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24-26 February, 2026
BIO Partnering at JPMBIO Partnering at JPM
Industry Trade Show
Not Confirmed
12-15 January, 2026
Biotech ShowcaseBiotech Showcase
Industry Trade Show
Not Confirmed
12-14 January, 2026
Digital content

23 Dec 2025
// ECONOMICTIMES
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/aurobindo-arm-to-acquire-additional-20-stake-in-jv-firm/articleshow/126143034.cms

18 Dec 2025
// ECONOMICTIMES
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/usfda-issues-form-483-with-5-observations-to-aurobindo-pharmas-andhra-unit/articleshow/126054187.cms

16 Dec 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213982

10 Dec 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211489

23 Nov 2025
// ECONOMICTIMES
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/aurobindo-pharma-incurring-loss-at-china-plant-hopes-to-achieve-break-even-by-q4/articleshow/125516187.cms

20 Nov 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216536
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-08
Pay. Date : 2012-12-17
DMF Number : 18965
Submission : 2005-11-09
Status : Active
Type : II
Certificate Number : CEP 2006-130 - Rev 05
Issue Date : 2023-11-29
Type : Chemical
Substance Number : 1491
Status : Valid
Registration Number : 226MF10061
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India
Initial Date of Registration : 2014-03-06
Latest Date of Registration :
Date of Issue : 2025-07-11
Valid Till : 2028-07-02
Written Confirmation Number : WC-0120
Address of the Firm :
NDC Package Code : 65862-344
Start Marketing Date : 2023-12-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2017-01-11
Registration Number : 20121113-130-H-244-41(3)
Manufacturer Name : Apitoria Pharma Private Limited Unit-II
Manufacturer Address : Survey No. 10 & 13, IDA, Kazipally, 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 : 2013-02-27
Pay. Date : 2013-01-22
DMF Number : 19308
Submission : 2006-03-27
Status : Active
Type : II
Certificate Number : CEP 2016-219 - Rev 02
Issue Date : 2024-09-26
Type : Chemical
Substance Number : 1615
Status : Valid
Registration Number : 306MF10089
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration :
Date of Issue : 2025-08-08
Valid Till : 2028-06-10
Written Confirmation Number : WC-0017
Address of the Firm :
NDC Package Code : 65862-370
Start Marketing Date : 2023-12-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2025-10-02
Registration Number : 20071025-94-E-50-02(14)
Manufacturer Name : Apitoria Pharma Private Limited, Unit-II
Manufacturer Address : Survey No. : 10 & 13 Gaddapotharam(Village), IDA - Kazipally, 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 : 21934
Submission : 2008-09-02
Status : Active
Type : II
Certificate Number : CEP 2009-316 - Rev 03
Issue Date : 2024-10-30
Type : Chemical
Substance Number : 2366
Status : Valid
Registration Number : 306MF10088
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration :
Date of Issue : 2025-07-11
Valid Till : 2028-06-25
Written Confirmation Number : WC-0023
Address of the Firm :
NDC Package Code : 65862-487
Start Marketing Date : 2024-01-11
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongwoo Chemical Co., Ltd.
Registration Date : 2023-03-15
Registration Number : 20211015-209-J-1014(1)
Manufacturer Name : Apitoria Pharma Private Limited Unit-IV
Manufacturer Address : Sy No's. 52, 53, 58, 59, 61 to 78, 127 & 128, Pydibhimavaram Village & Sy No's. 1, 2, 4 to 9, 11, 29, 30, 31 & 32, Chittivalasa Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh State, India, PIN: 532 409

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-08
Pay. Date : 2012-12-17
DMF Number : 17728
Submission : 2004-09-24
Status : Active
Type : II
Certificate Number : CEP 2005-013 - Rev 06
Issue Date : 2023-11-16
Type : Chemical
Substance Number : 394
Status : Valid
Registration Number : 224MF10214
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Andhra Pradesh, India
Initial Date of Registration : 2012-11-08
Latest Date of Registration :
Date of Issue : 2025-08-08
Valid Till : 2028-06-10
Written Confirmation Number : WC-0017
Address of the Firm :
NDC Package Code : 65862-323
Start Marketing Date : 2023-12-07
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-21
Pay. Date : 2013-09-13
DMF Number : 19908
Submission : 2006-10-26
Status : Active
Type : II
Certificate Number : CEP 2008-010 - Rev 05
Issue Date : 2024-01-05
Type : Chemical
Substance Number : 1756
Status : Valid
Registration Number : 229MF10046
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India
Initial Date of Registration : 2017-02-20
Latest Date of Registration :
Date of Issue : 2025-07-11
Valid Till : 2028-06-25
Written Confirmation Number : WC-0023
Address of the Firm :
NDC Package Code : 65862-266
Start Marketing Date : 2023-12-07
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2025-09-02
Registration Number : 20250902-209-J-2009
Manufacturer Name : Apitoria Pharma Private Limited, Unit-Ⅵ
Manufacturer Address : Plot No: 17, E-Bonangi village, Jawaharlal Nehru Pharma city, Parawada Mandal, Anakapalli District, Pin: 531019; Andhra Pradesh, INDIA.

