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22 Dec 2025
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12 Dec 2025
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Latest Content by PharmaCompass
KEY PRODUCTS
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01 1Atazanavir Sulfate
02 1Avatrombopag Maleate
03 1Bortezomib
04 1Brinzolamide
05 1Bupropion Hydrochloride
06 1Cabozantinib
07 1Calcium Oxybate
08 1Cetirizine Dihydrochloride
09 1Dapagliflozin
10 2Dasatinib
11 1Dimethyl Fumarate
12 1Diphenhydramine Hydrochloride
13 1Elacestrant
14 1Eltrombopag
15 1Empagliflozin
16 2Esomeprazole Magnesium
17 1Fexofenadine Hydrochloride
18 1Gabapentin
19 4Guaifenesin
20 3Ibuprofen
21 1Lapatinib Ditosylate
22 1Levetiracetam
23 3Levocetirizine Dihydrochloride
24 1Linagliptin
25 1Lisdexamfetamine Dimesylate
26 2Losartan Potassium
27 1Magnesium Oxybate
28 12Metformin
29 5Methocarbamol
30 2Metoprolol Succinate
31 1Nilotinib
32 1Olmesartan Medoxomil
33 1Omeprazole
34 1Omeprazole Magnesium
35 1Pantoprazole Sodium
36 9Paracetamol
37 1Pazopanib Hydrochloride
38 1Penicillamine
39 1Pirfenidone
40 1Potassium Chloride
41 1Prazosin Hydrochloride
42 2Rifaximin
43 2Ruxolitinib Phosphate
44 1Sorafenib
45 1Tenofovir Disoproxil Succinate
46 1Trazodone Hydrochloride
47 1Vigabatrin
48 1Viloxazine Hydrochloride
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01 43Active
02 41Blank
01 2Valid
02 82Blank
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01 1228MF10061
02 1305MF10066
03 82Blank
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01 3WC-0028
02 4WC-0116
03 2WC-0526
04 75Blank
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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(2)
06 120050831-37-C-34-05(3)
07 120050831-37-C-34-05(4)
08 120050831-37-C-34-05(5)
09 120050831-37-C-34-05(6)
10 120050831-37-C-34-05(7)
11 120050831-37-C-34-05(9)
12 120050915-32-C-198-10
13 120050915-32-C-198-10(A)
14 120050915-32-C-198-10(B)
15 120080110-81-D-18-01
16 120080110-81-D-18-01(2)
17 120080110-81-D-18-01(3)
18 120080110-81-D-18-01(4)
19 120080110-81-D-18-01(7)
20 120090720-40-C-258-15
21 120090720-40-C-258-15(2)
22 120090720-40-C-258-15(3)
23 120100616-122-G-58-21
24 120100616-122-G-58-21(1)
25 120200721-37-C-387-28
26 120210309-211-J-857
27 120210309-211-J-857(1)
28 120210309-211-J-857(2)
29 120210309-211-J-857(3)
30 120250311-209-J-1810
31 120250326-211-J-1822
32 53Blank
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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
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15 162207-020
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17 162207-022
18 162207-024
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20 162207-026
21 162207-100
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23 162207-144
24 162207-200
25 162207-202
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27 162207-300
28 162207-303
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30 162207-400
31 162207-416
32 162207-417
33 162207-500
34 162207-503
35 162207-600
36 162207-702
37 162207-705
38 162207-711
39 162207-714
40 162207-725
41 162207-930
42 162207-931
43 162207-932
44 162207-933
45 162207-934
46 162207-950
47 162207-951
48 162207-952
49 162207-970
50 162207-972
51 162207-973
52 162207-974
53 162207-975
54 162207-976
55 162207-977
56 162207-979
57 162207-980
58 162207-981
59 162207-982
60 162207-983
61 162207-984
62 162207-985
63 162207-986
64 162207-987
65 162207-988
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71 13Blank
01 84Blank
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 : 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 : 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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 32259
Submission : 2017-12-27
Status : Active
Type : II
Certificate Number : CEP 2020-279 - Rev 01
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 2898
Status : Valid
NDC Package Code : 62207-005
Start Marketing Date : 2018-06-11
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : DRUG FOR FURTHER PRO...
| Available Reg. Filing : ASMF, 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 Pharmaceutical 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 : Farm East Co., Ltd.
Registration Date : 2021-10-20
Registration Number : 20050831-37-C-34-05(10)
Manufacturer Name : M/s Granules India Limited
Manufacturer Address : Plot No.: 15A/1, Phase-Ⅲ, IDA, Jeedimetla, Quthbullapur (M), 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 : Johnson & Johnson 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 |
Granules India Limited is a supplier offers 58 products (APIs, Excipients or Intermediates).
