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06 Oct 2025
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-27
Pay. Date : 2012-12-17
DMF Number : 18787
Submission : 2005-09-19
Status : Active
Type : II
Certificate Number : R1-CEP 2006-003 - Rev 04
Issue Date : 2018-04-12
Type : Chemical
Substance Number : 1491
Status : Valid
Registration Number : 218MF10912
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Andhra Pradesh, INDIA
Initial Date of Registration : 2006-11-10
Latest Date of Registration :
Date of Issue : 2025-09-19
Valid Till : 2028-07-03
Written Confirmation Number : WC-0040
Address of the Firm :
Registrant Name : Novartis Korea Co., Ltd.
Registration Date : 2022-10-18
Registration Number : 20120120-130-H-183-36(7)
Manufacturer Name : Hetero Drugs Limited
Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Telangana, India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20246
Submission : 2007-02-07
Status : Active
Type : II
Certificate Number : R1-CEP 2015-128 - Rev 01
Issue Date : 2022-08-29
Type : Chemical
Substance Number : 2640
Status : Valid
Registration Number : 229MF10156
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA
Initial Date of Registration : 2017-08-08
Latest Date of Registration :
Date of Issue : 2025-09-03
Valid Till : 2028-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0021
Start Marketing Date : 2002-11-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Youngjin Pharmaceutical Co., Ltd.
Registration Date : 2024-05-01
Registration Number : Su3838-3-ND(7)
Manufacturer Name : Hetero Labs Limited
Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana, INDIA

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18496
Submission : 2005-07-07
Status : Active
Type : II
Certificate Number : CEP 2012-254 - Rev 03
Issue Date : 2025-04-07
Type : Chemical
Substance Number : 2196
Status : Valid
Registration Number : 226MF10046
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA
Initial Date of Registration : 2014-02-20
Latest Date of Registration :
Date of Issue : 2025-09-03
Valid Till : 2028-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0001
Start Marketing Date : 1995-10-04
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 : Reviewed
Rev. Date : 2013-03-17
Pay. Date : 2013-03-07
DMF Number : 17960
Submission : 2004-12-29
Status : Active
Type : II
Certificate Number : CEP 2017-080 - Rev 06
Issue Date : 2023-10-27
Type : Chemical
Substance Number : 2733
Status : Valid
Registration Number : 303MF10125
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA
Initial Date of Registration : 2021-08-16
Latest Date of Registration :
Date of Issue : 2025-09-03
Valid Till : 2028-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0007
Start Marketing Date : 2002-08-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2025-07-25
Registration Number : 20180604-209-J-223(9)
Manufacturer Name : Hetero Labs Limited
Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-27
Pay. Date : 2016-05-12
DMF Number : 17507
Submission : 2004-07-02
Status : Active
Type : II
Certificate Number : CEP 2017-104 - Rev 04
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 2465
Status : Valid
Registration Number : 228MF10007
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA
Initial Date of Registration : 2016-01-08
Latest Date of Registration :
Date of Issue : 2025-09-03
Valid Till : 2028-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0005
Start Marketing Date : 1997-09-30
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 : Reviewed
Rev. Date : 2012-12-27
Pay. Date : 2012-12-03
DMF Number : 18252
Submission : 2005-04-07
Status : Active
Type : II
Certificate Number : R1-CEP 2008-160 - Rev 02
Issue Date : 2017-08-10
Type : Chemical
Substance Number : 2217
Status : Valid
Registration Number : 229MF10157
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA
Initial Date of Registration : 2017-08-08
Latest Date of Registration :
Date of Issue : 2025-09-03
Valid Till : 2028-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0016
Start Marketing Date : 1995-11-17
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 : Reviewed
Rev. Date : 2012-12-26
Pay. Date : 2012-11-30
DMF Number : 17738
Submission : 2004-10-07
Status : Active
Type : II
Certificate Number : CEP 2014-113 - Rev 02
Issue Date : 2024-11-25
Type : Chemical
Substance Number : 2535
Status : Valid
Registration Number : 302MF10091
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA
Initial Date of Registration : 2020-07-29
Latest Date of Registration :
Date of Issue : 2025-09-03
Valid Till : 2028-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0065
Start Marketing Date : 2006-07-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmawon Co., Ltd.
Registration Date : 2025-05-16
Registration Number : 20120210-183-I-21-19(7)
Manufacturer Name : Hetero Labs Limited
Manufacturer Address : Unit-Ⅰ, Sy.No. 10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-11
Pay. Date : 2012-11-29
DMF Number : 16510
Submission : 2003-03-21
Status : Active
Type : II
Certificate Number : CEP 2016-197 - Rev 02
Issue Date : 2024-07-03
Type : Chemical
Substance Number : 1120
Status : Valid
Registration Number : 222MF10145
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA
Initial Date of Registration : 2010-04-22
Latest Date of Registration :
Date of Issue : 2025-09-19
Valid Till : 2028-07-03
Written Confirmation Number : WC-0040
Address of the Firm :
NDC Package Code : 65977-0009
Start Marketing Date : 1987-12-29
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 : Reviewed
Rev. Date : 2013-04-30
Pay. Date : 2013-04-23
DMF Number : 19988
Submission : 2006-11-22
Status : Active
Type : II
Certificate Number : CEP 2009-247 - Rev 09
Issue Date : 2024-12-02
Type : Chemical
Substance Number : 2232
Status : Valid
Registration Number : 303MF10096
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA
Initial Date of Registration : 2021-06-22
Latest Date of Registration :
Date of Issue : 2025-09-03
Valid Till : 2028-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0008
Start Marketing Date : 1995-04-14
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 : Reviewed
Rev. Date : 2014-01-24
Pay. Date : 2013-12-10
DMF Number : 20591
Submission : 2007-06-11
Status : Active
Type : II
Certificate Number : R1-CEP 2012-215 - Rev 00
Issue Date : 2019-01-29
Type : Chemical
Substance Number : 2258
Status : Valid
Registration Number : 227MF10065
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA
Initial Date of Registration : 2015-03-06
Latest Date of Registration :
Date of Issue : 2025-09-19
Valid Till : 2028-07-03
Written Confirmation Number : WC-0040
Address of the Firm :
NDC Package Code : 65977-0026
Start Marketing Date : 1996-09-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2021-05-18
Registration Number : 20210518-209-J-928
Manufacturer Name : Hetero Drugs Limited Unit I
Manufacturer Address : Survey. No. 213, 214 and 255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Telangana State, India

