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19 Oct 2024
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https://www.fiercepharma.com/pharma/judge-upholds-msns-generic-entresto-approval-novartis-continues-attempts-defend-heart
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-17
Pay. Date : 2020-11-10
DMF Number : 20996
Submission : 2007-10-30
Status : Active
Type : II
Certificate Number : CEP 2021-314 - Rev 00
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 2594
Status : Valid
Registration Number : 229MF10088
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.
Initial Date of Registration : 2017-04-26
Latest Date of Registration :
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0005
Start Marketing Date : 2010-03-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2012-04-13
Registration Number : Su342-8-ND
Manufacturer Name : MSN Laboratories PVT LTD
Manufacturer Address : Sy. No. 317 , 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), Sangareddy District, Pincode-502 329, Telangana, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-09
Pay. Date : 2012-12-06
DMF Number : 23533
Submission : 2010-02-16
Status : Active
Type : II
Certificate Number : R1-CEP 2014-019 - Rev 00
Issue Date : 2020-08-31
Type : Chemical
Substance Number : 2641
Status : Valid
Registration Number : 230MF10024
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.
Initial Date of Registration : 2018-02-14
Latest Date of Registration :
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0006
Start Marketing Date : 2010-03-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2020-08-20
Registration Number : No. 173-26-ND(2)
Manufacturer Name : MSN Laboratories Private Limited
Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), Sangareddy District, Pin code : 502 329, Telangana, India.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-16
Pay. Date : 2014-04-25
DMF Number : 23889
Submission : 2010-06-15
Status : Active
Type : II
Certificate Number : CEP 2012-067 - Rev 02
Issue Date : 2023-10-24
Type : Chemical
Substance Number : 2422
Status : Valid
Registration Number : 229MF10042
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.
Initial Date of Registration : 2017-02-15
Latest Date of Registration :
Date of Issue : 2019-08-16
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm :
NDC Package Code : 50370-0028
Start Marketing Date : 2011-12-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2019-08-06
Registration Number : 20180308-209-J-187(2)
Manufacturer Name : MSN Pharmachem Private Limited
Manufacturer Address : Plot No. 212/ A,B,C,D, Phase-II, IDA Pashamylaram, Pashamylaram (Village), Patancheru (Mandal), Sangareddy District, 502 307, Telangana India.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-21
Pay. Date : 2013-09-11
DMF Number : 21523
Submission : 2008-04-08
Status : Active
Type : II
Certificate Number : R1-CEP 2011-387 - Rev 01
Issue Date : 2023-06-29
Type : Chemical
Substance Number : 2576
Status : Valid
Registration Number : 230MF10097
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.
Initial Date of Registration : 2018-08-02
Latest Date of Registration :
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0014
Start Marketing Date : 2010-03-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-17
Pay. Date : 2017-02-27
DMF Number : 24181
Submission : 2010-09-15
Status : Active
Type : II
Certificate Number : R1-CEP 2013-005 - Rev 00
Issue Date : 2019-02-20
Type : Chemical
Substance Number : 2601
Status : Valid
Registration Number : 301MF10024
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.
Initial Date of Registration : 2019-06-28
Latest Date of Registration :
Date of Issue : 2020-04-15
Valid Till : 2023-05-19
Written Confirmation Number : WC-0281new2
Address of the Firm :
NDC Package Code : 50379-0008
Start Marketing Date : 2012-07-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Celltrion Pharmaceutical Co., Ltd.
