07 Mar 2024
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31 Oct 2023
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Latest Content by PharmaCompass
Aspen API. More than just an API.
About
CPhI India 2024CPhI India 2024
Industry Trade Show
Attending
26-28 November, 2024
TIDES Europe 2024TIDES Europe 2024
Industry Trade Show
Exhibiting
12-14 November, 2024
Industry Trade Show
Not Confirmed
14-17 October, 2024
CONTACT DETAILS
Events
Webinars & Exhibitions
CPhI India 2024CPhI India 2024
Industry Trade Show
Attending
26-28 November, 2024
TIDES Europe 2024TIDES Europe 2024
Industry Trade Show
Exhibiting
12-14 November, 2024
Industry Trade Show
Not Confirmed
14-17 October, 2024
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07 Mar 2024
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31 Oct 2023
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https://www.aspenapi.com/news/gold-medal-for-aspen-api-in-ecovadis-evaluation/
31 Oct 2023
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05 Jul 2023
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21 Jun 2023
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https://www.aspenapi.com/news/get-to-know-the-aspen-api-sales-managers-interview-with-blandine-le-tallec-sales-manager-aspen-api/
13 Jun 2023
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https://www.aspenapi.com/news/get-to-know-the-aspen-api-sales-managers-interview-with-norman-van-zoggel-senior-sales-manager-aspen-api/
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8855
Submission : 1990-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34868
Submission : 2020-06-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10119
Submission : 1993-02-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34647
Submission : 2020-09-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6421
Submission : 1986-06-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35224
Submission : 2020-10-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-10-25
Pay. Date : 2012-12-19
DMF Number : 6914
Submission : 1987-04-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10493
Submission : 1993-09-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7099
Submission : 1987-08-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34883
Submission : 2020-06-09
Status : Active
Type : II
Details:
The agreements aim to support Aspen for commercialization of Sandostatin LAR Depot (octreotide acetate), which is indicated for long-term treatment of acromegaly & severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Brand Name: Sandostatin LAR Depot
Study Phase: ApprovedProduct Type: Peptide
Recipient: Sandoz B2B
Deal Size: $99.9 million Upfront Cash: Undisclosed
Deal Type: Agreement December 04, 2023
Lead Product(s) : Octreotide Acetate
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Recipient : Sandoz B2B
Deal Size : $99.9 million
Deal Type : Agreement
Aspen Concludes Two Significant Agreements with Sandoz for China and Europe
Details : The agreements aim to support Aspen for commercialization of Sandostatin LAR Depot (octreotide acetate), which is indicated for long-term treatment of acromegaly & severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
Brand Name : Sandostatin LAR Depot
Molecule Type : Peptide
Upfront Cash : Undisclosed
December 04, 2023
Details:
PNEUMOSIL® (pneumococcal polysaccharide conjugate vaccine – adsorbed, 10 Valent), a well-designed vaccine, provide comparable protection by targeting the most prevalent serotypes of the bacterium causing serious illness in developing countries.
Lead Product(s): Pneumococcal Polysaccharide Conjugate Vaccine
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Pneumosil
Study Phase: ApprovedProduct Type: Vaccine
Sponsor: Gates Foundation
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Funding December 12, 2022
Lead Product(s) : Pneumococcal Polysaccharide Conjugate Vaccine
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Gates Foundation
Deal Size : $30.0 million
Deal Type : Funding
Details : PNEUMOSIL® (pneumococcal polysaccharide conjugate vaccine – adsorbed, 10 Valent), a well-designed vaccine, provide comparable protection by targeting the most prevalent serotypes of the bacterium causing serious illness in developing countries.
Brand Name : Pneumosil
Molecule Type : Vaccine
Upfront Cash : Undisclosed
December 12, 2022
Details:
PNEUMOSIL® (Pneumococcal Conjugate Vaccine – adsorbed, 10 Valent), a well-designed vaccine with relevant serotypes, provide comparable protection by targeting the most prevalent serotypes of the bacterium causing serious illness in developing countries.
