliers

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

click here to find a list of Aripiprazole Lauroxil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Aripiprazole Lauroxil USDMF

A Aripiprazole Lauroxil DMF (Drug Master File) is a document detailing the whole manufacturing process of Aripiprazole Lauroxil active pharmaceutical ingredient (API) in detail. Different forms of Aripiprazole Lauroxil DMFs exist exist since differing nations have different regulations, such as Aripiprazole Lauroxil USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Aripiprazole Lauroxil DMF submitted to regulatory agencies in the US is known as a USDMF. Aripiprazole Lauroxil USDMF includes data on Aripiprazole Lauroxil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aripiprazole Lauroxil USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Aripiprazole Lauroxil suppliers with USDMF on PharmaCompass.

Aripiprazole Lauroxil NDC

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 Aripiprazole Lauroxil as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Aripiprazole Lauroxil API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Aripiprazole Lauroxil 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Aripiprazole Lauroxil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aripiprazole Lauroxil NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Aripiprazole Lauroxil suppliers with NDC on PharmaCompass.

Aripiprazole Lauroxil GMP

Aripiprazole Lauroxil 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 Aripiprazole Lauroxil 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 Aripiprazole Lauroxil GMP manufacturer or Aripiprazole Lauroxil GMP API supplier for your needs.

Aripiprazole Lauroxil CoA

A Aripiprazole Lauroxil CoA (Certificate of Analysis) is a formal document that attests to Aripiprazole Lauroxil's compliance with Aripiprazole Lauroxil specifications and serves as a tool for batch-level quality control.

Aripiprazole Lauroxil CoA mostly includes findings from lab analyses of a specific batch. For each Aripiprazole Lauroxil 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.

Aripiprazole Lauroxil may be tested according to a variety of international standards, such as European Pharmacopoeia (Aripiprazole Lauroxil EP), Aripiprazole Lauroxil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aripiprazole Lauroxil USP).

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.
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