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// ECONOMICTIMES
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/tariffs-should-not-dictate-how-indian-drugmakers-do-business-cipla-ceo-says/articleshow/118633708.cms
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21 Jan 2025
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// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214966
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13887
Submission : 1998-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-29
Pay. Date : 2013-03-13
DMF Number : 26299
Submission : 2012-08-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29125
Submission : 2015-03-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37668
Submission : 2023-01-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-03
Pay. Date : 2021-04-16
DMF Number : 35762
Submission : 2021-05-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-30
Pay. Date : 2023-09-22
DMF Number : 38325
Submission : 2023-07-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10710
Submission : 1994-02-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20192
Submission : 2007-03-27
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-13
Pay. Date : 2016-09-29
DMF Number : 30967
Submission : 2016-10-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29493
Submission : 2015-06-30
Status : Inactive
Type : II
Details:
Cipla has rights to market the innovative treatment, APP13007, a novel, patent protected and USFDA approved ophthalmic product, for post-operative inflammation and pain following ocular surgery.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Neurology Brand Name: APP13007
Study Phase: Approved FDFProduct Type: Steroid
Recipient: Formosa Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 18, 2025
Lead Product(s) : Clobetasol Propionate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Recipient : Formosa Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Cipla and Formosa Sign Multi-Regional Licensing Deal for Clobetasol Suspension
Details : Cipla has rights to market the innovative treatment, APP13007, a novel, patent protected and USFDA approved ophthalmic product, for post-operative inflammation and pain following ocular surgery.
Product Name : APP13007
Product Type : Steroid
Upfront Cash : Undisclosed
March 18, 2025
Details:
Afrezza (human Insulin) is the only ultra rapid-acting inhaled insulin that act as Insulin receptor agonist, indicated for the treatment of diabetes.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2024
Lead Product(s) : Insulin
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Cipla Gets CDSCO Nod to Launch Inhalation Insulin
Details : Afrezza (human Insulin) is the only ultra rapid-acting inhaled insulin that act as Insulin receptor agonist, indicated for the treatment of diabetes.
Product Name : Undisclosed
Product Type : Peptide
Upfront Cash : Not Applicable
December 11, 2024
Details:
Through the collaboration Orchid & Cipla will launch Exblifep (cefepime/enmetazobactam), which is indicated for the treatment of complicated urinary tract infections, including pyelonephritis.
Lead Product(s): Cefepime,Enmetazobactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Exblifep
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Orchid Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 29, 2024
Lead Product(s) : Cefepime,Enmetazobactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Recipient : Orchid Pharma
Deal Size : Undisclosed
Deal Type : Collaboration
Orchid Pharma and Cipla collaborate to launch antibiotic Cefepime-Enmetazobactam in India
Details : Through the collaboration Orchid & Cipla will launch Exblifep (cefepime/enmetazobactam), which is indicated for the treatment of complicated urinary tract infections, including pyelonephritis.
Product Name : Exblifep
Product Type : Small molecule
Upfront Cash : Undisclosed
June 29, 2024
Details:
Under the terms of this agreement, Takeda has granted Cipla non-exclusive patent licensing rights for the commercialization of Voltapraz (vonoprazan) in India.
Lead Product(s): Vonoprazan Fumarate
Therapeutic Area: Gastroenterology Brand Name: Voltapraz
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Takeda Pharmaceutical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 20, 2024
Lead Product(s) : Vonoprazan Fumarate
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Recipient : Takeda Pharmaceutical
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Cipla Signs Agreement With Takeda To Commercialize Vonoprazan in India
Details : Under the terms of this agreement, Takeda has granted Cipla non-exclusive patent licensing rights for the commercialization of Voltapraz (vonoprazan) in India.
Product Name : Voltapraz
Product Type : Small molecule
Upfront Cash : Undisclosed
June 20, 2024
Details:
Lanreotide generic injection is approved by FDA for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors.
Lead Product(s): Lanreotide Acetate
Therapeutic Area: Endocrinology Brand Name: Somatuline Depot-Generic
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2024
Lead Product(s) : Lanreotide Acetate
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Cipla Gets Approval for Generic Somatuline® Depot Injection (Lanreotide)
Details : Lanreotide generic injection is approved by FDA for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors.