Lead Product(s): 10 Valent Pneumococcal Polysaccharide Conjugate Vaccine
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Pneumosil
Study Phase: ApprovedProduct Type: Vaccine
Sponsor: Serum Institute of India
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 31, 2022
Lead Product(s) : 10 Valent Pneumococcal Polysaccharide Conjugate Vaccine
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Serum Institute of India
Deal Size : Undisclosed
Deal Type : Collaboration
Details : PNEUMOSIL® (Pneumococcal Conjugate Vaccine – adsorbed, 10 Valent), a well-designed vaccine with relevant serotypes, provide comparable protection by targeting the most prevalent serotypes of the bacterium causing serious illness in developing countrie...
Brand Name : Pneumosil
Molecule Type : Vaccine
Upfront Cash : Undisclosed
August 31, 2022
Details:
EIKANCE (atropine sulfate monohydrate eye drops) are available on prescription for children aged 4 to 14 years, as a treatment to slow the progression of myopia and may be initiated in children when myopia progresses by 1 or more diopters per year.
Lead Product(s): Atropine Sulfate
Therapeutic Area: Ophthalmology Brand Name: Eikance
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2022
Lead Product(s) : Atropine Sulfate
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Australia Registers First Eye Drops to Slow Short-sightedness Progress in Children
Details : EIKANCE (atropine sulfate monohydrate eye drops) are available on prescription for children aged 4 to 14 years, as a treatment to slow the progression of myopia and may be initiated in children when myopia progresses by 1 or more diopters per year.
Brand Name : Eikance
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 18, 2022
Details:
Debiopharm to enter into this new alliance with Aspen, a well-established and trusted pharmaceutical partner for the commercialization of Trelstar® in South Africa and recognize the therapeutic benefits that Trelstar® could bring to prostate cancer patients in this region.
Lead Product(s): Triptorelin Pamoate
Therapeutic Area: Oncology Brand Name: Trelstar
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Debiopharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership February 01, 2022
Lead Product(s) : Triptorelin Pamoate
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Debiopharm
Deal Size : Undisclosed
Deal Type : Partnership
Debiopharm And Aspen Partner To Launch Prostate Cancer Drug Trelstar® In South Africa
Details : Debiopharm to enter into this new alliance with Aspen, a well-established and trusted pharmaceutical partner for the commercialization of Trelstar® in South Africa and recognize the therapeutic benefits that Trelstar® could bring to prostate cancer pat...
Brand Name : Trelstar
Molecule Type : Peptide
Upfront Cash : Undisclosed
February 01, 2022
Details:
The license under discussion would enable Aspen, using COVID-19 vaccine JNJ-78436735, drug substance supplied by Johnson & Johnson, to produce Aspen-branded finished vaccine for sale to public sector markets in Africa.
Lead Product(s): Ad26.COV2.S
Therapeutic Area: Infections and Infectious Diseases Brand Name: JNJ-78436735
Study Phase: ApprovedProduct Type: Vaccine
Sponsor: Johnson & Johnson
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement November 30, 2021
Lead Product(s) : Ad26.COV2.S
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Johnson & Johnson
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Johnson & Johnson Discussions to License its COVID-19 Vaccine to Aspen Reach Advanced Stage
Details : The license under discussion would enable Aspen, using COVID-19 vaccine JNJ-78436735, drug substance supplied by Johnson & Johnson, to produce Aspen-branded finished vaccine for sale to public sector markets in Africa.
Brand Name : JNJ-78436735
Molecule Type : Vaccine
Upfront Cash : Undisclosed
November 30, 2021
Details:
The transaction includes Trustan, Altosec, Zuvamor, Ciavor, Grantryl and Aspen Granisetron brands. To secure uninterrupted patient access to these medicines, the parties have also signed a manufacturing and supply agreement.
