Company profile for Aucta Pharmaceuticals

Aucta Pharmaceuticals-PSE
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Aucta Pharmaceuticals is an emerging drug product development company focusing on new branded 505(b)(2) products and technology platform-based niche generics. Aucta adopts a branded/generic hybrid model, generating both near-term product revenue and mid- to long-term investment return, aiming to become a significant specialty pharma player in the United States and China marketplace. We focus on developing enhanced products for patients with a therapeutic focus on CNS disorders, as well as Ophthalmics, and Inhalation therapies.

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CORPORATE CONTENT #SupplierSpotlight

    https://www.pharmacompass.com/pdf/party/content/aucta-pharmaceuticals-party-content-96522.pdf

    https://www.pharmacompass.com/pdf/party/content/aucta-pharmaceuticals-party-content-13729.pdf

NEWS #PharmaBuzz

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219417

FDA
30 Jun 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218380

FDA
03 Feb 2025
Aucta debuts generic Vimpat
Aucta debuts generic Vimpat

11 Mar 2024

// DRUG STORE NEWS

https://drugstorenews.com/aucta-debuts-generic-vimpat

DRUG STORE NEWS
11 Mar 2024

https://www.prnewswire.com/news-releases/aucta-pharmaceuticals-inc-aucta-pharmaceuticals-launches-motpoly-xr-lacosamide-extended-release-capsules-c-v-the-first-and-only-once-daily-formulation-of-lacosamide-302070783.html

PR NEWSWIRE
26 Feb 2024

https://www.prnewswire.com/news-releases/aucta-announced-fda-approval-of-a-generic-version-of-trileptaloxcarbazepine-oral-suspension-301694327.html#:~:text=PISCATAWAY%2C%20N.J.%2C%20Dec.,this%20product%20in%20early%202023.

PR NEWSWIRE
05 Dec 2022

https://www.prnewswire.com/news-releases/aucta-announces-fda-approval-of-a-generic-version-of-perforomist-formoterol-fumarate-inhalation-solution-301691187.html

PRNEWSWIRE
01 Dec 2022

Drugs in Development

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Details:

Motpoly (lacosamide) is an antiepileptic drug that works by blocking sodium channel alpha subunit. It is being evaluated for partial-onset seizures in adults and in pediatric patients.


Lead Product(s): Lacosamide,Inapplicable

Therapeutic Area: Neurology Brand Name: Motpoly XR

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 26, 2024

Aucta Company Banner

01

Lead Product(s) : Lacosamide,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Motpoly (lacosamide) is an antiepileptic drug that works by blocking sodium channel alpha subunit. It is being evaluated for partial-onset seizures in adults and in pediatric patients.

Product Name : Motpoly XR

Product Type : Controlled Substance

Upfront Cash : Inapplicable

February 26, 2024

Aucta Company Banner

Details:

Oxcarbazepine produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. It is indicated to treat partial seizures.


Lead Product(s): Oxcarbazepine,Inapplicable

Therapeutic Area: Neurology Brand Name: Trileptal-Generic

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 05, 2022

Aucta Company Banner

02

Lead Product(s) : Oxcarbazepine,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Oxcarbazepine produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. It is indicated to treat parti...

Product Name : Trileptal-Generic

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 05, 2022

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Details:

Formoterol Fumarate is a long-acting bronchodilator used as a long-term treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema).


Lead Product(s): Formoterol Fumarate,Inapplicable

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Perforomist-Generic

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 01, 2022

Aucta Company Banner

03

Lead Product(s) : Formoterol Fumarate,Inapplicable

Therapeutic Area : Pulmonary/Respiratory Diseases

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Formoterol Fumarate is a long-acting bronchodilator used as a long-term treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchiti...

Product Name : Perforomist-Generic

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 01, 2022

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Details:

JADENU (deferasirox) tablets for oral use and JADENU® Sprinkle (deferasirox) granules are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.


