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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-03-03
Pay. Date : 2015-10-06
DMF Number : 29703
Submission : 2015-09-28
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-06-05
Written Confirmation Number : WC-0370
Address of the Firm :
Registrant Name : Narsha Farm Co., Ltd.
Registration Date : 2019-12-03
Registration Number : 20191203-130-H-353-47
Manufacturer Name : Alkem Laboratories Limited
Manufacturer Address : Plot No 289-290, GIDC, AT & POST: Ankleshwar City: Ankleshwar, Dist: Bharuch, Gujarat State India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24685
Submission : 2011-03-17
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-06-05
Written Confirmation Number : WC-0370
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-24
Pay. Date : 2013-11-19
DMF Number : 27637
Submission : 2013-11-01
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-06-05
Written Confirmation Number : WC-0370
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25152
Submission : 2011-07-29
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-06-05
Written Confirmation Number : WC-0370
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23679
Submission : 2010-04-26
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-06-05
Written Confirmation Number : WC-0370
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25260
Submission : 2011-09-24
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-06-05
Written Confirmation Number : WC-0370
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24884
Submission : 2011-05-06
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-06-05
Written Confirmation Number : WC-0370
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-06
Pay. Date : 2022-08-17
DMF Number : 28289
Submission : 2014-06-19
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-06-05
Written Confirmation Number : WC-0370
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-01
Pay. Date : 2012-11-08
DMF Number : 26519
Submission : 2012-10-23
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-06-05
Written Confirmation Number : WC-0370
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-07
Pay. Date : 2014-04-21
DMF Number : 27909
Submission : 2014-02-13
Status : Active
Type : II
Date of Issue : 2020-03-13
Valid Till : 2022-09-05
Written Confirmation Number : WC-0385
Address of the Firm :
Details:
Bevacizumab is a vascular endothelial growth factor inhibitor for the treatment of metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first or second-line treatment.
Lead Product(s): Bevacizumab
Therapeutic Area: Oncology Brand Name: Avastin-Generic
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2023
Lead Product(s) : Bevacizumab
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Enzene Biosciences Launches Bevacizumab
Details : Bevacizumab is a vascular endothelial growth factor inhibitor for the treatment of metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first or second-line treatment.
Brand Name : Avastin-Generic
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 29, 2023
Details:
Through collaboration, Lupin with Enzene will launch enz-124 (cetuximab) in India, the 1st biosimilar developed for Cetuximab, sold under the brand Erbitux. Cetuximab, a chimeric monoclonal antibody, is used as a targeted therapy for metastatic colorectal cancer and SCCHN.
Lead Product(s): Cetuximab
Therapeutic Area: Oncology Brand Name: enz-124
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Lupin Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration May 30, 2023
Lupin Announces the Launch of Cetuximab
Details : Through collaboration, Lupin with Enzene will launch enz-124 (cetuximab) in India, the 1st biosimilar developed for Cetuximab, sold under the brand Erbitux. Cetuximab, a chimeric monoclonal antibody, is used as a targeted therapy for metastatic colorecta...
Brand Name : enz-124
Molecule Type : Large molecule
Upfront Cash : Undisclosed
May 30, 2023
Details:
Adalimumab-bwwd is being launched for treating autoimmune disease like rheumatoid arthritis and ankylosis spondylitis. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2023
Lead Product(s) : Adalimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Alkem Subsidiary Enzene Launches Adalimumab Biosimilar in India
Details : Adalimumab-bwwd is being launched for treating autoimmune disease like rheumatoid arthritis and ankylosis spondylitis. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 23, 2023
Details:
Zidavi, which is a novel combination of ceftazidime and avibactam, a preferred treatment against OXA-48-like and Klebsiella pneumoniae carbapenemase-producing carbapenem-resistant Enterobacteriaceae for pyelonephritis or Complicated Urinary Tract Infections.
Lead Product(s): Ceftazidime,Avibactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Zidavi
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 31, 2023
Lead Product(s) : Ceftazidime,Avibactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Zidavi, which is a novel combination of ceftazidime and avibactam, a preferred treatment against OXA-48-like and Klebsiella pneumoniae carbapenemase-producing carbapenem-resistant Enterobacteriaceae for pyelonephritis or Complicated Urinary Tract Infecti...
Brand Name : Zidavi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 31, 2023
Details:
Theramex has entered into an agreement with Enzene Biosciences to develop, register and commercialise a biosimilar drug of Roche’s reference medicine RoActemra® (Tocilizumab). Tocilizumab will be available in parenteral vials, subcutaneous prefilled syringes and autoinjectors.