Find a price of Metformin bulk with DMF, JDMF, WC offered by Granules India Limited
Find a price of Paracetamol bulk with DMF, JDMF, WC offered by Granules India Limited
Find a price of Atazanavir Sulfate bulk with DMF, CEP offered by Granules India Limited
Find a price of Guaifenesin bulk with DMF, WC offered by Granules India Limited
Find a price of Metformin bulk with DMF, WC offered by Granules India Limited
Find a price of Methocarbamol bulk with DMF, WC offered by Granules India Limited
Find a price of Paracetamol bulk with DMF, WC offered by Granules India Limited
Find a price of Rifaximin bulk with DMF, CEP offered by Granules India Limited
Find a price of Eltrombopag bulk with DMF offered by Granules India Limited
Find a price of Metoprolol Succinate bulk with DMF offered by Granules India Limited
Find a price of Avatrombopag Maleate bulk with DMF offered by Granules India Limited
Find a price of Bupropion Hydrochloride bulk with DMF offered by Granules India Limited
Find a price of Cetirizine Dihydrochloride bulk with DMF offered by Granules India Limited
Find a price of Dapagliflozin bulk with DMF offered by Granules India Limited
Find a price of Dasatinib bulk with DMF offered by Granules India Limited
Find a price of Dimethyl Fumarate bulk with DMF offered by Granules India Limited
Find a price of Empagliflozin bulk with DMF offered by Granules India Limited
Find a price of Esomeprazole Magnesium bulk with DMF offered by Granules India Limited
Find a price of Fexofenadine Hydrochloride bulk with DMF offered by Granules India Limited
Find a price of Ibuprofen bulk with DMF offered by Granules India Limited
Find a price of Levetiracetam bulk with DMF offered by Granules India Limited
Find a price of Levocetirizine Dihydrochloride bulk with DMF offered by Granules India Limited
Find a price of Linagliptin bulk with DMF offered by Granules India Limited
Find a price of Losartan Potassium bulk with DMF offered by Granules India Limited
Find a price of Nilotinib bulk with DMF offered by Granules India Limited
Find a price of Omeprazole bulk with DMF offered by Granules India Limited
Find a price of Omeprazole Magnesium bulk with DMF offered by Granules India Limited
Find a price of Pantoprazole Sodium bulk with DMF offered by Granules India Limited
Find a price of Paracetamol bulk with DMF offered by Granules India Limited
Find a price of Pazopanib Hydrochloride bulk with DMF offered by Granules India Limited
Find a price of Pirfenidone bulk with DMF offered by Granules India Limited
Find a price of Prazosin Hydrochloride bulk with DMF offered by Granules India Limited
Find a price of Rifaximin bulk with DMF offered by Granules India Limited
Find a price of Sorafenib bulk with DMF offered by Granules India Limited
Find a price of Trazodone Hydrochloride bulk with DMF offered by Granules India Limited
Find a price of Vigabatrin bulk with DMF offered by Granules India Limited
Find a price of Bortezomib bulk offered by Granules India Limited
Find a price of Brinzolamide bulk offered by Granules India Limited
Find a price of Cabozantinib bulk offered by Granules India Limited
Find a price of Calcium Oxybate bulk offered by Granules India Limited
Find a price of Diphenhydramine Hydrochloride bulk offered by Granules India Limited
Find a price of Elacestrant bulk offered by Granules India Limited
Find a price of Gabapentin bulk offered by Granules India Limited
Find a price of Guaifenesin bulk offered by Granules India Limited
Find a price of Ibuprofen bulk offered by Granules India Limited
Find a price of Lapatinib Ditosylate bulk offered by Granules India Limited
Find a price of Levocetirizine Dihydrochloride bulk offered by Granules India Limited
Find a price of Lisdexamfetamine Dimesylate bulk offered by Granules India Limited
Find a price of Magnesium Oxybate bulk offered by Granules India Limited
Find a price of Metformin bulk offered by Granules India Limited
Find a price of Methocarbamol bulk offered by Granules India Limited
Find a price of Olmesartan Medoxomil bulk offered by Granules India Limited
Find a price of Paracetamol bulk offered by Granules India Limited
Find a price of Penicillamine bulk offered by Granules India Limited
Find a price of Potassium Chloride bulk offered by Granules India Limited
Find a price of Ruxolitinib Phosphate bulk offered by Granules India Limited
Find a price of Tenofovir Disoproxil Succinate bulk offered by Granules India Limited
Find a price of Viloxazine Hydrochloride bulk offered by Granules India Limited