Taro Pharmaceutical Industries DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

02

Carbamazepine

U.S.A

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

Compamed

Not Confirmed

USDMF

CEP/COS

JDMF EU-WC NDC KDMF VMF NA Not Available For Sales AUDIT

Product
Web Link

03

Clorazepate Dipotassium

U.S.A

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

Compamed

Not Confirmed

USDMF

CEP/COS

JDMF EU-WC NDC KDMF VMF NA Not Available For Sales AUDIT

Product
Web Link

04

Etodolac

U.S.A

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

Compamed

Not Confirmed

USDMF

CEP/COS

JDMF EU-WC NDC KDMF VMF NA Not Available For Sales AUDIT

Product
Web Link

05

Mometasone Furoate

U.S.A

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

Compamed

Not Confirmed

USDMF

CEP/COS

JDMF EU-WC NDC KDMF VMF Others AUDIT

Product
Web Link

06

Warfarin Sodium

U.S.A

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

Compamed

Not Confirmed

USDMF

CEP/COS

JDMF EU-WC NDC KDMF VMF Others AUDIT

Product
Web Link

07

Amiodarone Hydrochloride

U.S.A

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

Compamed

Not Confirmed

USDMF

CEP/COS

JDMF EU-WC NDC KDMF VMF NA Not Available For Sales AUDIT

Product
Web Link

08

Granisetron Hydrochloride

U.S.A

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

Compamed

Not Confirmed

USDMF

CEP/COS

JDMF EU-WC NDC KDMF VMF NA Not Available For Sales AUDIT

Product
Web Link

09

Ondansetron Hydrochloride

U.S.A

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

Compamed

Not Confirmed

USDMF

CEP/COS

JDMF EU-WC NDC KDMF VMF NA Not Available For Sales AUDIT

Product
Web Link

10

Clomipramine Hydrochloride

U.S.A

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

Compamed

Not Confirmed

USDMF

CEP/COS JDMF EU-WC NDC KDMF VMF NA Not Available For Sales AUDIT

Product
Web Link

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USDMF

01

Adapalene Usp, Micronized

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2014-07-07

Pay. Date : 2014-03-11

DMF Number : 21208

Submission : 2008-01-02

Status : Active

Type : II

Product
Web Link

02

Amcinonide Usp Micronized

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 14374

Submission : 1999-08-30

Status : Active

Type : II

Product
Web Link

03

Amiodarone Hcl Usp

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15794

Submission : 2001-12-27

Status : Active

Type : II

Product
Web Link

04

Atovaquone Usp, Micronized

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2014-09-15

Pay. Date : 2013-03-22

DMF Number : 26906

Submission : 2013-03-21

Status : Active

Type : II

Product
Web Link

05

Azelaic Acid, Micronized

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2016-02-05

Pay. Date : 2015-11-30

DMF Number : 29484

Submission : 2015-12-01

Status : Active

Type : II

Product
Web Link

06

Azithromycin Monohydrate Usp

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2015-06-29

Pay. Date : 2015-03-02

DMF Number : 28294

Submission : 2015-03-02

Status : Active

Type : II

Product
Web Link

07

Betamethasone 17-valerate, Usp Micro...

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2015-03-16

Pay. Date : 2015-03-06

DMF Number : 15004

Submission : 2000-08-18

Status : Active

Type : II

Product
Web Link

08

Betamethasone Dipropionate Usp, Micr...

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2017-04-24

Pay. Date : 2017-04-06

DMF Number : 14651

Submission : 1999-12-30

Status : Active

Type : II

Product
Web Link

09

Butenafine Hydrochloride

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2013-06-25

Pay. Date : 2013-01-23

DMF Number : 19551

Submission : 2006-06-27

Status : Active

Type : II

Product
Web Link

10

Carbamazepine Usp

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4929

Submission : 1983-03-17

Status : Active

Type : II

Product
Web Link

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CEP/COS

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LISTED APIs

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Drugs in Development

01 Taro Pharmaceutical Industries

U.S.A

Pharmtech & Ingredients

Not Confirmed

Lead Product(s) : Acetazolamide

Therapeutic Area : Cardiology/Vascular Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Sun Pharmaceutical Industries Limited

Deal Size : Undisclosed

Deal Type : Merger

Sun Pharma Completes Taro Merger

Details : Sun Pharma will gain access to Taro's pipelines, including Diamox (acetazolamide), an carbonic anhydrase inhibitor used for treating edema due to congestive heart failure in patients.