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-03
Pay. Date : 2014-02-18
DMF Number : 19387
Submission : 2006-04-18
Status : Active
Type : II
Certificate Number : CEP 2010-245 - Rev 04
Issue Date : 2024-01-12
Type : Chemical
Substance Number : 2535
Status : Valid
Registration Number : 306MF10090
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration :
Date of Issue : 2025-07-11
Valid Till : 2028-06-25
Written Confirmation Number : WC-0023
Address of the Firm :
NDC Package Code : 65862-261
Start Marketing Date : 2023-11-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2020-05-11
Registration Number : 20120302-183-I-34-01(4)
Manufacturer Name : Apitoria Pharma Private Limited
Manufacturer Address : Unit-IV, Sy. No's. 52, 53, 58, 59, 61 to 78, 127 & 128, Pydibhimavaram Village & Sy. No's 1, 2, 4 to 9, 11, 29, 30, 31 & 32, Chittivalasa Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India. PIN: 532 409

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-21
Pay. Date : 2013-09-13
DMF Number : 19671
Submission : 2006-08-05
Status : Active
Type : II
Certificate Number : CEP 2009-334 - Rev 06
Issue Date : 2023-12-13
Type : Chemical
Substance Number : 2232
Status : Valid
Registration Number : 224MF10221
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Andhra Pradesh, India
Initial Date of Registration : 2012-11-26
Latest Date of Registration :
Date of Issue : 2025-07-11
Valid Till : 2028-07-02
Written Confirmation Number : WC-0120
Address of the Firm :
NDC Package Code : 65862-428
Start Marketing Date : 2024-01-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2013-01-28
Registration Number : 20100630-122-G-63-23(1)
Manufacturer Name : Aurobindo Pharma Limited
Manufacturer Address : Unit-I, Sy.No. 385, 386, 388 to 396, Borpatla Village, Hatnoora Mandal Medak District, Telangana, India.

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22789
Submission : 2009-05-15
Status : Active
Type : II
Certificate Number : CEP 2009-292 - Rev 03
Issue Date : 2023-11-16
Type : Chemical
Substance Number : 2416
Status : Valid
Registration Number : 223MF10156
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Andhra Pradesh, India
Initial Date of Registration : 2011-11-02
Latest Date of Registration :
Date of Issue : 2025-08-08
Valid Till : 2028-06-10
Written Confirmation Number : WC-0017
Address of the Firm :
NDC Package Code : 65862-506
Start Marketing Date : 2024-01-11
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2025-12-16
Registration Number : 20200107-209-J-314(4)
Manufacturer Name : Apitoria Pharma Private Limited Unit II
Manufacturer Address : Survey No. 10 & 13 Gaddapotharam Village, IDA-Kazipally, Jinnaram Mandal Sangareddy District, Telangana, 502319, India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17435
Submission : 2004-05-31
Status : Active
Type : II
Certificate Number : CEP 2008-019 - Rev 07
Issue Date : 2025-12-19
Type : Chemical
Substance Number : 1705
Status : Valid
Registration Number : 226MF10098
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India
Initial Date of Registration : 2014-05-14
Latest Date of Registration :
Date of Issue : 2025-07-11
Valid Till : 2028-06-25
Written Confirmation Number : WC-0023
Address of the Firm :
NDC Package Code : 65862-222
Start Marketing Date : 2024-01-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Base Farm Co., Ltd.
Registration Date : 2021-04-16
Registration Number : 20050915-39-C-197-06(3)
Manufacturer Name : Apitoria Pharma Private Limited Unit II@Apitoria Pharma Private Limited Unit IV
Manufacturer Address : Survey No. 10 & 13 Gaddapotharam Village, IDA-Kazipally, Jinnaram Mandal Sangareddy District, Telangana, 502319, India@Survey No. 52, 53, 58, 59, 61 to 78, 127 & 128, Pydibhimavaram Village & Survey No. 1, 2, 4 to 9, 11, 29, 30, 31 & 32 Chittivalasa Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh India, 532409

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18192
Submission : 2005-03-11
Status : Active
Type : II
Certificate Number : CEP 2007-146 - Rev 08
Issue Date : 2025-08-11
Type : Chemical
Substance Number : 1734
Status : Valid
Registration Number : 223MF10017
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India
Initial Date of Registration : 2011-02-03
Latest Date of Registration :
Date of Issue : 2025-07-11
Valid Till : 2028-07-02
Written Confirmation Number : WC-0120
Address of the Firm :
NDC Package Code : 65862-364
Start Marketing Date : 2023-11-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-49-A-95-05
Manufacturer Name : Apitoria Pharma Private Limited Unit-I
Manufacturer Address : Unit-I, Sy.No. 379, 385, 386, 388 - 396, Borpatla Village, Hatnoora Mandal, Sangareddy District, Telangana, 502 296 INDIA

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39014
Submission : 2023-11-20
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22830
Submission : 2009-05-27
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40387
Submission : 2024-08-28
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17562
Submission : 2004-07-05
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2013-09-04
Pay. Date : 2013-08-21
DMF Number : 18256
Submission : 2005-03-24
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2024-04-29
Pay. Date : 2024-02-23
DMF Number : 39537
Submission : 2024-03-29
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2022-10-25
Pay. Date : 2022-09-22
DMF Number : 37529
Submission : 2022-09-23
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2022-03-23
Pay. Date : 2022-02-23
DMF Number : 36814
Submission : 2022-02-24
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20031
Submission : 2006-12-04
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20307
Submission : 2007-02-24
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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CEP/COS
Certificate Numbers : CEP 2014-242 - Rev 01
Status : Valid
Issue Date : 2024-01-16
Type : Chemical
Substance Number : 2589

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CEP/COS
Certificate Numbers : CEP 2024-177 - Rev 00
Status : Valid
Issue Date : 2024-07-02
Type : Chemical
Substance Number : 2589

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CEP/COS
Certificate Numbers : CEP 2007-080 - Rev 04
Status : Valid
Issue Date : 2025-09-18
Type : Chemical
Substance Number : 1287

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CEP/COS
Certificate Numbers : CEP 2010-005 - Rev 05
Status : Valid
Issue Date : 2024-09-04
Type : Chemical
Substance Number : 1490