Lead Product(s): Esomeprazole Magnesium
Therapeutic Area: Gastroenterology Brand Name: Trustan
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Acino Pharma
Deal Size: $119.4 million Upfront Cash: Undisclosed
Deal Type: Acquisition October 22, 2021
Lead Product(s) : Esomeprazole Magnesium
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Acino Pharma
Deal Size : $119.4 million
Deal Type : Acquisition
Acino Acquires Selected Aspen Brands in South Africa
Details : The transaction includes Trustan, Altosec, Zuvamor, Ciavor, Grantryl and Aspen Granisetron brands. To secure uninterrupted patient access to these medicines, the parties have also signed a manufacturing and supply agreement.
Brand Name : Trustan
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 22, 2021
Details:
Avion Pharmaceuticals gets exclusive rights to relaunch Cenestin® in the USA. Cenestin® is the only plant-derived mixture of nine conjugated estrogens indicated for treatment of moderate to severe symptoms of vasomotor, and vulvar and vaginal atrophy due to menopause.
Lead Product(s): Conjugated Estrogens
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Cenestin
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Avion Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership November 12, 2020
Lead Product(s) : Conjugated Estrogens
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Avion Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Partnership
Aspen Concludes Strategic Partnership with U.S-Based Avion Pharmaceuticals
Details : Avion Pharmaceuticals gets exclusive rights to relaunch Cenestin® in the USA. Cenestin® is the only plant-derived mixture of nine conjugated estrogens indicated for treatment of moderate to severe symptoms of vasomotor, and vulvar and vaginal atrophy d...
Brand Name : Cenestin
Molecule Type : Small molecule
Upfront Cash : Undisclosed
November 12, 2020
Details:
Under the terms of the agreement, Mylan Ireland Limited will acquire the commercialisation rights and related intellectual property relating to Aspen’s Thrombosis Business in Europe which includes Arixtra, Fraxiparine, Mono-Embolex and Orgaran.
Lead Product(s): Fondaparinux Sodium
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Arixtra
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Viatris
Deal Size: $757.2 million Upfront Cash: $310.4 million
Deal Type: Acquisition September 08, 2020
Lead Product(s) : Fondaparinux Sodium
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Viatris
Deal Size : $757.2 million
Deal Type : Acquisition
Divestment of Aspen’s European Thrombosis Business to Mylan and Withdrawal of Cautionary
Details : Under the terms of the agreement, Mylan Ireland Limited will acquire the commercialisation rights and related intellectual property relating to Aspen’s Thrombosis Business in Europe which includes Arixtra, Fraxiparine, Mono-Embolex and Orgaran.
Brand Name : Arixtra
Molecule Type : Small molecule
Upfront Cash : $310.4 million
September 08, 2020
Details:
The acquisition strengthens Sandoz’s presence in the hospital channel by complementing the broad Sandoz portfolio and pipeline of hospital generic and biosimilar products in Japan like Lidocaine Hydrochloride.
Lead Product(s): Lidocaine Hydrochloride
Therapeutic Area: Neurology Brand Name: Lidocaine HCl-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Sandoz B2B
Deal Size: $440.0 million Upfront Cash: $330.0 million
Deal Type: Acquisition January 31, 2020
Lead Product(s) : Lidocaine Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Sandoz B2B
Deal Size : $440.0 million
Deal Type : Acquisition
Sandoz completes acquisition of Aspen’s Japanese operations, strengthening its position in world...
Details : The acquisition strengthens Sandoz’s presence in the hospital channel by complementing the broad Sandoz portfolio and pipeline of hospital generic and biosimilar products in Japan like Lidocaine Hydrochloride.
Brand Name : Lidocaine HCl-Generic
Molecule Type : Small molecule
Upfront Cash : $330.0 million
January 31, 2020
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Aspen API is a supplier offers 109 products (APIs, Excipients or Intermediates).
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