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KEY PRODUCTS
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01 1Abemaciclib
02 1Atazanavir Sulfate
03 1Avatrombopag Maleate
04 1Bortezomib
05 1Brinzolamide
06 1Bupropion Hydrochloride
07 1Cabozantinib
08 1Calcium Oxybate
09 1Cetirizine Dihydrochloride
10 1Dapagliflozin
11 2Dasatinib
12 1Dimethyl Fumarate
13 1Diphenhydramine Hydrochloride
14 1Elacestrant
15 1Eltrombopag
16 1Empagliflozin
17 2Esomeprazole Magnesium
18 1Fexofenadine Hydrochloride
19 1Fruquintinib
20 1Gabapentin
21 4Guaifenesin
22 3Ibuprofen
23 1Lapatinib Ditosylate
24 1Levetiracetam
25 3Levocetirizine Dihydrochloride
26 1Linagliptin
27 1Lisdexamfetamine Dimesylate
28 2Losartan Potassium
29 1Magnesium Oxybate
30 13Metformin
31 5Methocarbamol
32 2Metoprolol Succinate
33 1Nilotinib
34 1Olmesartan Medoxomil
35 1Omeprazole
36 1Omeprazole Magnesium
37 1Pantoprazole Sodium
38 9Paracetamol
39 1Pazopanib Hydrochloride
40 1Penicillamine
41 1Pirfenidone
42 1Potassium Chloride
43 1Potassium Oxybate
44 1Prazosin Hydrochloride
45 2Rifaximin
46 1Serdexmethylphenidate Chloride
47 1Sodium Oxybate
48 1Sorafenib
49 1Tenofovir Disoproxil Succinate
50 1Trazodone Hydrochloride
51 1Vigabatrin
52 1Viloxazine Hydrochloride
53 1Blank
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01 47Active
02 42Blank
01 1Valid
02 88Blank
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01 1228MF10061
02 1305MF10066
03 87Blank
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01 3WC-0028
02 4WC-0116
03 2WC-0526
04 80Blank
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01 120050831-37-C-34-05
02 120050831-37-C-34-05(1)
03 120050831-37-C-34-05(10)
04 120050831-37-C-34-05(13)
05 120050831-37-C-34-05(14)
06 120050831-37-C-34-05(2)
07 120050831-37-C-34-05(3)
08 120050831-37-C-34-05(4)
09 120050831-37-C-34-05(5)
10 120050831-37-C-34-05(6)
11 120050831-37-C-34-05(7)
12 120050831-37-C-34-05(9)
13 120050915-32-C-198-10
14 120050915-32-C-198-10(A)
15 120050915-32-C-198-10(B)
16 120080110-81-D-18-01
17 120080110-81-D-18-01(2)
18 120080110-81-D-18-01(3)
19 120080110-81-D-18-01(4)
20 120080110-81-D-18-01(7)
21 120090720-40-C-258-15
22 120090720-40-C-258-15(2)
23 120090720-40-C-258-15(3)
24 120200721-37-C-387-28
25 120210309-211-J-857
26 120210309-211-J-857(1)
27 120210309-211-J-857(2)
28 120210309-211-J-857(3)
29 120250311-209-J-1810
30 120250326-211-J-1822
31 1Su258-50-ND
32 58Blank
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01 162207-001
02 162207-002
03 162207-003
04 162207-004
05 162207-005
06 162207-006
07 162207-007
08 162207-009
09 162207-011
10 262207-012
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12 162207-017
13 162207-018
14 162207-019
15 162207-020
16 162207-021
17 162207-022
18 162207-024
19 162207-025
20 162207-026
21 162207-027
22 162207-100
23 162207-101
24 162207-144
25 162207-200
26 162207-202
27 162207-204
28 162207-300
29 162207-303
30 162207-311
31 162207-400
32 162207-416
33 162207-417
34 162207-500
35 162207-503
36 162207-600
37 162207-702
38 162207-705
39 162207-711
40 162207-714
41 162207-725
42 162207-930
43 162207-931
44 162207-932
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46 162207-934
47 162207-950
48 162207-951
49 162207-952
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51 162207-972
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53 162207-974
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62 162207-984
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66 162207-988
67 162207-989
68 162207-992
69 162207-993
70 162207-994
71 162207-995
72 162207-996
73 16Blank
01 89Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-28
Pay. Date : 2016-07-01
DMF Number : 16625
Submission : 2003-06-06
Status : Active
Type : II
Registration Number : 305MF10066
Registrant's Address : 2nd Floor, 3rd Block My Home Hub, Madhapur, Hyderabad, Telangana 500081 India
Initial Date of Registration : 2023-05-24
Latest Date of Registration :
Date of Issue : 2025-10-07
Valid Till : 2028-07-02
Written Confirmation Number : WC-0028
Address of the Firm :
NDC Package Code : 62207-144
Start Marketing Date : 2021-07-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (97mg/100mg)
Marketing Category : EXPORT ONLY
Registrant Name : Medipoem Co., Ltd.