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-15
Pay. Date : 2013-01-24
DMF Number : 22196
Submission : 2008-11-17
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2016-04-27
Pay. Date : 2015-12-21
DMF Number : 29587
Submission : 2015-07-24
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41395
Submission : 2025-05-22
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2015-03-13
Pay. Date : 2014-12-23
DMF Number : 28383
Submission : 2014-06-13
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-10
DMF Number : 25587
Submission : 2011-12-13
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2017-05-30
Pay. Date : 2017-04-28
DMF Number : 31611
Submission : 2017-04-11
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37111
Submission : 2022-05-07
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39383
Submission : 2024-01-30
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20577
Submission : 2007-06-07
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2021-03-17
Pay. Date : 2020-12-17
DMF Number : 35422
Submission : 2020-12-21
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE
Dosage Strength : EQ 300MG BASE
Approval Date : 2013-09-13
Application Number : 91560
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AA
Dosage Form : SOLUTION; ORAL
Proprietary Name : ABACAVIR SULFATE
Dosage Strength : EQ 20MG BASE/ML
Approval Date : 2016-09-26
Application Number : 201107
RX/OTC/DISCN : RX
RLD : No
TE Code : AA

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE AND LAM...
Dosage Strength : EQ 600MG BASE;300MG
Approval Date : 2025-04-16
Application Number : 205412
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR; LAMIVUDINE
Dosage Strength : 60MG;30MG
Approval Date :
Application Number : 207369
RX/OTC/DISCN :
RLD :
TE Code :

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACYCLOVIR
Dosage Strength : 400MG
Approval Date : 2013-10-29
Application Number : 203834
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACYCLOVIR
Dosage Strength : 800MG
Approval Date : 2013-10-29
Application Number : 203834
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : SUSPENSION; ORAL
Proprietary Name : ACYCLOVIR
Dosage Strength : 200MG/5ML
Approval Date : 2022-07-01
Application Number : 215669
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ALLOPURINOL
Dosage Strength : 100MG
Approval Date : 2023-08-03
Application Number : 217748
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ALLOPURINOL
Dosage Strength : 300MG
Approval Date : 2023-08-03
Application Number : 217748
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Dosage Form : TABLET; ORAL
Proprietary Name : AMLODIPINE AND OLMESARTA...
Dosage Strength : EQ 5MG BASE;20MG
Approval Date : 2025-02-14
Application Number : 209591
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

Inspections and registrations
ABOUT THIS PAGE
Hetero Drugs is a supplier offers 422 products (APIs, Excipients or Intermediates).
Find a price of Amlodipine Besylate bulk with DMF, CEP, JDMF, WC offered by Hetero Drugs
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