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List of Drug Master Files (DMF) of REXULTI Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Polpharma (1)

02 Biophore India Pharmaceuticals Pvt Ltd (1)

03 Alembic Pharmaceuticals Limited (1)

04 Aurobindo Pharma Limited (1)

05 Cipla (1)

06 HONOUR LAB LTD (1)

07 Jubilant Generics (1)

08 Lupin Ltd (1)

09 MSN Laboratories (1)

10 Macleods Pharmaceuticals Limited (1)

11 Raks Pharma (1)

12 ScinoPharm Taiwan, Ltd (1)

13 Signa S.A. de C.V. (1)

14 TOPHARMAN SHANDONG CO LTD (1)

15 Teva API (1)

16 Unichem Laboratories Limited (1)

17 Zhejiang Huahai Pharmaceutical (1)

18 Zydus Lifesciences (1)

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01 BREXPIPRAZOLE (18)

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01 China (2)

02 India (12)

03 Israel (1)

04 Mexico (1)

05 Poland (1)

06 Taiwan (1)

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01 Active (18)

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01 Complete (13)

02 Blank (5)

URL Supplier Web Content
33122
Active
2018-09-29
Complete
2019-06-07
2019-04-15
II
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URL Supplier Web Content
32532
Active
2018-06-04
Complete
2018-07-10
2018-03-27
II
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URL Supplier Web Content
32995
Active
2018-12-31
N/A
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URL Supplier Web Content
33421
Active
2019-02-07
Complete
2019-05-02
2019-02-07
II
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URL Supplier Web Content
32142
Active
2017-10-30
Complete
2019-04-12
2019-01-28
II
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URL Supplier Web Content
33231
Active
2018-10-19
N/A
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URL Supplier Web Content
33437
Active
2019-01-02
Complete
2019-02-27
2018-12-20
II
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URL Supplier Web Content
33284
Active
2018-12-29
Complete
2019-02-26
2018-10-29
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Looking for 913611-97-9 / Brexpiprazole API manufacturers, exporters & distributors?

Brexpiprazole manufacturers, exporters & distributors 1

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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, Price,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.

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

API | Excipient name

Brexpiprazole

Synonyms

913611-97-9, Opc-34712, Rexulti, 7-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1h)-one, Opc 34712, 2j3ybm1k8c

Cas Number

913611-97-9

Unique Ingredient Identifier (UNII)

2J3YBM1K8C

About Brexpiprazole

Brexpiprazole is a novel D2 dopamine and serotonin 1A partial agonist, called serotonin-dopamine activity modulator (SDAM), and a potent antagonist of serotonin 2A receptors, noradrenergic alpha 1B and 2C receptors. Brexpiprazole is approved for the treatment of schizophrenia, and as an adjunctive treatment for major depressive disorder (MDD). Although it failed Phase II clinical trials for ADHD, it has been designed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia) over established adjunctive treatments for major depressive disorder (MDD).

REXULTI Manufacturers

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

REXULTI Suppliers

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

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

REXULTI USDMF

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

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

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

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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