Registration Date : 2026-04-09
Registration Number : 20050831-37-C-34-05(14)
Manufacturer Name : Granules India Limited
Manufacturer Address : Plot No.: 15A/1, IDA, Phase-Ⅲ, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri District - 500 055 Telangana State, India
| Available Reg. Filing : ASMF, CA, BR, MX |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17722
Submission : 2004-09-22
Status : Active
Type : II
Registration Number : 228MF10061
Registrant's Address : 2nd Floor, 3rd Block, My Home Hub, Madhapur, Hyderabad, Telangana 500081 India
Initial Date of Registration : 2016-02-24
Latest Date of Registration :
Date of Issue : 2025-08-01
Valid Till : 2028-07-02
Written Confirmation Number : WC-0116
Address of the Firm :
NDC Package Code : 62207-934
Start Marketing Date : 2025-04-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Insung Trading Co., Ltd.
Registration Date : 2023-03-29
Registration Number : 20050915-32-C-198-10(B)
Manufacturer Name : Granules India Ltd
Manufacturer Address : H.No.6-5 & 6-11, Temple Road, Bonthapally Village, Gummadidala Mandal, Sangareddy Dist-502313, Telangana State, India.
| Available Reg. Filing : ASMF, CA, MX |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-19
Pay. Date : 2014-03-11
DMF Number : 14372
Submission : 1999-08-30
Status : Active
Type : II
Date of Issue : 2025-10-07
Valid Till : 2028-07-02
Written Confirmation Number : WC-0028
Address of the Firm :
NDC Package Code : 62207-932
Start Marketing Date : 2021-12-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : EXPORT ONLY
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2021-11-30
Registration Number : 20210309-211-J-857(3)
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, Telangana State, India
| Available Reg. Filing : ASMF, BR |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20998
Submission : 2007-10-31
Status : Active
Type : II
Date of Issue : 2025-08-01
Valid Till : 2028-07-02
Written Confirmation Number : WC-0116
Address of the Firm :
NDC Package Code : 62207-500
Start Marketing Date : 2017-08-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (95mg/100mg)
Marketing Category : DRUG FOR FURTHER PRO...
Registrant Name : Daeshin Muyak Co., Ltd.
Registration Date : 2021-07-05
Registration Number : 20210309-211-J-857(2)
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, Telangana State India
| Available Reg. Filing : ASMF, BR |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17723
Submission : 2004-09-22
Status : Active
Type : II
Date of Issue : 2025-08-01
Valid Till : 2028-07-02
Written Confirmation Number : WC-0116
Address of the Firm :
NDC Package Code : 62207-416
Start Marketing Date : 2021-03-25
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (500mg/kg)
Marketing Category : DRUG FOR FURTHER PRO...
Registrant Name : Agerson Bio Co., Ltd.
Registration Date : 2023-01-13
Registration Number : 20050831-37-C-34-05(13)
Manufacturer Name : Granules India Limited
Manufacturer Address : Plot No.: 15A/1, IDA, Phase-Ⅲ, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri District - 500 055 Telangana State, India
| Available Reg. Filing : ASMF, CA, BR, MX |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-28
Pay. Date : 2013-08-12
DMF Number : 17872
Submission : 2004-12-03
Status : Active
Type : II
Date of Issue : 2025-10-07
Valid Till : 2028-07-02
Written Confirmation Number : WC-0028
Address of the Firm :
NDC Package Code : 62207-022
Start Marketing Date : 2024-04-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : EXPORT ONLY
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2012-02-24
Registration Number : 20080110-81-D-18-01(7)
Manufacturer Name : Granules India Limited
Manufacturer Address : Plot No.: 15 A/1, IDA, Phase –III, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri District-500 055, Telangana State, India
| Available Reg. Filing : ASMF, CA, CN |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18978
Submission : 2005-11-28
Status : Active
Type : II
Date of Issue : 2025-08-01
Valid Till : 2028-07-02
Written Confirmation Number : WC-0116
Address of the Firm :
NDC Package Code : 62207-930
Start Marketing Date : 2020-06-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PRO...
Registrant Name : Kenview Korea Sales Co., Ltd.
Registration Date : 2023-03-03
Registration Number : 20050915-32-C-198-10(A)
Manufacturer Name : Granules India Ltd
Manufacturer Address : H.No.6-5 & 6-11, Temple Road, Bonthapally Village, Gummadidala Mandal, Sangareddy Dist-502313, Telangana State, India.
| Available Reg. Filing : ASMF, CA, MX |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36125
Submission : 2021-08-29
Status : Active
Type : II
Certificate Number : CEP 2012-146 - Rev 02
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 2362
Status : Valid
NDC Package Code : 62207-020
Start Marketing Date : 2023-08-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg. Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-13
Pay. Date : 2024-01-08
DMF Number : 39129
Submission : 2023-12-31
Status : Active
Type : II
Date of Issue : 2022-05-02
Valid Till : 2025-05-01
Written Confirmation Number : WC-0526
Address of the Firm :
NDC Package Code : 62207-988
Start Marketing Date : 2024-03-05
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg. Filing : ASMF, CA, BR |
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-05-27
Pay. Date : 2021-04-19
DMF Number : 33544
Submission : 2019-03-27
Status : Active
Type : II
Date of Issue : 2022-05-02
Valid Till : 2025-05-01
Written Confirmation Number : WC-0526
Address of the Firm :
NDC Package Code : 62207-970
Start Marketing Date : 2021-03-25
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg. Filing : ASMF |
Granules India Limited is a supplier offers 63 products (APIs, Excipients or Intermediates).