Registration Date : 2023-08-30
Registration Number : 20130415-196-I-227-11(8)
Manufacturer Name : MSN Organics Private Limited
Manufacturer Address : Sy. No. 224/A, Bibinagar(Village), Bibinagar(Mandal), Yadadri Bhuvanagiri District, Telangana, Pincode: 508 126, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20867
Submission : 2007-09-17
Status : Active
Type : II
Certificate Number : CEP 2006-208 - Rev 06
Issue Date : 2024-01-31
Type : Chemical
Substance Number : 1287
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0003
Start Marketing Date : 2010-03-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-05-04
Pay. Date : 2015-04-29
DMF Number : 20580
Submission : 2007-06-07
Status : Active
Type : II
Certificate Number : R1-CEP 2012-091 - Rev 00
Issue Date : 2019-09-13
Type : Chemical
Substance Number : 2583
Status : Valid
Date of Issue : 2019-08-16
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm :
NDC Package Code : 50370-0003
Start Marketing Date : 2010-04-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2024-06-28
Registration Number : 20200221-209-J-431(A)
Manufacturer Name : MSN Pharmachem Private Limited
Manufacturer Address : Plot. No. 182 to 186 ,192-A, 193 to 197 & 212/A,B,C,D,Phase-II, IDA Pashamylaram, Pashamylaram(Village), Patancheru(Mandal), Sangareddy District, Telangana, Pincode-502 307, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-11
Pay. Date : 2013-07-02
DMF Number : 20755
Submission : 2007-08-03
Status : Active
Type : II
Certificate Number : CEP 2015-360 - Rev 02
Issue Date : 2024-04-30
Type : Chemical
Substance Number : 2254
Status : Valid
Date of Issue : 2019-08-16
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm :
NDC Package Code : 50370-0001
Start Marketing Date : 2010-04-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2021-02-25
Registration Number : 20210225-209-J-841
Manufacturer Name : MSN Pharmachem Private Limited
Manufacturer Address : Plot No.: 182 to 186, 192-A, 193 to 197 & Plot No. 212/A, B, C, D, Phase-II, IDA Pashamylaram, Pashamylaram(Village), Patancheru(Mandal), Sangareddy District, Pin Code - 502 307, Telangana, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-22
Pay. Date : 2014-10-17
DMF Number : 20850
Submission : 2007-09-10
Status : Active
Type : II
Certificate Number : R1-CEP 2010-060 - Rev 02
Issue Date : 2023-01-18
Type : Chemical
Substance Number : 2296
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0025
Start Marketing Date : 2010-03-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-11
Pay. Date : 2013-07-03
DMF Number : 20712
Submission : 2007-07-25
Status : Active
Type : II
Certificate Number : R1-CEP 2015-188 - Rev 02
Issue Date : 2022-09-28
Type : Chemical
Substance Number : 2631
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0002
Start Marketing Date : 2010-03-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : JSP Co., Ltd.
Registration Date : 2023-03-23
Registration Number : 20190220-209-J-215(13)
Manufacturer Name : MSN Laboratories Private Limited
Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), Sangareddy District, Pin code : 502 329, Telangana, India.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34519
Submission : 2020-01-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38710
Submission : 2023-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38509
Submission : 2023-09-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26480
Submission : 2012-10-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-16
Pay. Date : 2022-05-06
DMF Number : 34697
Submission : 2020-05-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40612
Submission : 2024-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34714
Submission : 2020-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32658
Submission : 2018-03-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39697
Submission : 2024-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-12
Pay. Date : 2014-06-27
DMF Number : 27829
Submission : 2013-12-24
Status : Active
Type : II
CEP/COS
Certificate Numbers : R0-CEP 2021-043 - Rev 00
Status : Valid
Issue Date : 2023-04-11
Type : Chemical
Substance Number : 1386
CEP/COS
Certificate Numbers : CEP 2006-208 - Rev 06
Status : Valid
Issue Date : 2024-01-31
Type : Chemical
Substance Number : 1287
CEP/COS
Certificate Numbers : CEP 2022-496 - Rev 00
Status : Valid
Issue Date : 2024-06-17
Type : Chemical
Substance Number : 3011
CEP/COS
Certificate Numbers : R0-CEP 2020-253 - Rev 00
Status : Valid
Issue Date : 2022-01-25
Type : Chemical
Substance Number : 2970
CEP/COS
Certificate Numbers : CEP 2017-041 - Rev 03
Status : Valid
Issue Date : 2023-10-13
Type : Chemical
Substance Number : 2757
CEP/COS
Certificate Numbers : CEP 2021-434 - Rev 01
Status : Valid
Issue Date : 2023-10-24
Type : Chemical
Substance Number : 2757
CEP/COS
Certificate Numbers : CEP 2014-285 - Rev 01
Status : Valid
Issue Date : 2024-02-16
Type : Chemical
Substance Number : 2617
CEP/COS
Certificate Numbers : CEP 2019-331 - Rev 01
Status : Valid
Issue Date : 2023-10-24
Type : Chemical
Substance Number : 2898
CEP/COS
Certificate Numbers : R1-CEP 2016-025 - Rev 00
Status : Valid
Issue Date : 2022-09-15
Type : Chemical
Substance Number : 2640
CEP/COS
Certificate Numbers : CEP 2020-177 - Rev 00
Status : Valid
Issue Date : 2024-03-19
Type : Chemical
Substance Number : 2191
Registration Number : 304MF10113
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2022-08-03
Latest Date of Registration : 2023-05-10
JDMF
Registration Number : 302MF10087
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2020-07-22
Latest Date of Registration : 2021-05-10
Registration Number : 229MF10088
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2017-04-26
Latest Date of Registration : 2022-11-16
JDMF
Registration Number : 230MF10024
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2018-02-14
Latest Date of Registration : 2018-02-14
JDMF
Registration Number : 230MF10090
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2018-07-26
Latest Date of Registration : 2019-05-16
Registration Number : 305MF10092
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2023-08-02
Latest Date of Registration : 2023-08-02
Registration Number : 224MF10094
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2012-04-27
Latest Date of Registration : 2021-06-01
Registration Number : 229MF10042
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2017-02-15
Latest Date of Registration : 2023-12-13
Registration Number : 301MF10024
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2019-06-28
Latest Date of Registration : 2024-01-17
JDMF
Registration Number : 230MF10097
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2018-08-02
Latest Date of Registration : 2018-08-02
About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...