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CEP/COS
Certificate Numbers : CEP 2006-130 - Rev 05
Status : Valid
Issue Date : 2023-11-29
Type : Chemical
Substance Number : 1491

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CEP/COS
Certificate Numbers : CEP 2008-002 - Rev 03
Status : Valid
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 577

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CEP/COS
Certificate Numbers : CEP 2007-147 - Rev 05
Status : Valid
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 260

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Certificate Numbers : CEP 2017-037 - Rev 04
Status : Valid
Issue Date : 2024-09-17
Type : Chemical
Substance Number : 260

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CEP/COS
Certificate Numbers : CEP 2008-001 - Rev 06
Status : Valid
Issue Date : 2024-01-19
Type : Chemical
Substance Number : 578

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CEP/COS
Certificate Numbers : CEP 2007-358 - Rev 05
Status : Valid
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 168

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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Registration Number : 306MF10086
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03

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Registration Number : 306MF10089
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03

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Registration Number : 306MF10087
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03

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Registration Number : 306MF10081
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03

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Registration Number : 306MF10085
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03

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Registration Number : 306MF10090
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03

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Registration Number : 306MF10088
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03

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Registration Number : 306MF10082
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03

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JDMF
Registration Number : 226MF10061
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India
Initial Date of Registration : 2014-03-06
Latest Date of Registration : 2014-03-06

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Registration Number : 223MF10105
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India
Initial Date of Registration : 2011-07-15
Latest Date of Registration : 2011-07-15

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Date of Issue : 2025-07-11
Valid Till : 2028-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy. No\'s. 52,53,58,59,61 to 7...

Date of Issue : 2025-07-11
Valid Till : 2028-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy. No\'s. 52,53,58,59,61 to 7...

Date of Issue : 2025-08-08
Valid Till : 2028-06-10
Written Confirmation Number : WC-0017
Address of the Firm : Unit-II, SurveyNo.:10&13,Gadda...

Date of Issue : 2025-07-11
Valid Till : 2028-07-02
Written Confirmation Number : WC-0120
Address of the Firm : UNIT -I, Sy.Nos. 379, 385, 386...

Date of Issue : 2025-07-11
Valid Till : 2028-07-02
Written Confirmation Number : WC-0120
Address of the Firm : UNIT -I, Sy.Nos. 379, 385, 386...

Date of Issue : 2025-08-08
Valid Till : 2028-06-10
Written Confirmation Number : WC-0017
Address of the Firm : Unit-II, SurveyNo.:10&13,Gadda...

Date of Issue : 2022-12-15
Valid Till : 2025-12-25
Written Confirmation Number : WC-0461
Address of the Firm : Plot no.:17, E-Bonangi Village...

Date of Issue : 2022-08-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0121
Address of the Firm : Plot No. 68-70, 73-91, 95, 96,...

Date of Issue : 2025-07-11
Valid Till : 2028-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy. No\'s. 52,53,58,59,61 to 7...

Date of Issue : 2022-08-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0121
Address of the Firm : Plot No. 68-70, 73-91, 95, 96,...

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Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2021-08-30
Registration Number : 20210323-209-J-897(1)
Manufacturer Name : Apitoria Pharma Private Limite...
Manufacturer Address : Sy No's.52, 53, 58, 59, 61 to 78,127 & 128, Pydibhimavaram Village & Sy. No's. 1, 2, ...

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Registrant Name : Seongwoo Chemical Co., Ltd.
Registration Date : 2021-03-23
Registration Number : 20210323-209-J-897
Manufacturer Name : Apitoria Pharma Private Limite...
Manufacturer Address : Sy No's.52, 53, 58, 59, 61 to 78,127 & 128, Pydibhimavaram Village & Sy. No's. 1, 2, ...

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Registrant Name : Seongwoo Chemical Co., Ltd.
Registration Date : 2019-06-25
Registration Number : 20190625-209-J-376
Manufacturer Name : Apitoria Pharma Private Limite...
Manufacturer Address : Survey No. 10 & 13, IDA, Kazipally, Gaddapotharam Village, Jinnaram Mandal, Sangaredd...

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Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-05-03
Registration Number : 20210503-209-J-965
Manufacturer Name : Apitoria Pharma Private Limite...
Manufacturer Address : Unit-I, Sy.No. 379, 385, 386, 388 - 396, Borpatla Village, Hatnoora Mandal, Sangaredd...

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Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2014-02-07
Registration Number : 20121113-130-H-244-41(2)
Manufacturer Name : Apitoria Pharma Private Limite...
Manufacturer Address : Survey No. 10 & 13 Gaddapotharam Village, IDA-Kazipally, Jinnaram Mandal Sangareddy D...

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Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2013-11-19
Registration Number : 20121113-130-H-244-41(1)
Manufacturer Name : Apitoria Pharma Private Limite...
Manufacturer Address : Unit-II, Sy. No.10&13, Gaddapotharam Village, IDA Kazipally, Jinnaram Mandal, Sangare...

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Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2017-01-11
Registration Number : 20121113-130-H-244-41(3)
Manufacturer Name : Apitoria Pharma Private Limite...
Manufacturer Address : Survey No. 10 & 13, IDA, Kazipally, Gaddapotharam Village, Jinnaram Mandal, Sangaredd...

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Registrant Name : Seongwoo Chemical Co., Ltd.
Registration Date : 2012-11-13
Registration Number : 20121113-130-H-244-41
Manufacturer Name : Apitoria Pharma Private Limite...
Manufacturer Address : Survey No. 10 & 13, IDA, Kazipally, Gaddapotharam Village, Jinnaram Mandal, Sangaredd...