Lead Product(s): Tocilizumab,Methotrexate
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Large molecule
Sponsor: Theramex
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 23, 2021
Lead Product(s) : Tocilizumab,Methotrexate
Therapeutic Area : Immunology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Theramex
Deal Size : Undisclosed
Deal Type : Agreement
Details : Theramex has entered into an agreement with Enzene Biosciences to develop, register and commercialise a biosimilar drug of Roche’s reference medicine RoActemra® (Tocilizumab). Tocilizumab will be available in parenteral vials, subcutaneous prefilled s...
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Undisclosed
December 23, 2021
Details:
Ibuprofen and Famotidine Tablets is AB-rated generic therapeutic equivalent version of Horizon Medicines LLC’s Duexis® Tablets, 800 mg/26.6 mg.
Lead Product(s): Ibuprofen,Famotidine
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 04, 2021
Lead Product(s) : Ibuprofen,Famotidine
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Alkem Laboratories Launches Ibuprofen, Famotidine Tablets in US Market
Details : Ibuprofen and Famotidine Tablets is AB-rated generic therapeutic equivalent version of Horizon Medicines LLC’s Duexis® Tablets, 800 mg/26.6 mg.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 04, 2021
Details:
Avipiravir has received authorization from the Drug Controller General of India (DCGI) for restricted emergency use in India.
Lead Product(s): Favipiravir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Alfluenza
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2020
Lead Product(s) : Favipiravir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Alkem Labs launches Alfluenza for Coronavirus Treatment
Details : Avipiravir has received authorization from the Drug Controller General of India (DCGI) for restricted emergency use in India.
Brand Name : Alfluenza
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 05, 2020
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Brand Name : TRAMADOL HYDROCHLORIDE AN...
Dosage Strength : 325MG;37.5MG
Packaging :
Approval Date : 2012-03-30
Application Number : 202076
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : AMLODIPINE BESYLATE
Dosage Strength : EQ 5MG BASE
Packaging :
Approval Date : 2009-05-04
Application Number : 78925
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : AMLODIPINE BESYLATE
Dosage Strength : EQ 2.5MG BASE
Packaging :
Approval Date : 2009-05-04
Application Number : 78925
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : AMLODIPINE BESYLATE
Dosage Strength : EQ 10MG BASE
Packaging :
Approval Date : 2009-05-04
Application Number : 78925
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Dosage Form : TABLET;ORAL
Brand Name : AMLODIPINE AND OLMESARTAN...
Dosage Strength : EQ 10MG BASE;40MG
Packaging :
Approval Date : 2017-08-14
Application Number : 209042
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Dosage Form : TABLET;ORAL
Brand Name : AMLODIPINE AND OLMESARTAN...
Dosage Strength : EQ 5MG BASE;20MG
Packaging :
Approval Date : 2017-08-14
Application Number : 209042
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Dosage Form : TABLET;ORAL
Brand Name : AMLODIPINE AND OLMESARTAN...
Dosage Strength : EQ 10MG BASE;20MG
Packaging :
Approval Date : 2017-08-14
Application Number : 209042
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Dosage Form : TABLET;ORAL
Brand Name : AMLODIPINE AND OLMESARTAN...
Dosage Strength : EQ 5MG BASE;40MG
Packaging :
Approval Date : 2017-08-14
Application Number : 209042
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form : TABLET;ORAL
Brand Name : DEXTROAMP SACCHARATE, AMP...
Dosage Strength : 3.75MG;3.75MG;3.75MG;3...
Packaging :
Approval Date : 2023-10-06
Application Number : 217787
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form : TABLET;ORAL
Brand Name : DEXTROAMP SACCHARATE, AMP...
Dosage Strength : 7.5MG;7.5MG;7.5MG;7.5M...
Packaging :
Approval Date : 2023-10-06
Application Number : 217787
Regulatory Info : RX
Registration Country : USA
Inspections and registrations
ABOUT THIS PAGE
Alkem Laboratories is a supplier offers 65 products (APIs, Excipients or Intermediates).
Find a price of Amlodipine Besylate bulk with DMF, WC offered by Alkem Laboratories
Find a price of Duloxetine Hydrochloride bulk with DMF, WC offered by Alkem Laboratories
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Find a price of Rasagiline Mesylate bulk with DMF, WC offered by Alkem Laboratories
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Find a price of MED-300179/E (INTERMEDIATE) bulk with DMF offered by Alkem Laboratories
Find a price of EZETIMIBE USP bulk with DMF offered by Alkem Laboratories
Find a price of Amlodipine Besylate bulk offered by Alkem Laboratories
Find a price of Benzoyl Peroxide bulk offered by Alkem Laboratories
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