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// CNBCTV
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27 Sep 2024
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17 Sep 2024
// MONEYCONTROL
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12 Sep 2024
// ENDPTS
https://endpts.com/fda-sends-warning-letter-to-indian-drugmaker-after-finding-glass-in-injections/
10 Sep 2024
// FDA
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03 Sep 2024
// EXPRESSPHARMA
https://www.expresspharma.in/zydus-gains-final-usfda-approval-for-amantadine-extended-release-capsules-68-5-mg-and-tentative-approval-for-137-mg/
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-08
Pay. Date : 2012-12-18
DMF Number : 22999
Submission : 2009-07-31
Status : Active
Type : II
Certificate Number : CEP 2019-009 - Rev 02
Issue Date : 2024-07-05
Type : Chemical
Substance Number : 1699
Status : Valid
Registration Number : 303MF10044
Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103, Nr. Nirma University, Nr. Vaishnod
Initial Date of Registration : 2021-03-15
Latest Date of Registration :
Date of Issue : 2019-07-08
Valid Till : 2022-07-07
Written Confirmation Number : WC-0095
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 : 16680
Submission : 2003-06-27
Status : Active
Type : II
Certificate Number : R1-CEP 2004-239 - Rev 06
Issue Date : 2022-07-08
Type : Chemical
Substance Number : 2018
Status : Valid
Registration Number : 222MF10207
Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103, Nr. Nirma University, Nr. Vaishnod
Initial Date of Registration : 2010-07-26
Latest Date of Registration :
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0084
Address of the Firm :
Registrant Name : Nuri Pharm Tech
Registration Date : 2021-11-30
Registration Number : 20211130-209-J-1162
Manufacturer Name : Zydus Lifesciences Limited
Manufacturer Address : 291, GIDC, Estate, Ankleshwar, Gujarat, 393002, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17037
Submission : 2004-02-17
Status : Active
Type : II
Certificate Number : CEP 2004-098 - Rev 05
Issue Date : 2024-07-16
Type : Chemical
Substance Number : 1681
Status : Valid
Registration Number : 301MF10065
Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India
Initial Date of Registration : 2019-09-17
Latest Date of Registration :
Date of Issue : 2019-07-08
Valid Till : 2022-07-07
Written Confirmation Number : WC-0095
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 : 22684
Submission : 2009-03-31
Status : Inactive
Type : II
Certificate Number : R0-CEP 2020-221 - Rev 00
Issue Date : 2023-04-04
Type : Chemical
Substance Number : 2423
Status : Valid
Registration Number : 225MF10140
Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India
Initial Date of Registration : 2013-07-23
Latest Date of Registration :
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0080
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 : 20364
Submission : 2007-03-22
Status : Active
Type : II
Certificate Number : R0-CEP 2019-236 - Rev 01
Issue Date : 2022-07-11
Type : Chemical
Substance Number : 2640
Status : Valid
Registration Number : 303MF10088
Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103, Nr. Nirma University, Nr. Vaishnod
Initial Date of Registration : 2021-06-07
Latest Date of Registration :
NDC Package Code : 65841-155
Start Marketing Date : 2018-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2016-03-30
Registration Number : No. 4749-10-ND(1)
Manufacturer Name : Cadila Pharmaceuticals Limited
Manufacturer Address : 294, GIDC Estate, City: Ankleshwar-393 002, Dist: Bharuch, India.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18822
Submission : 2005-09-30
Status : Active
Type : II
Certificate Number : CEP 2021-079 - Rev 02
Issue Date : 2024-08-29
Type : Chemical
Substance Number : 2191
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0080
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 : 18153
Submission : 2005-03-04
Status : Inactive
Type : II
Certificate Number : R1-CEP 2009-133 - Rev 08
Issue Date : 2023-03-23
Type : Chemical
Substance Number : 2232
Status : Valid
Registration Number : 223MF10140
Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India
Initial Date of Registration : 2011-08-30
Latest Date of Registration :
Date of Issue : 2019-07-08
Valid Till : 2022-07-07
Written Confirmation Number : WC-0095
Address of the Firm :
Registrant Name : Goodwills Co., Ltd.