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Registrant Name : Kosha Bio Co., Ltd.
Registration Date : 2018-04-09
Registration Number : 20050915-30-A-168-12(1)
Manufacturer Name : AUROBINDO PHARMA LTD.
Manufacturer Address : Unit-V plot NO. 79-91, Chemical Zone, Pasharmylarm, Medak District, India

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Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2005-09-15
Registration Number : 20050915-30-A-168-12
Manufacturer Name : AUROBINDO PHARMA LTD.
Manufacturer Address : Unit-V plot No. 79-91, Chemical Zone, Pashamylaram, Medak District. India

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC Package Code : 59651-991
Start Marketing Date : 2024-08-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 65862-256
Start Marketing Date : 2024-01-11
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 59651-946
Start Marketing Date : 2024-02-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 59651-708
Start Marketing Date : 2024-01-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 59651-661
Start Marketing Date : 2025-12-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 65862-268
Start Marketing Date : 2024-01-11
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 65862-206
Start Marketing Date : 2023-12-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 65862-344
Start Marketing Date : 2023-12-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 59651-099
Start Marketing Date : 2024-01-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 65862-274
Start Marketing Date : 2024-01-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT







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About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operation...

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About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operation...

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About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operation...

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About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operation...

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About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operation...

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About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operation...

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About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operation...

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About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operation...

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About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operation...

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About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operation...

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Details:
Zentiva holds a broad portfolio of generic and biosimilar products, including Affenid XL (methylphenidate hydrochloride) for the treatment of Attention-Deficit/Hyperactivity Disorder.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Affenid XL
Study Phase: Approved FDFProduct Type: Miscellaneous
Recipient: Zentiva
Deal Size: $5,500.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition August 20, 2025

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Lead Product(s) : Methylphenidate Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Recipient : Zentiva
Deal Size : $5,500.0 million
Deal Type : Acquisition
Aurobindo Pharma closing in on $5.5b Zentiva buyout
Details : Zentiva holds a broad portfolio of generic and biosimilar products, including Affenid XL (methylphenidate hydrochloride) for the treatment of Attention-Deficit/Hyperactivity Disorder.
Product Name : Affenid XL
Product Type : Miscellaneous
Upfront Cash : Undisclosed
August 20, 2025

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Details:
Sprycel-Generic (dasatinib) is an inhibitor of multiple tyrosine kinases, which is indicated for the treatment of in certain types of cancer of bone marroe and blood.
Lead Product(s): Dasatinib
Therapeutic Area: Oncology Brand Name: Sprycel-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Recipient: Eugia Pharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 23, 2025

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Lead Product(s) : Dasatinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Recipient : Eugia Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurobindo Pharma Arm gets USFDA Nod for Generic Blood Cancer Drug
Details : Sprycel-Generic (dasatinib) is an inhibitor of multiple tyrosine kinases, which is indicated for the treatment of in certain types of cancer of bone marroe and blood.
Product Name : Sprycel-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 23, 2025

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Rivaroxaban is an oral factor Xa inhibitor, which is indicated for prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Lead Product(s): Rivaroxaban
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Xarelto-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 14, 2025

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Lead Product(s) : Rivaroxaban
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg
Details : Rivaroxaban is an oral factor Xa inhibitor, which is indicated for prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Product Name : Xarelto-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 14, 2025

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Votrient-Generic (pazopanib HCl) is a multi-kinase inhibitor, which is indicated for the treatment of adults with advanced renal cell carcinoma & advanced soft tissue sarcoma.
Lead Product(s): Pazopanib Hydrochloride
Therapeutic Area: Oncology Brand Name: Votrient-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 05, 2024

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Lead Product(s) : Pazopanib Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Eugia Pharma Receives USFDA Approval for Pazopanib Tablets, 200 mg
Details : Votrient-Generic (pazopanib HCl) is a multi-kinase inhibitor, which is indicated for the treatment of adults with advanced renal cell carcinoma & advanced soft tissue sarcoma.
Product Name : Votrient-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 05, 2024

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Vorient-Generic (pazopanib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma & advanced soft tissue sarcoma who have received prior chemotherapy.
Lead Product(s): Pazopanib Hydrochloride
Therapeutic Area: Oncology Brand Name: Vorient-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 05, 2024

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Lead Product(s) : Pazopanib Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Auro Pharma Arm Gets USFDA Nod for Pazopanib Tablet
Details : Vorient-Generic (pazopanib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma & advanced soft tissue sarcoma who have received prior chemotherapy.
Product Name : Vorient-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 05, 2024

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Details:
Lidocaine is a local anesthetic that's used to numb areas of the body before medical procedures, treat pain, and treat certain heart conditions.
Lead Product(s): Lidocaine Hydrochloride
Therapeutic Area: Neurology Brand Name: Lidocaine HCl-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 11, 2024

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Lead Product(s) : Lidocaine Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Eugia Steriles Receives FDA Approval for New Injectables Facility
Details : Lidocaine is a local anesthetic that's used to numb areas of the body before medical procedures, treat pain, and treat certain heart conditions.
Product Name : Lidocaine HCl-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 11, 2024

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Vagifem-Generic (estradiol) is a USFDA approved steroid hormone which is indicated for the treatment of patients with atrophic vaginitis due to menopause.
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Vagifem-Generic
Study Phase: Approved FDFProduct Type: Hormone
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 07, 2024

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Lead Product(s) : Estradiol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurobindo Gets USFDA Nod for Generic Version of Novo Nordisk's Vagifem
Details : Vagifem-Generic (estradiol) is a USFDA approved steroid hormone which is indicated for the treatment of patients with atrophic vaginitis due to menopause.
Product Name : Vagifem-Generic
Product Type : Hormone
Upfront Cash : Inapplicable
August 07, 2024