Brand Name : Diamox

Molecule Type : Small molecule

Upfront Cash : Undisclosed

June 24, 2024

02 Taro Pharmaceutical Industries

U.S.A

Pharmtech & Ingredients

Not Confirmed

Lead Product(s) : Acetazolamide

Therapeutic Area : Cardiology/Vascular Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Sun Pharmaceutical Industries Limited

Deal Size : Undisclosed

Deal Type : Merger

Taro Shareholders Approve Merger with Sun Pharma

Details : Sun Pharma will gain access to Taro's pipelines, including Diamox (acetazolamide), an carbonic anhydrase inhibitor used for treating edema due to congestive heart failure in patients.

Brand Name : Diamox

Molecule Type : Small molecule

Upfront Cash : Undisclosed

May 23, 2024

03 Taro Pharmaceutical Industries

U.S.A

Pharmtech & Ingredients

Not Confirmed

Lead Product(s) : Acetazolamide

Therapeutic Area : Cardiology/Vascular Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Sun Pharmaceutical Industries Limited

Deal Size : Undisclosed

Deal Type : Merger

Taro Announces Merger Agreement with Sun Pharma

Details : Through the merger, Sun Pharma will gain access to Taro's pipelines, including Diamox (acetazolamide), a carbonic anhydrase inhibitor for treating edema due to congestive heart failure.

Brand Name : Diamox

Molecule Type : Small molecule

Upfront Cash : Undisclosed

January 17, 2024

04 Taro Pharmaceutical Industries

U.S.A

Pharmtech & Ingredients

Not Confirmed

Lead Product(s) : Desvenlafaxine Succinate

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Intellipharmaceutics Corporation

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Intellipharmaceutics Signs an Exclusive License & Supply Agreement with Taro Pharmaceuticals Inc. ...

Details : Company has granted Taro an exclusive license to market, sell and distribute in Canada, Desvenlafaxine Extended-release Tablets in the 50 mg and 100 mg strengths approved for sale in the Canadian market by the Pharmaceutical Drugs Directory (PDD) of Heal...

Brand Name : Desvenlafaxine-Generic

Molecule Type : Small molecule

Upfront Cash : Undisclosed

August 16, 2022

05 Taro Pharmaceutical Industries

U.S.A

Pharmtech & Ingredients

Not Confirmed

Lead Product(s) : Benzoyl Peroxide

Therapeutic Area : Dermatology

Highest Development Status : Approved

Recipient : Galderma

Deal Size : $99.3 million

Deal Type : Acquisition

Sun Pharma's US subsidiary acquires Galderma's companies in US, Japan & Canada

Details : Taro Pharmaceutical Industries, has agreed to acquire all of the outstanding capital stock of Galderma ; Proactiv YK ; The Proactiv Company ; used in the business of developing, manufacturing, marketing, selling and distributing products sold under the P...

Brand Name : Proactiv

Molecule Type : Small molecule

Upfront Cash : Undisclosed

March 09, 2022

06 Taro Pharmaceutical Industries

U.S.A

Pharmtech & Ingredients

Not Confirmed

Lead Product(s) : Benzoyl Peroxide

Therapeutic Area : Dermatology

Highest Development Status : Approved

Recipient : Alchemee

Deal Size : Undisclosed

Deal Type : Acquisition

Taro Completes Acquisition of Alchemee

Details : The acquisition includes Alchemee’s business and assets worldwide, including the Proactiv® brand. Alchemee's flagship brand, Proactiv, is America’s 1 acne routine and has been used and trusted by millions around the world for more than 25 years.

Brand Name : Proactiv

Molecule Type : Small molecule

Upfront Cash : Undisclosed

February 28, 2022

07 Taro Pharmaceutical Industries

U.S.A

Pharmtech & Ingredients

Not Confirmed

Lead Product(s) : Deferiprone

Therapeutic Area : Genetic Disease

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Taro Pharmaceutical Launches Generic Deferiprone in U.S

Details : Deferiprone is an iron chelator indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. Deferiprone is the generic version of Ferriprox®.

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 28, 2020

08 Taro Pharmaceutical Industries

U.S.A

Pharmtech & Ingredients

Not Confirmed

Lead Product(s) : Lidocaine,Tetracaine

Therapeutic Area : Neurology

Highest Development Status : Approved

Recipient : Crescita Therapeutics

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Crescita to Receive One-time Cash Payment Following Amendment to Pliaglis® U.S. Licensing Agreeme...

Details : The Company continues to pursue out-licensing partnerships with focus on approximately 20 countries where Pliaglis has already received regulatory approval.