Find Metformin bulk with DMF, JDMF, WC offered by Granules India Limited
Find Paracetamol bulk with DMF, JDMF, WC offered by Granules India Limited
Find Guaifenesin bulk with DMF, WC offered by Granules India Limited
Find Metformin bulk with DMF, WC offered by Granules India Limited
Find Methocarbamol bulk with DMF, WC offered by Granules India Limited
Find Paracetamol bulk with DMF, WC offered by Granules India Limited
Find Rifaximin bulk with DMF, CEP offered by Granules India Limited
Find Eltrombopag bulk with DMF offered by Granules India Limited
Find Metoprolol Succinate bulk with DMF offered by Granules India Limited
Find Abemaciclib bulk with DMF offered by Granules India Limited
Find Atazanavir Sulfate bulk with DMF offered by Granules India Limited
Find Avatrombopag Maleate bulk with DMF offered by Granules India Limited
Find Bupropion Hydrochloride bulk with DMF offered by Granules India Limited
Find Cetirizine Dihydrochloride bulk with DMF offered by Granules India Limited
Find Dapagliflozin bulk with DMF offered by Granules India Limited
Find Dasatinib bulk with DMF offered by Granules India Limited
Find Dimethyl Fumarate bulk with DMF offered by Granules India Limited
Find Empagliflozin bulk with DMF offered by Granules India Limited
Find Esomeprazole Magnesium bulk with DMF offered by Granules India Limited
Find Fexofenadine Hydrochloride bulk with DMF offered by Granules India Limited
Find Fruquintinib bulk with DMF offered by Granules India Limited
Find Ibuprofen bulk with DMF offered by Granules India Limited
Find Levetiracetam bulk with DMF offered by Granules India Limited
Find Levocetirizine Dihydrochloride bulk with DMF offered by Granules India Limited
Find Linagliptin bulk with DMF offered by Granules India Limited
Find Losartan Potassium bulk with DMF offered by Granules India Limited
Find Nilotinib bulk with DMF offered by Granules India Limited
Find Omeprazole bulk with DMF offered by Granules India Limited
Find Omeprazole Magnesium bulk with DMF offered by Granules India Limited
Find Pantoprazole Sodium bulk with DMF offered by Granules India Limited
Find Paracetamol bulk with DMF offered by Granules India Limited
Find Pazopanib Hydrochloride bulk with DMF offered by Granules India Limited
Find Pirfenidone bulk with DMF offered by Granules India Limited
Find Prazosin Hydrochloride bulk with DMF offered by Granules India Limited
Find Rifaximin bulk with DMF offered by Granules India Limited
Find Serdexmethylphenidate Chloride bulk with DMF offered by Granules India Limited
Find Sorafenib bulk with DMF offered by Granules India Limited
Find Trazodone Hydrochloride bulk with DMF offered by Granules India Limited
Find Vigabatrin bulk with DMF offered by Granules India Limited
Find GABAPENTIN USP bulk with DMF offered by Granules India Limited
Find Bortezomib bulk offered by Granules India Limited
Find Brinzolamide bulk offered by Granules India Limited
Find Cabozantinib bulk offered by Granules India Limited
Find Calcium Oxybate bulk offered by Granules India Limited
Find Diphenhydramine Hydrochloride bulk offered by Granules India Limited
Find Elacestrant bulk offered by Granules India Limited
Find Gabapentin bulk offered by Granules India Limited
Find Guaifenesin bulk offered by Granules India Limited
Find Ibuprofen bulk offered by Granules India Limited
Find Lapatinib Ditosylate bulk offered by Granules India Limited
Find Levocetirizine Dihydrochloride bulk offered by Granules India Limited
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Find Magnesium Oxybate bulk offered by Granules India Limited
Find Metformin bulk offered by Granules India Limited
Find Methocarbamol bulk offered by Granules India Limited
Find Olmesartan Medoxomil bulk offered by Granules India Limited
Find Paracetamol bulk offered by Granules India Limited
Find Penicillamine bulk offered by Granules India Limited
Find Potassium Chloride bulk offered by Granules India Limited
Find Potassium Oxybate bulk offered by Granules India Limited
Find Sodium Oxybate bulk offered by Granules India Limited
Find Tenofovir Disoproxil Succinate bulk offered by Granules India Limited
Find Viloxazine Hydrochloride bulk offered by Granules India Limited