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Nasonex-Generic (mometasone furoate monohydrate) nasal spray, a corticosteroid, has received FDA approval for treating allergic rhinitis symptoms.
Lead Product(s): Mometasone Furoate
Therapeutic Area: Immunology Brand Name: Nasonex-Generic
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 19, 2024

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Lead Product(s) : Mometasone Furoate
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurobindo Receives USFDA Approval for Mometasone Furoate Nasal Spray
Details : Nasonex-Generic (mometasone furoate monohydrate) nasal spray, a corticosteroid, has received FDA approval for treating allergic rhinitis symptoms.
Product Name : Nasonex-Generic
Product Type : Steroid
Upfront Cash : Inapplicable
March 19, 2024

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Details:
Emflaza (deflazacort), a corticosteroid prodrug whose active metabolite acts as a glucocorticoid receptor agonist. It is approved for treating duchenne muscular dystrophy in patients 5 years & older.
Lead Product(s): Deflazacort
Therapeutic Area: Genetic Disease Brand Name: Emflaza
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 12, 2024

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Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurobindo Pharma Receives USFDA Approval for Deflazacort Tablets in Multiple Strengths
Details : Emflaza (deflazacort), a corticosteroid prodrug whose active metabolite acts as a glucocorticoid receptor agonist. It is approved for treating duchenne muscular dystrophy in patients 5 years & older.
Product Name : Emflaza
Product Type : Steroid
Upfront Cash : Inapplicable
February 12, 2024

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Noxafil-Generic (posaconazole) is an azole antifungal agent. It is approved for the treatment of prophylaxis of invasive Aspergillus and Candida infections.
Lead Product(s): Posaconazole
Therapeutic Area: Infections and Infectious Diseases Brand Name: Noxafil-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 27, 2023

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Lead Product(s) : Posaconazole
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurobindo Pharma Gets USFDA Nod for Generic Antifungal Injection
Details : Noxafil-Generic (posaconazole) is an azole antifungal agent. It is approved for the treatment of prophylaxis of invasive Aspergillus and Candida infections.
Product Name : Noxafil-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 27, 2023

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Regulatory Info : Generic
Registration Country : South Africa
Dosage Form : FCT
Brand Name : AURO ABACAVIR LAMIVUDINE ...
Dosage Strength : 600mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : TABLET
Brand Name : AURO-ABACAVIR/LAMIVUDINE
Dosage Strength : 600MG
Packaging : 30/60/90
Approval Date :
Application Number : 2454513
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info :
Registration Country : USA
Dosage Form : TABLET; ORAL
Brand Name : ABACAVIR SULFATE
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number : 22293
Regulatory Info :
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ABACAVIR SULFATE
Dosage Strength : EQ 300MG BASE
Packaging :
Approval Date : 2012-12-17
Application Number : 77844
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;ORAL
Brand Name : ABACAVIR SULFATE
Dosage Strength : EQ 20MG BASE/ML
Packaging :
Approval Date : 2018-03-14
Application Number : 77950
Regulatory Info : RX
Registration Country : USA

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Regulatory Info :
Registration Country : USA
Dosage Form : TABLET; ORAL
Brand Name : ABACAVIR SULFATE; LAMIVUD...
Dosage Strength : 60MG; 30MG
Packaging :
Approval Date :
Application Number : 22295
Regulatory Info :
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ABACAVIR SULFATE AND LAMI...
Dosage Strength : EQ 600MG BASE;300MG
Packaging :
Approval Date : 2018-11-15
Application Number : 90159
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ABACAVIR SULFATE AND LAMI...
Dosage Strength : EQ 600MG BASE;300MG
Packaging :
Approval Date : 2017-03-28
Application Number : 206151
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : Generic
Registration Country : South Africa
Dosage Form : TAB
Brand Name : Bavir Tablets 300 mg
Dosage Strength : 300mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Dosage Form : SOL
Brand Name : Bavir Oral Solution 20 mg...
Dosage Strength : 20mg/ml
Packaging : 240X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE
Dosage Strength : 60MG
Approval Date :
Application Number : 22293
RX/OTC/DISCN :
RLD :
TE Code :

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE
Dosage Strength : EQ 300MG BASE
Approval Date : 2012-12-17
Application Number : 77844
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 : 2018-03-14
Application Number : 77950
RX/OTC/DISCN : RX
RLD : No
TE Code : AA

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RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE; LAMIVU...
Dosage Strength : 60MG; 30MG
Approval Date :
Application Number : 22295
RX/OTC/DISCN :
RLD :
TE Code :

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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 : 2018-11-15
Application Number : 90159
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE AND LAM...
Dosage Strength : EQ 600MG BASE;300MG
Approval Date : 2017-03-28
Application Number : 206151
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD :
TE Code :
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR; DOLUTEGRAVIR; ...
Dosage Strength : 60MG;5MG;30MG
Approval Date :
Application Number : 217070
RX/OTC/DISCN :
RLD :
TE Code :

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RLD : No
TE Code :
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : ACETAMINOPHEN
Dosage Strength : 650MG
Approval Date : 2016-11-09
Application Number : 207229
RX/OTC/DISCN : OTC
RLD : No
TE Code :

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RLD : No
TE Code : AP1
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : ACETAMINOPHEN
Dosage Strength : 1GM/100ML (10MG/ML)
Approval Date : 2020-10-21
Application Number : 210969
RX/OTC/DISCN : RX
RLD : No
TE Code : AP1

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RLD : No
TE Code :
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN, ASPIRIN A...
Dosage Strength : 250MG;250MG;65MG
Approval Date : 2022-02-02
Application Number : 211695
RX/OTC/DISCN : OTC
RLD : No
TE Code :