Brand Name : Pliaglis

Molecule Type : Small molecule

Upfront Cash : $3.9 million

July 28, 2020

09 Taro Pharmaceutical Industries

U.S.A

Pharmtech & Ingredients

Not Confirmed

Lead Product(s) : Levofloxacin,Dexamethasone

Therapeutic Area : Ophthalmology

Highest Development Status : Phase III

Recipient : NTC

Deal Size : Undisclosed

Deal Type : Licensing Agreement

NTC Grants License and Distribution Rights in Israel to Taro Pharmaceutical Industries

Details : NTC Srl has granted exclusive license and distribution rights to one of its R&D products to Taro Pharmaceutical. The product combines a quinolone antibiotic with an anti-inflammatory steroid in eye drops intended to provide an appropriate treatment for p...

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Undisclosed

June 17, 2020

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FDF Dossiers

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FDA Orange Book

Canada

01

Brand Name : TARO-DIPYRIDAMOLE/ A...

U.S.A

Regulatory Info : Prescription

Registration Country : Canada

ACETYLSALICYLIC ACID

Dosage Form : CAPSULE (IMMEDIATE AND EXTENDE...

Dosage Strength : 25MG

Packaging : 30/60

Approval Date :

Application Number : 2471051

Regulatory Info : Prescription

Registration Country : Canada

Product
Web Link

02

Brand Name : TARO-ACITRETIN

U.S.A

Regulatory Info : Prescription

Registration Country : Canada

ACITRETIN

Dosage Form : CAPSULE

Dosage Strength : 10MG

Packaging : 30

Approval Date :

Application Number : 2466074

Regulatory Info : Prescription

Registration Country : Canada

Product
Web Link

03

Brand Name : TARO-ACITRETIN

U.S.A

Regulatory Info : Prescription

Registration Country : Canada

ACITRETIN

Dosage Form : CAPSULE

Dosage Strength : 25MG

Packaging : 30

Approval Date :

Application Number : 2466082

Regulatory Info : Prescription

Registration Country : Canada

Product
Web Link

04

Brand Name : TARO-ACYCLOVIR

U.S.A

Regulatory Info : Prescription

Registration Country : Canada

ACYCLOVIR

Dosage Form : OINTMENT

Dosage Strength : 5%/W/W

Packaging :

Approval Date :

Application Number : 2522306

Regulatory Info : Prescription

Registration Country : Canada

Product
Web Link

05

Brand Name : TARO-ADAPALENE/BENZO...

U.S.A

Regulatory Info : Prescription

Registration Country : Canada

ADAPALENE

Dosage Form : GEL

Dosage Strength : 0.3%/W/W

Packaging :

Approval Date :

Application Number : 2505053

Regulatory Info : Prescription

Registration Country : Canada

Product
Web Link

06

Brand Name : TARO-ADAPALENE/BENZO...

U.S.A

Regulatory Info : Prescription

Registration Country : Canada

ADAPALENE

Dosage Form : GEL

Dosage Strength : 0.1%/W/W

Packaging : 60G/70G

Approval Date :

Application Number : 2456923

Regulatory Info : Prescription

Registration Country : Canada

Product
Web Link

07

Brand Name : TARO-AMCINONIDE

U.S.A

Regulatory Info : Prescription

Registration Country : Canada

AMCINONIDE

Dosage Form : CREAM

Dosage Strength : 0.1%

Packaging : 15/30/60G

Approval Date :

Application Number : 2246714

Regulatory Info : Prescription

Registration Country : Canada

Product
Web Link

08

Brand Name : TARO-ANASTROZOLE

U.S.A

Regulatory Info : Prescription

Registration Country : Canada

ANASTROZOLE

Dosage Form : TABLET

Dosage Strength : 1MG

Packaging : 30

Approval Date :

Application Number : 2365650

Regulatory Info : Prescription

Registration Country : Canada

Product
Web Link

09

Brand Name : TARO-ATORVASTATIN

U.S.A

Regulatory Info : Prescription

Registration Country : Canada

ATORVASTATIN (ATORVASTATIN CALCIUM)

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2313707

Regulatory Info : Prescription

Registration Country : Canada

Product
Web Link

10

Brand Name : TARO-ATORVASTATIN

U.S.A

Regulatory Info : Prescription

Registration Country : Canada

ATORVASTATIN (ATORVASTATIN CALCIUM)

Dosage Form : TABLET

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number : 2313715

Regulatory Info : Prescription

Registration Country : Canada

Product
Web Link