About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...
About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...
About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...
About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...
About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...
About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...
About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...
About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...
About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...
Details:
Palborest (palbociclib) is a piperazine pyridopyrimidine3, second generation cyclin-dependent kinase inhibitor. Approved in combination with hormonal therapies for hormone receptor positive, human epidermal growth factor receptor negative breast cancer.
Lead Product(s): Palbociclib
Therapeutic Area: Oncology Brand Name: Palborest
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 17, 2023
Lead Product(s) : Palbociclib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Breast Cancer Treatment Made More Affordable & Accessible with Launch of World’s First Branded G...
Details : Palborest (palbociclib) is a piperazine pyridopyrimidine3, second generation cyclin-dependent kinase inhibitor. Approved in combination with hormonal therapies for hormone receptor positive, human epidermal growth factor receptor negative breast cancer.
Brand Name : Palborest
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 17, 2023
Details:
Lacosamide Tablets, USP (generic version of Vimpat), indicated for the prevention and control of seizures, enhances the slow inactivation of voltage-gated sodium channels without affecting the fast inactivation of voltage-gated sodium channels.
Lead Product(s): Lacosamide
Therapeutic Area: Neurology Brand Name: Lacosamide-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Breckenridge Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
Lead Product(s) : Lacosamide
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Breckenridge Pharmaceutical
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Lacosamide Tablets, USP (generic version of Vimpat), indicated for the prevention and control of seizures, enhances the slow inactivation of voltage-gated sodium channels without affecting the fast inactivation of voltage-gated sodium channels.
Brand Name : Lacosamide-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 19, 2022
Details:
Solifenacin succinatei immediate release tablet is a muscarinic receptor antagonist and Mirabegron capsule is a potent and selective β3-adrenoceptor agonist, indicated for the treatment of overactive bladder.
Lead Product(s): Solifenacin Succinate,Mirabegron
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2022
Lead Product(s) : Solifenacin Succinate,Mirabegron
Therapeutic Area : Urology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
MSN Laboratories Gets CDSCO Panel Nod For FDCs Solifenacin, Mirabegron Capsules
Details : Solifenacin succinatei immediate release tablet is a muscarinic receptor antagonist and Mirabegron capsule is a potent and selective β3-adrenoceptor agonist, indicated for the treatment of overactive bladder.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 30, 2022
Details:
Under the License Agreement, Vanda granted MSN and Impax a non-exclusive license to manufacture and commercialize MSN's version of HETLIOZ® in the U.S. effective March 13, 2035, unless prior to that date Vanda obtains pediatric exclusivity for HETLIOZ.
Lead Product(s): Tasimelteon
Therapeutic Area: Genetic Disease Brand Name: Hetlioz
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Vanda Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 14, 2022
Lead Product(s) : Tasimelteon
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Recipient : Vanda Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Vanda Pharmaceuticals Settles HETLIOZ® Patent Litigation with MSN
Details : Under the License Agreement, Vanda granted MSN and Impax a non-exclusive license to manufacture and commercialize MSN's version of HETLIOZ® in the U.S. effective March 13, 2035, unless prior to that date Vanda obtains pediatric exclusivity for HETLIOZ.
Brand Name : Hetlioz
Molecule Type : Small molecule
Upfront Cash : Undisclosed
January 14, 2022
Details:
Company rolled out the first generic version of Cangrelor is an intravenous platelet P2Y12 antagonist ) used to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis.
Lead Product(s): Cangrelor
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 01, 2021
Lead Product(s) : Cangrelor
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
MSN Labs Launches Generic Cangrelor, a New Drug for PCI To Reduce Risk of MI
Details : Company rolled out the first generic version of Cangrelor is an intravenous platelet P2Y12 antagonist ) used to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 01, 2021
Details:
Molnupiravir is an experimental drug having antiviral properties and is currently under clinical-stage study for COVID treatment.