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Regulatory Info :
Registration Country : Italy
Dosage Form : Tablets
Dosage Strength : 50 mg
Packaging : 40 UNITS 50 MG - O...
Brand Name : ACARBOSE AUROBINDO
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info :
Registration Country : Italy
Dosage Form : Gastro-Resistant Tablets
Dosage Strength : 100 mg
Packaging : 30 UNITS 100 MG - ...
Brand Name : AUROBINDO ACETYLSALICYLIC ACI...
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Tablet
Dosage Strength : 100mg
Packaging :
Brand Name : Acetylsalicylic Acid Aurobind...
Approval Date : 2020-08-17
Application Number : 20190815000013
Regulatory Info : Deregistered
Registration Country : Sweden

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Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Tablet
Dosage Strength : 75mg
Packaging :
Brand Name : Acetylsalicylic Acid Aurobind...
Approval Date : 2023-08-24
Application Number : 20220801000199
Regulatory Info : Deregistered
Registration Country : Sweden

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Regulatory Info :
Registration Country : Italy
Dosage Form : Acitretin 10Mg 30 Joined' Oral...
Dosage Strength : 30 cps 10 mg
Packaging :
Brand Name : Neotigason
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info :
Registration Country : Italy
Dosage Form : Acitretin 25Mg 20 Joined' Oral...
Dosage Strength : 20 cps 25 mg
Packaging :
Brand Name : Neotigason
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info :
Registration Country : Italy
Dosage Form : Hard Capsules
Dosage Strength : 25 mg
Packaging : 20 UNITS 25 MG - O...
Brand Name : NEOTIGASON
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info :
Registration Country : Italy
Dosage Form : Hard Capsules
Dosage Strength : 10 mg
Packaging : 30 UNITS 10 MG - O...
Brand Name : NEOTIGASON
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info :
Registration Country : Italy
Dosage Form : Oral Suspension
Dosage Strength : 400 mg/5 ml
Packaging : 100 ML 8% - ORAL U...
Brand Name : ACICLOVIR AUROBINDO
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info : Cancelled
Registration Country : Spain
Dosage Form : Tablet
Dosage Strength : 200MG
Packaging :
Brand Name : Aciclovir Aurobindo
Approval Date : 2019-06-28
Application Number : 84298
Regulatory Info : Cancelled
Registration Country : Spain

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Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : TABLET
Dosage Strength : 600MG
Packaging : 30/60/90
Brand Name : AURO-ABACAVIR/LAMIVUDINE
Approval Date :
Application Number : 2454513
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : NARCOTICS (CDSA I)
Registration Country : Canada
Dosage Form : TABLET
Dosage Strength : 325MG
Packaging : 100
Brand Name : AURO-TRAMADOL/ACETAMINOPHEN
Approval Date :
Application Number : 2439050
Regulatory Info : NARCOTICS (CDSA I)
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Dosage Strength : 50MG/ML
Packaging :
Brand Name : ACYCLOVIR SODIUM INJECTION
Approval Date :
Application Number : 2494558
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Dosage Strength : 50MG/ML
Packaging :
Brand Name : ACYCLOVIR SODIUM INJECTION
Approval Date :
Application Number : 2531224
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
ALENDRONIC ACID (ALENDRONATE SODIUM)
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging : 4/30/100/500/1000
Brand Name : AURO-ALENDRONATE
Approval Date :
Application Number : 2388545
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
ALENDRONIC ACID (ALENDRONATE SODIUM)
Dosage Form : TABLET
Dosage Strength : 70MG
Packaging : 4/30/100/500/1000
Brand Name : AURO-ALENDRONATE
Approval Date :
Application Number : 2388553
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : TABLET (EXTENDED-RELEASE)
Dosage Strength : 10MG
Packaging :
Brand Name : AURO-ALFUZOSIN
Approval Date :
Application Number : 2443201
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
AMLODIPINE (AMLODIPINE BESYLATE)
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging : 100/250
Brand Name : AURO-AMLODIPINE
Approval Date :
Application Number : 2397072
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
AMLODIPINE (AMLODIPINE BESYLATE)
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging : 100/250
Brand Name : AURO-AMLODIPINE
Approval Date :
Application Number : 2397080
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
AMOXICILLIN (AMOXICILLIN TRIHYDRATE)
Dosage Form : CAPSULE
Dosage Strength : 250MG
Packaging : 30/100/500
Brand Name : AURO-AMOXICILLIN
Approval Date :
Application Number : 2388073
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info :
Registration Country : Australia
Dosage Form : injection
Dosage Strength : 100 mg
Packaging : 1
Brand Name : AZACITIDINE EUGIA
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia

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Regulatory Info :
Registration Country : Australia
Dosage Form : injection
Dosage Strength : 100 mg
Packaging : 1
Brand Name : AZACITIDINE EUGIA
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia

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Regulatory Info :
Registration Country : Australia
Dosage Form : injection
Dosage Strength : 100 mg
Packaging : 1
Brand Name : AZACITIDINE EUGIA
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia

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Regulatory Info :
Registration Country : Australia
Dosage Form : injection
Dosage Strength : 100 mg
Packaging : 1
Brand Name : AZACITIDINE EUGIA
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia

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Regulatory Info :
Registration Country : Australia
Dosage Form : injection
Dosage Strength : 100 mg
Packaging : 1
Brand Name : AZACITIDINE EUGIA
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia

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Regulatory Info :
Registration Country : Australia
Dosage Form : injection
Dosage Strength : 100 mg
Packaging : 1
Brand Name : AZACITIDINE EUGIA
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia

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Regulatory Info :
Registration Country : Australia
Dosage Form : injection
Dosage Strength : 100 mg
Packaging : 1
Brand Name : AZACITIDINE EUGIA
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia

