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// FDA
15 Aug 2024
// PRESS RELEASE
08 Aug 2024
// PRESS RELEASE
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Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
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23 Oct 2024
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-23-2024-21885.pdf
15 Aug 2024
// PRESS RELEASE
08 Aug 2024
// PRESS RELEASE
25 Jun 2024
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13 Jun 2024
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14 May 2024
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Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2006-03-02
Registration Number : 20060302-52-B-228-06
Manufacturer Name : TOWA PHARMACEUTICAL EUROPE, SL
Manufacturer Address : C/de Sant Marti 75-97, 08107 Martorelles, Barcelona, Spain
Details:
Company has been granted manufacturing and marketing approval for the generic version for zonisamide capsule for the treatment of Parkinson's disease.
Lead Product(s): Zonisamide
Therapeutic Area: Neurology Brand Name: Zonegran-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2024
Lead Product(s) : Zonisamide
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Manufacturing and Marketing Approval for Three Ingredients and Eight Items
Details : Company has been granted manufacturing and marketing approval for the generic version for zonisamide capsule for the treatment of Parkinson's disease.
Brand Name : Zonegran-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 15, 2024
Details:
Esomeprazole magnesium hydrate capsules is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.
Lead Product(s): Esomeprazole Magnesium
Therapeutic Area: Gastroenterology Brand Name: Esomeprazole-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2024
Lead Product(s) : Esomeprazole Magnesium
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Notice of Approval for Esomeprazole Capsules with New Manufacturing Plant Addition
Details : Esomeprazole magnesium hydrate capsules is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.
Brand Name : Esomeprazole-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 14, 2024
Details:
Edirol® Tablets 0.5 µg/0.75 µg (generic name: eldecalcitol, hereafter, Edirol Tablet) for an osteoporosis treatment (an active vitamin D3 preparation). Chugai manufactures Edirol Tablet and supplies to Towa.
Lead Product(s): Eldecalcitol
Therapeutic Area: Musculoskeletal Brand Name: Edirol
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Chugai Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2022
Lead Product(s) : Eldecalcitol
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved
Recipient : Chugai Pharmaceutical
Deal Size : Not Applicable
Deal Type : Not Applicable
Chugai and Towa Launch Edirol Tablet for Osteoporosis Treatment
Details : Edirol® Tablets 0.5 µg/0.75 µg (generic name: eldecalcitol, hereafter, Edirol Tablet) for an osteoporosis treatment (an active vitamin D3 preparation). Chugai manufactures Edirol Tablet and supplies to Towa.
Brand Name : Edirol
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 09, 2022
Details:
Edirol (eldecalcitol), is an active vitamin D3 derivative created based on Chugai’s long-standing vitamin D research. Chugai takes responsibilities as a holder of the approval, Towa will be responsible for marketing and providing information on use of Edirol.
Lead Product(s): Eldecalcitol
Therapeutic Area: Musculoskeletal Brand Name: Edirol
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Chugai Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 15, 2022
Lead Product(s) : Eldecalcitol
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved
Recipient : Chugai Pharmaceutical
Deal Size : Not Applicable
Deal Type : Not Applicable
Chugai Obtains Regulatory Approval for Osteoporosis Treatment Edirol Tablet
Details : Edirol (eldecalcitol), is an active vitamin D3 derivative created based on Chugai’s long-standing vitamin D research. Chugai takes responsibilities as a holder of the approval, Towa will be responsible for marketing and providing information on use of ...
Brand Name : Edirol
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 15, 2022
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.
Lead Product(s): Cabazitaxel
Therapeutic Area: Oncology Brand Name: Cabazitaxel-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Natco Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2022
Lead Product(s) : Cabazitaxel
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Natco Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Cabazitaxel-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 01, 2022
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.
Lead Product(s): Cabazitaxel
Therapeutic Area: Oncology Brand Name: Cabazitaxel-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Natco Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2022
Lead Product(s) : Cabazitaxel
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Natco Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Cabazitaxel-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 25, 2022
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.
Lead Product(s): Dabigatran Etexilate Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Dabigatran Etexilate-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2022
Lead Product(s) : Dabigatran Etexilate Mesylate
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Dabigatran Etexilate-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 22, 2022
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.
Lead Product(s): Miglustat
Therapeutic Area: Genetic Disease Brand Name: Miglustat-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2022
Lead Product(s) : Miglustat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Miglustat-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 21, 2022
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.
Lead Product(s): Penicillamine
Therapeutic Area: Genetic Disease Brand Name: Pencillamine-Generic
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Aggrega Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2022
Lead Product(s) : Penicillamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Recipient : Aggrega Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Pencillamine-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 20, 2022
Details:
Cuprimine-Generic (penicillamine) is a copper chelating agent, small molecule drug candidate, which is being evauated for the treatment of Wilson's disease.
Lead Product(s): Penicillamine
Therapeutic Area: Genetic Disease Brand Name: Cuprimine-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2022
Lead Product(s) : Penicillamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Cuprimine-Generic (penicillamine) is a copper chelating agent, small molecule drug candidate, which is being evauated for the treatment of Wilson's disease.
Brand Name : Cuprimine-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 20, 2022
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