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NEWS #PharmaBuzz
24 Jun 2025
// PR NEWSWIRE
29 Jan 2025
// PR NEWSWIRE
18 Dec 2024
// PR NEWSWIRE
24 Jan 2024
// FDA
21 Dec 2023
// INDIAN PHARMA POST
Drugs in Development
Lead Product(s) : Ethanol,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Breckenridge Gets FDA Nod For Dehydrated Alcohol Injection, Ablysinol Generic
Details : Ablysinol-Generic is an ablative agent indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy.
Product Name : Ablysinol-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 24, 2025
Lead Product(s) : Roflumilast,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Senores Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Senores Pharma Gains After Arm Inks Pact to Acquire Roflumilast Tablets
Details : Senores acquire the USFDA-approved abbreviated new drug application for Roflumilast, indicated as a treatment to reduce the risk of COPD exacerbations, from Breckenridge.
Product Name : Roflumilast-Generic
Product Type : Miscellaneous
Upfront Cash : Undisclosed
February 21, 2025
Lead Product(s) : Everolimus,Inapplicable
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Breckenridge Gains FDA Nod for Everolimus, Afinitor Disperz Generic
Details : Afinitor Disperz (everolimus) is an mTOR inhibitor small molecule drug candidate, which is currently being evaluated for the treatment of tuberous sclerosis complex.
Product Name : Afinitor Disperz-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 29, 2025
Lead Product(s) : Methadone Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Breckenridge Announces final FDA Approval for Methadone Hydrochloride Multi-Dose Injection
Details : Methadone HCl Multi-Dose Vial is a Mu opioid receptor agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 18, 2024
Lead Product(s) : Cabazitaxel,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Natco Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cabazitaxel Intravenous Powder (generic for Jevtana Kit®), is a Microtubule inhibitor, available in the 60mg/1.5mL (40mg/mL) strength used fo the treatment of Prostate cancer.
Product Name : Cabazitaxel-Generic
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
August 01, 2022
Lead Product(s) : Cabazitaxel,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Natco Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Natco Pharma's Partner Breckenridge Gets FDA Nod for Prostate Cancer Drug
Details : Cabazitaxel intravenous powder of strength 60mg/1.5ml (40mg/ml), is an antineoplastic agent and a microtubule inhibitor used in the treatment of prostate cancer.
Product Name : Cabazitaxel-Generic
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
July 25, 2022
Lead Product(s) : Dabigatran Etexilate Mesylate,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dabigatran Etexilate Capsules (generic for Pradaxa®), is good at preventing blood clots that can cause a stroke or heart attack, but it can be very expensive and must be used carefully in patients with kidney problems.
Product Name : Dabigatran Etexilate-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 22, 2022
Lead Product(s) : Miglustat,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Breckenridge Announces Approval of its ANDA for Miglustat Capsules (generic for Zavesca®)
Details : Miglustat Capsules (generic for Zavesca), 100mg strength, is an inhibitor of the enzyme glucosylceramide synthase, which is a glucosyl transferase enzyme responsible for first step in synthesis of most glycosphingolipids.
Product Name : Miglustat-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 21, 2022
Lead Product(s) : Penicillamine,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cuprimine-Generic (penicillamine) is a copper chelating agent, small molecule drug candidate, which is being evauated for the treatment of Wilson's disease.
Product Name : Cuprimine-Generic
Product Type : Amino Acid
Upfront Cash : Inapplicable
April 20, 2022
Lead Product(s) : Penicillamine,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Recipient : Aggrega Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Penicillamine Capsules, USP (generic for Cuprimine®), a chelating agent recommended for the removal of excess copper in patients with Wilson's disease also in cystinuria, and in patients with severe, active rheumatoid arthritis.
Product Name : Pencillamine-Generic
Product Type : Amino Acid
Upfront Cash : Inapplicable
April 20, 2022
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ACETAZOLAMIDE
Dosage Strength : 125MG
Packaging :
Approval Date : 2020-04-30
Application Number : 207503
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ACETAZOLAMIDE
Dosage Strength : 250MG
Packaging :
Approval Date : 2020-04-30
Application Number : 207503
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INTRA-ARTERIAL
Brand Name : DEHYDRATED ALCOHOL
Dosage Strength : 99% (5ML)
Packaging :
Approval Date : 2025-06-23
Application Number : 219444
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : AMITRIPTYLINE HYDROCHLORI...
Dosage Strength : 10MG
Packaging :
Approval Date : 2022-06-06
Application Number : 216243
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : AMITRIPTYLINE HYDROCHLORI...
Dosage Strength : 25MG
Packaging :
Approval Date : 2022-06-06
Application Number : 216243
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : AMITRIPTYLINE HYDROCHLORI...
Dosage Strength : 50MG
Packaging :
Approval Date : 2022-06-06
Application Number : 216243
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : AMITRIPTYLINE HYDROCHLORI...
Dosage Strength : 75MG
Packaging :
Approval Date : 2022-06-06
Application Number : 216243
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : AMITRIPTYLINE HYDROCHLORI...
Dosage Strength : 100MG
Packaging :
Approval Date : 2022-06-06
Application Number : 216243
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : AMITRIPTYLINE HYDROCHLORI...
Dosage Strength : 150MG
Packaging :
Approval Date : 2022-06-06
Application Number : 216243
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : APIXABAN
Dosage Strength : 2.5MG
Packaging :
Approval Date : 2021-07-26
Application Number : 209845
Regulatory Info : DISCN
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
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Breckenridge Pharmaceutical is a supplier offers 1 products (APIs, Excipients or Intermediates).
Find a price of Ethacrynic Acid bulk with DMF offered by Breckenridge Pharmaceutical
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