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Regulatory Info :
Registration Country : Australia
Dosage Form : injection
Dosage Strength : 100 mg
Packaging : 1
Brand Name : AZACITIDINE EUGIA
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia

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Regulatory Info :
Registration Country : Australia
Dosage Form : injection
Dosage Strength : 100 mg
Packaging : 1
Brand Name : AZACITIDINE EUGIA
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia

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Regulatory Info :
Registration Country : Australia
Dosage Form : injection
Dosage Strength : 100 mg
Packaging : 1
Brand Name : AZACITIDINE EUGIA
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia

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Regulatory Info : Generic
Registration Country : South Africa
Dosage Form : FCT
Dosage Strength : 600mg
Packaging : 30X1mg
Brand Name : AURO ABACAVIR LAMIVUDINE 600/...
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Dosage Form : TAB
Dosage Strength : 300mg
Packaging : 60X1mg
Brand Name : Bavir Tablets 300 mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Dosage Form : SOL
Dosage Strength : 20mg/ml
Packaging : 240X1mg/ml
Brand Name : Bavir Oral Solution 20 mg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Dosage Form : CAP
Dosage Strength : 250mg
Packaging : 500X1mg
Brand Name : Auro-Amoxycillin Capsules 250...
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Dosage Form : CAP
Dosage Strength : 500mg
Packaging : 100X1mg
Brand Name : Auro-Amoxycillin Capsules 500...
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Dosage Form : CAP
Dosage Strength : 200mg
Packaging : 60X1mg
Brand Name : Zorovir 200mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Dosage Form : CAP
Dosage Strength : 300mg
Packaging : 30X1mg
Brand Name : Zorovir 300mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Dosage Form : TAB
Dosage Strength : 16mg
Packaging : 30X1mg
Brand Name : Hidrist 16 mg Tablets
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Dosage Form : TAB
Dosage Strength : 24mg
Packaging : 20X1mg
Brand Name : Dahide 24 mg Tablets
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Dosage Form : TAB
Dosage Strength : 1000mg
Packaging : 20X1mg
Brand Name : Auro-Cefalexin 1000mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info :
Registration Country : India
Acetaminophen/Paracetamol; Chlorpheniramine Maleate; Phenylephrine Hydrochloride; Caffeine
Dosage Form : Tablet
Brand Name :
Dosage Strength : 500MG; 4MG; 5MG; 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info :
Registration Country : India
Dosage Form : Tablet
Brand Name :
Dosage Strength : 70MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info :
Registration Country : India
Dosage Form : SR Tablet
Brand Name :
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info :
Registration Country : India
Dosage Form : Tablet
Brand Name :
Dosage Strength : 2.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info :
Registration Country : India
Dosage Form : Tablet
Brand Name :
Dosage Strength : 0.25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info :
Registration Country : India
Dosage Form : Tablet
Brand Name :
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info :
Registration Country : India
Dosage Form : Tablet
Brand Name :
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info :
Registration Country : India
Dosage Form : Tablet
Brand Name :
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info :
Registration Country : India
Dosage Form : Tablet
Brand Name :
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info :
Registration Country : India
Dosage Form : Capsule
Brand Name :
Dosage Strength : 5MG; 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients
NDC Package Code : 59651-876
Start Marketing Date : 2024-04-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER, FOR SOLUTION (17g/17g)
Marketing Category : DRUG FOR FURTHER PRO...

Excipients Web Link
Inspections and registrations
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-09-01
City : Hyderabad
State :
Country/Area : India
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-09-01

District Decision : Voluntary Action Indicated
Inspection End Date : 2017-04-18
City : Bachupally
State :
Country/Area : India
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-04-18

District Decision : No Action Indicated
Inspection End Date : 2017-02-21
City : Pydibhimavaram
State :
Country/Area : India
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2017-02-21

District Decision : No Action Indicated
Inspection End Date : 2015-07-09
City : Dayton
State : NJ
Country/Area : U.S.A
Zip : 08810-1519
District : NWJ
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2015-07-09

District Decision : Voluntary Action Indicated
Inspection End Date : 2015-06-26
City : Hyderabad
State :
Country/Area : India
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-06-26

District Decision : No Action Indicated
Inspection End Date : 2014-12-12
City : Dayton
State : NJ
Country/Area : U.S.A
Zip : 8810
District : NWJ
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-12-12

District Decision : No Action Indicated
Inspection End Date : 2014-12-09
City : Hyderabad
State :
Country/Area : India
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-12-09

District Decision : Voluntary Action Indicated
Inspection End Date : 2014-09-26
City : Medak District, Hyderabad
State :
Country/Area : India
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-09-26

District Decision : Voluntary Action Indicated
Inspection End Date : 2014-04-19
City : Medak
State :
Country/Area : India
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-04-19

District Decision : No Action Indicated
Inspection End Date : 2013-11-22
City : Hyderabad (Medak District...
State :
Country/Area : India
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2013-11-22

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Type : GMP Certificates
Number : NL/H 15/100...
EudraGMDP Key : 33286
Country : Netherlands
Issue Date :
Post Code : 3335LH
NCA Ref : FUSY/34611
City : ZWIJNDRECHT

Auronext Pharma Private Limited
Type : GMP Certificates
Number : FT020/MH/00...
EudraGMDP Key : 28286
Country : India
Issue Date :
Post Code : 301 019
NCA Ref : 2.8286141112...
City : Rajasthan

Auronext Pharma Private Limited
Type : GMP Certificates
Number : FT020/SA/00...
EudraGMDP Key : 28251
Country : India
Issue Date :
Post Code : 301019
NCA Ref : 2.8251141112...
City : Rajasthan

Type : GMP Certificates
Number : FI035/MH/00...
EudraGMDP Key : 16446
Country : India
Issue Date :
Post Code : Andhra Pradesh
NCA Ref : 1.6446136878...
City : Bachupally Village, Qut...