Lead Product(s): Molnupiravir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2021
Lead Product(s) : Molnupiravir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
MSN Lab Begins Phase III Clinical Trial of Molnupiravir Capsules for Covid Treatment in India
Details : Molnupiravir is an experimental drug having antiviral properties and is currently under clinical-stage study for COVID treatment.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 25, 2021
Details:
Posaconazole has been launched under the brand name PosaOne as 100 mg Delayed Release tablets and 300 mg injections, respectively. The drug has also been approved by the Drug Controller General of India (DGCI).
Lead Product(s): Posaconazole
Therapeutic Area: Infections and Infectious Diseases Brand Name: PosaOne
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2021
Lead Product(s) : Posaconazole
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
MSN Labs Launch Indigenous Drug Posaconazole to Treat Black Fungus
Details : Posaconazole has been launched under the brand name PosaOne as 100 mg Delayed Release tablets and 300 mg injections, respectively. The drug has also been approved by the Drug Controller General of India (DGCI).
Brand Name : PosaOne
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 22, 2021
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ABIRATERONE ACETATE
Dosage Strength : 250MG
Approval Date : 2019-07-10
Application Number : 210686
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ABIRATERONE ACETATE
Dosage Strength : 500MG
Approval Date : 2024-04-24
Application Number : 210686
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : SUSPENSION; ORAL
Proprietary Name : ACYCLOVIR
Dosage Strength : 200MG/5ML
Approval Date : 2023-03-09
Application Number : 217393
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : AFATINIB
Dosage Strength : 20MG
Approval Date :
Application Number : 210804
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : AFATINIB
Dosage Strength : 30MG
Approval Date :
Application Number : 210804
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : AFATINIB
Dosage Strength : 40MG
Approval Date :
Application Number : 210804
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ALBENDAZOLE
Dosage Strength : 200MG
Approval Date : 2021-01-21
Application Number : 213435
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD :
TE Code :
ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Proprietary Name : ALOGLIPTIN AND METFORMIN...
Dosage Strength : 12.5MG/500MG
Approval Date :
Application Number : 210212
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Proprietary Name : ALOGLIPTIN AND METFORMIN...
Dosage Strength : 12.5MG/1000MG
Approval Date :
Application Number : 210212
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ALOGLIPTIN
Dosage Strength : EQ 6.25MG BASE
Approval Date :
Application Number : 210213
RX/OTC/DISCN :
RLD :
TE Code :
Excipients
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36940
Submission : 2022-03-31
Status : Active
Type : IV
Excipients Web Link
Inspections and registrations
District Decision : No Action Indicated
Inspection End Date : 2011-08-05
City : Patancheru, Medak Distric...
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2011-08-05
District Decision : No Action Indicated
Inspection End Date : 2012-03-09
City : Medak District
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2012-03-09
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-08-30
City : Nalgonda District
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-08-30
District Decision : No Action Indicated
Inspection End Date : 2014-06-13
City : Patancheru, Medak Distric...
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-06-13
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-02-06
City : Medak District
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-02-06
District Decision : No Action Indicated
Inspection End Date : 2015-04-03
City : Medak District
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2015-04-03
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-06-10
City : Patancheru, Medak Distric...
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-06-10
District Decision : No Action Indicated
Inspection End Date : 2014-10-31
City : Bollaram
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-10-31
District Decision : No Action Indicated
Inspection End Date : 2017-07-21
City : Rangareddy District
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2017-07-21
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-06-30
City : Chandampet
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-06-30
Type : GMP Certificates
Number : DE_HH_01_GM...
EudraGMDP Key : 17261
Country : India
Issue Date :
Post Code : Pin Code 502307
NCA Ref : 18689
City : Patancheru (Mandal), Me...
Type : GMP Certificates
Number : DE_HH_01_GM...
EudraGMDP Key : 17261
Country : India
Issue Date :
Post Code : Pin Code 502307
NCA Ref : 18689
City : Patancheru (Mandal), Me...
Type : GMP Certificates
Number : DE_HH_01_GM...
EudraGMDP Key : 17261
Country : India
Issue Date :
Post Code : Pin Code 502307
NCA Ref : 18689
City : Patancheru (Mandal), Me...
Type : GMP Certificates
Number : 450-4/2014-...
EudraGMDP Key : 23822
Country : India
Issue Date :
Post Code : 508126
NCA Ref : 2.3822139403...
City : Nalgonda District
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MSN Pharmachem Pvt Ltd MSN Group of Companies is a supplier offers 535 products (APIs, Excipients or Intermediates).
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