Product Name : Somatuline Depot-Generic
Product Type : Peptide
Upfront Cash : Not Applicable
May 22, 2024
Details:
Cipla will distribute and promote Sanofi India's CNS product range, including Frisium (clobazam), an anti-epileptic medication, in India.
Lead Product(s): Clobazam
Therapeutic Area: Neurology Brand Name: Frisium
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Sanofi
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership March 27, 2024
Sanofi and Cipla Form Exclusive Distribution Partnership for CNS Portfolio in India
Details : Cipla will distribute and promote Sanofi India's CNS product range, including Frisium (clobazam), an anti-epileptic medication, in India.
Product Name : Frisium
Product Type : Small molecule
Upfront Cash : Undisclosed
March 27, 2024
Details:
The partnership allows Cipla to scale up amphotericin, conducting studies and seeking regulatory approvals for commercialization in treating fungal keratitis.
Lead Product(s): Amphotericin B
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Small molecule
Recipient: Central Drug Research Institute
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership February 15, 2024
Lead Product(s) : Amphotericin B
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Recipient : Central Drug Research Institute
Deal Size : Undisclosed
Deal Type : Partnership
Cipla Partners with CSIR-CDRI to Develop Formulation for Fungal Keratitis
Details : The partnership allows Cipla to scale up amphotericin, conducting studies and seeking regulatory approvals for commercialization in treating fungal keratitis.
Product Name : Undisclosed
Product Type : Small molecule
Upfront Cash : Undisclosed
February 15, 2024
Details:
Under the amendment, Cipla and Pulmatrix agreed to halt patient enrollment in the Ph2b study of PUR1900 (itraconazole) at 8 subjects, with Cipla assuming sole responsibility for its development.
Lead Product(s): Itraconazole
Therapeutic Area: Infections and Infectious Diseases Brand Name: PUR1900
Study Phase: Phase IIProduct Type: Small molecule
Recipient: Pulmatrix
Deal Size: Undisclosed Upfront Cash: $22.0 million
Deal Type: Agreement January 08, 2024
Lead Product(s) : Itraconazole
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Recipient : Pulmatrix
Deal Size : Undisclosed
Deal Type : Agreement
Pulmatrix Stops PUR1900 Phase 2B Enrollment To Preserve Cash
Details : Under the amendment, Cipla and Pulmatrix agreed to halt patient enrollment in the Ph2b study of PUR1900 (itraconazole) at 8 subjects, with Cipla assuming sole responsibility for its development.
Product Name : PUR1900
Product Type : Small molecule
Upfront Cash : $22.0 million
January 08, 2024
Details:
Through the acquisition, Cipla strengthen its wellness portfolio by gaining access of Nozohaem (glycine and Calcium), a unique, gel treatment for nosebleeds that stops the bleeding in moments.
Lead Product(s): Glycine,Calcium
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Nozohaem
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Actor Pharma
Deal Size: $48.6 million Upfront Cash: $48.6 million
Deal Type: Acquisition September 05, 2023
Lead Product(s) : Glycine,Calcium
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Approved
Recipient : Actor Pharma
Deal Size : $48.6 million
Deal Type : Acquisition
Cipla to Acquire South Africa-based Actor Pharma
Details : Through the acquisition, Cipla strengthen its wellness portfolio by gaining access of Nozohaem (glycine and Calcium), a unique, gel treatment for nosebleeds that stops the bleeding in moments.
Product Name : Nozohaem
Product Type : Small molecule
Upfront Cash : $48.6 million
September 05, 2023
Details:
Under the terms of the agreement, Cipla will manufacture and market Galvus (vildagliptin) and Galvus combination brands, used in the treatment of type 2 diabetes.
Lead Product(s): Vildagliptin
Therapeutic Area: Endocrinology Brand Name: Galvus
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 11, 2023
Lead Product(s) : Vildagliptin
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Recipient : Novartis Pharmaceuticals Corporation
Deal Size : Undisclosed
Deal Type : Agreement
Cipla Signs Agreement with Novartis for Diabetes Therapy Galvus Range
Details : Under the terms of the agreement, Cipla will manufacture and market Galvus (vildagliptin) and Galvus combination brands, used in the treatment of type 2 diabetes.
Product Name : Galvus
Product Type : Small molecule
Upfront Cash : Undisclosed
April 11, 2023
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