Type : GMP Certificates
Number : FI036/MH/00...
EudraGMDP Key : 25780
Country : India
Issue Date :
Post Code : Andhra Pradesh
NCA Ref : 2.578013993e...
City : Sangareddy Mandal Medak...

Type : GMP Certificates
Number : 3166/12.01....
EudraGMDP Key : 11797
Country : India
Issue Date :
Post Code : 502307
NCA Ref : Aurobindo Un...
City : Andhra Pradesh

Type : GMP Certificates
Number : 3169/12.01....
EudraGMDP Key : 14589
Country : India
Issue Date :
Post Code : Pin code 500 090
NCA Ref : Aurobindo Un...
City : Hyderabad

Type : GMP Certificates
Number : 2984/12.01....
EudraGMDP Key : 18094
Country : India
Issue Date :
Post Code : 502319
NCA Ref : 1.8094138069...
City : Medak District

Type : GMP Certificates
Number : UK GMP 1927...
EudraGMDP Key : 10847
Country : India
Issue Date :
Post Code : IN-502307
NCA Ref : 1449737-AURO...
City : PATANCHERU MANDAL

Type : GMP Certificates
Number : FI07/02/201...
EudraGMDP Key : 16446
Country : India
Issue Date :
Post Code : Andhra Pradesh
NCA Ref : 1.6446136878...
City : Bachupally Village, Qut...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Name and address of WHO GMP certified Manufacturer : Aurobindo Pharma Ltd., Unit-XI, Sy.No.1/22, 2/1, to 5, 6, to 18, 61 to 69, Pydibhimavaram (V), Ranasthalam (M), Srikakulam District.
Country : India

Name and address of WHO GMP certified Manufacturer : Aurobindo Pharma Ltd., Unit-XI, Sy.No.1/22, 2/1, to 5, 6, to 18, 61 to 69, Pydibhimavaram (V), Ranasthalam (M), Srikakulam District.
Country : India

Name and address of WHO GMP certified Manufacturer : Aurobindo Pharma Ltd, Unit-IV, Plot.No.4, 34 to 48, EPIP Pashamylaram, Medak
Country : India

Name and address of WHO GMP certified Manufacturer : Aurobindo Pharma Ltd, Unit-VII, APIIC, Plot.No.SI, Sy.No.411, 425, 434, 435&458, Green Industrial Park, Polepally Village, Jedcherla Mandal, MBNR.Dist.
Country : India

Name and address of WHO GMP certified Manufacturer : Aurobindo Pharma LTD. Unit-III,Survey No.313&314,Bachupally(v)Qutubullapur (m)R.R District
Country : India

Name and address of WHO GMP certified Manufacturer : Aurobindo Pharma LTD. Unit-XII,Survey No.314,Bachupally(v)Qutubullapur (m)R.R District
Country : India

Name and address of WHO GMP certified Manufacturer : Auronext PharmaPvt. Ltd., A-1128, RIICO Industrial area, Phase-III, Bhiwadi.
Country : India

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : AUROBINDO PHARMA LIMITED
Business Address : Unit-I, Survey No. 379, 385,...
FEI Number : 3004021253
Country : India
Paid in : 2019

API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Aurobindo Pharma Limited
Business Address : Unit-VI, Sy. No.329/39 & 329...
FEI Number : 3004021263
Country : India
Paid in : 2019

API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : AUROBINDO PHARMA LIMITED
Business Address : Unit-V, Plot No. 68-70, 73-9...
FEI Number : 3004051616
Country : India
Paid in : 2019

API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Aurobindo Pharma Limited
Business Address : Unit-VII, Sy.No.411/P, 425/P...
FEI Number : 3007373532
Country : India
Paid in : 2019

API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : AUROBINDO PHARMA LIMITED
Business Address : Unit-VIII, Survey No. 10 & 1...
FEI Number : 3004086884
Country : India
Paid in : 2019

API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Aurobindo Pharma Limited
Business Address : Unit-XII, Sy.No.314, Bachupa...
FEI Number : 3004446312
Country : India
Paid in : 2019

API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : AUROBINDO PHARMA LIMITED
Business Address : Unit-IX, Survey No. 374, Gun...
FEI Number : 3006370489
Country : India
Paid in : 2019

API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Aurobindo Pharma Limited
Business Address : Unit-XVI, Plot No: S-5/B, S-...
FEI Number : 3011905047
Country : India
Paid in : 2019

API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Aurobindo Pharma Limited
Business Address : Unit-III, Sy. No.313 & 314, ...
FEI Number : 3004021229
Country : India
Paid in : 2019

API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Aurobindo Pharma Limited
Business Address : Unit-X, Plot No.16, APIIC Mu...
FEI Number : 3011895410
Country : India
Paid in : 2019

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Country : India
City/Region : Gaddapotharam Village
Audit Date : 2025-05-08
Audit Type : On-Site
Country : India
City/Region : Telangana
Audit Date : 2025-03-19
Audit Type : On-Site
Country : India
City/Region : Borpatla Village
Audit Date : 2023-11-23
Audit Type : On-Site
Country : India
City/Region : Borpatla Village
Audit Date : 2023-11-21
Audit Type : On-Site
Country : India
City/Region : Pydibhimavaram Village
Audit Date : 2023-07-21
Audit Type : On-Site
Country : India
City/Region : Hatnoora
Audit Date : 2023-07-11
Audit Type : On-Site
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
AUROBINDO PHARMA LIMITED (UNIT VI) is a supplier offers 477 products (APIs, Excipients or Intermediates).
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