Lead Product(s): Deferasirox,Inapplicable

Therapeutic Area: Hematology Brand Name: Jadenu

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Oakrum Pharma, LLC

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 22, 2021

Aucta Company Banner

04

Lead Product(s) : Deferasirox,Inapplicable

Therapeutic Area : Hematology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Oakrum Pharma, LLC

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : JADENU (deferasirox) tablets for oral use and JADENU® Sprinkle (deferasirox) granules are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

Product Name : Jadenu

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 22, 2021

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Details:

Sirolimus is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Facial Angiofibroma.


Lead Product(s): Sirolimus,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Antibiotic

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 06, 2017

Aucta Company Banner

05

Lead Product(s) : Sirolimus,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Sirolimus is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Facial Angiofibroma.

Product Name : Undisclosed

Product Type : Antibiotic

Upfront Cash : Inapplicable

December 06, 2017

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Details:

Entecavir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Hepatitis B.


Lead Product(s): Entecavir,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 04, 2017

Aucta Company Banner

06

Lead Product(s) : Entecavir,Inapplicable

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Entecavir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Hepatitis B.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 04, 2017

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FDA Orange Book

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01

Brand Name : ARFORMOTEROL TARTRAT...

Aucta Pharmaceuticals

Dosage Form : SOLUTION; INHALATION

Proprietary Name : ARFORMOTEROL TARTRATE

Dosage Strength : EQ 0.015MG BASE/2ML

Approval Date : 2025-02-03

Application Number : 218380

RX/OTC/DISCN : RX

RLD : No

TE Code : AN

Aucta Company Banner

02

Brand Name : PYQUVI

Aucta Pharmaceuticals

Dosage Form : SUSPENSION; ORAL

Proprietary Name : PYQUVI

Dosage Strength : 22.75MG/ML

Approval Date : 2025-06-30

Application Number : 219417

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Aucta Company Banner

03

Brand Name : MOTPOLY XR

Aucta Pharmaceuticals

Dosage Form : CAPSULE, EXTENDED RELEASE; ORA...

Proprietary Name : MOTPOLY XR

Dosage Strength : 100MG

Approval Date : 2023-05-04

Application Number : 216185

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Aucta Company Banner

04

Brand Name : MOTPOLY XR

Aucta Pharmaceuticals

Dosage Form : CAPSULE, EXTENDED RELEASE; ORA...

Proprietary Name : MOTPOLY XR

Dosage Strength : 150MG

Approval Date : 2023-05-04

Application Number : 216185

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Aucta Company Banner

05

Brand Name : MOTPOLY XR

Aucta Pharmaceuticals

Dosage Form : CAPSULE, EXTENDED RELEASE; ORA...

Proprietary Name : MOTPOLY XR

Dosage Strength : 200MG

Approval Date : 2023-05-04

Application Number : 216185

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Aucta Company Banner

06

Brand Name : OXCARBAZEPINE

Aucta Pharmaceuticals

Dosage Form : SUSPENSION; ORAL

Proprietary Name : OXCARBAZEPINE

Dosage Strength : 300MG/5ML

Approval Date : 2022-11-30

Application Number : 215332

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Aucta Company Banner

07

Brand Name : ZELVYSIA

Aucta Pharmaceuticals

Dosage Form : POWDER; ORAL

Proprietary Name : ZELVYSIA

Dosage Strength : 100MG/PACKET

Approval Date : 2025-04-29

Application Number : 218645

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Aucta Company Banner

08

Brand Name : ZELVYSIA

Aucta Pharmaceuticals

Dosage Form : POWDER; ORAL

Proprietary Name : ZELVYSIA

Dosage Strength : 500MG/PACKET

Approval Date : 2025-04-29

Application Number : 218645

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Aucta Company Banner

09

Brand Name : VIGADRONE

Aucta Pharmaceuticals

Dosage Form : FOR SOLUTION; ORAL

Proprietary Name : VIGADRONE

Dosage Strength : 500MG/PACKET

Approval Date : 2018-06-21

Application Number : 210196

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

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