Registration Date : 2011-01-10
Registration Number : 20110110-122-G-94-29
Manufacturer Name : Cadila Healthcare Limited
Manufacturer Address : 291, GIDC Industrial Estate Ankleswar-393 002, Gujarat INDIA
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-01
Pay. Date : 2016-03-22
DMF Number : 14210
Submission : 1999-06-14
Status : Active
Type : II
Certificate Number : R1-CEP 2004-169 - Rev 04
Issue Date : 2022-07-07
Type : Chemical
Substance Number : 703
Status : Valid
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0084
Address of the Firm :
NDC Package Code : 65841-101
Start Marketing Date : 2018-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14977
Submission : 2000-08-01
Status : Active
Type : II
Certificate Number : R0-CEP 2019-011 - Rev 01
Issue Date : 2022-07-08
Type : Chemical
Substance Number : 2849
Status : Valid
Date of Issue : 2021-07-29
Valid Till : 2022-07-14
Written Confirmation Number : WC-0084A5
Address of the Firm :
NDC Package Code : 65841-103
Start Marketing Date : 2017-09-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2020-06-17
Registration Number : 20200206-209-J-553(1)
Manufacturer Name : Cadila Healthcare Limited
Manufacturer Address : Plot No.: 26 to 29 & 31, Dabhasa Tal - Padra, City: Dabhasa, 391440, Dist: Vadodara, Gujarat State, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-01
Pay. Date : 2017-01-10
DMF Number : 17358
Submission : 2004-05-05
Status : Active
Type : II
Certificate Number : R0-CEP 2019-017 - Rev 03
Issue Date : 2023-07-17
Type : Chemical
Substance Number : 2373
Status : Valid
Date of Issue : 2019-07-08
Valid Till : 2022-07-07
Written Confirmation Number : WC-0095
Address of the Firm :
NDC Package Code : 65841-004
Start Marketing Date : 2020-01-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE AND LAM...
Dosage Strength : EQ 600MG BASE;300MG
Approval Date : 2018-11-15
Application Number : 208990
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Proprietary Name : ACAMPROSATE CALCIUM
Dosage Strength : 333MG
Approval Date : 2017-05-26
Application Number : 205995
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : ACETAMINOPHEN
Dosage Strength : 1GM/100ML (10MG/ML)
Approval Date : 2022-10-25
Application Number : 216467
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Proprietary Name : TRAMADOL HYDROCHLORIDE A...
Dosage Strength : 325MG;37.5MG
Approval Date : 2012-09-06
Application Number : 90460
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAZOLAMIDE
Dosage Strength : 125MG
Approval Date : 2023-04-04
Application Number : 211069
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAZOLAMIDE
Dosage Strength : 250MG
Approval Date : 2023-04-04
Application Number : 211069
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ACETAZOLAMIDE SODIUM
Dosage Strength : EQ 500MG BASE/VIAL
Approval Date : 2019-04-15
Application Number : 206533
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INTRAVENOUS
Proprietary Name : ACETYLCYSTEINE
Dosage Strength : 6GM/30ML (200MG/ML)
Approval Date : 2018-07-20
Application Number : 208166
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACYCLOVIR
Dosage Strength : 400MG
Approval Date : 2013-11-15
Application Number : 202168
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACYCLOVIR
Dosage Strength : 800MG
Approval Date : 2013-11-15
Application Number : 202168
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Inspections and registrations
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-01-10
City : Pennington
State : NJ
Country/Area : US
Zip : 08534-3601
District : NWJ
Center : CDER
Project Area : Bioresearch Monitoring
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-01-10
District Decision : No Action Indicated
Inspection End Date : 2009-02-06
City : Ahmedabad City
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2009-02-06
District Decision : Voluntary Action Indicated
Inspection End Date : 2009-12-18
City : Vadodara
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2009-12-18
District Decision : Official Action Indicated
Inspection End Date : 2011-02-03
City : Ahmedabad City
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Official Action Indicated
Inspection End Date : 2011-02-03
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-02-04
City : Ankleshwar
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-02-04
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-02-23
City : Ahmedabad City
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-02-23
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-10-04
City : Ahmedabad
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-10-04
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-03-15
City : Vadodara
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-03-15
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-08-19
City : Ahmedabad City
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-08-19
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-09-21
City : Sanand Ahmedabad
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-09-21
ABOUT THIS PAGE
Zydus Lifesciences is a supplier offers 215 products (APIs, Excipients or Intermediates).
Find a price of Mesalazine bulk with DMF, CEP, JDMF offered by Zydus Lifesciences
Find a price of Paroxetine Hydrochloride bulk with DMF, CEP, JDMF offered by Zydus Lifesciences
Find a price of Tramadol Hydrochloride bulk with DMF, CEP, JDMF offered by Zydus Lifesciences
Find a price of Valsartan bulk with CEP, JDMF, WC offered by Zydus Lifesciences
Find a price of Atomoxetin Hydrochloride bulk with DMF, CEP, JDMF offered by Zydus Lifesciences
Find a price of Atorvastatin bulk with DMF, CEP, WC offered by Zydus Lifesciences
Find a price of Losartan Potassium bulk with CEP, JDMF offered by Zydus Lifesciences
Find a price of Amlodipine Besylate bulk with DMF, CEP offered by Zydus Lifesciences
Find a price of Aripiprazole bulk with DMF, CEP offered by Zydus Lifesciences
Find a price of Atenolol bulk with DMF, CEP offered by Zydus Lifesciences
Find a price of Azelastine Hydrochloride bulk with DMF, CEP offered by Zydus Lifesciences
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Find a price of Pitavastatin bulk with DMF, JDMF offered by Zydus Lifesciences
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