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01 3Alfentanil Hydrochloride
02 4Amphetamine
03 2Amphetamine Aspartate
04 1Apomorphine Hydrochloride
05 1Atropine Sulfate
06 1Auranofin
07 2Buprenorphine
08 2Buprenorphine Hydrochloride
09 1Calcium Oxybate
10 1Cannabidiol
11 2Carboplatin
12 1Carmustine
13 1Cisplatin
14 1Cocaine Hydrochloride
15 1Codeine
16 2Codeine Phosphate
17 1Decitabine
18 1Dexmethylphenidate
19 2Dextroamphetamine Saccharate
20 1Diamorphine Hydrochloride
21 1Difenoxin Hydrochloride
22 2Dihydrocodeine Tartrate
23 1Diphenoxylate Hydrochloride
24 2Dofetilide
25 1Edrophonium Chloride
26 2Fentanyl
27 2Fentanyl Citrate
28 1Fentanyl Hydrochloride
29 1Hydrocodone Bitartrate
30 2Hydromorphone Hydrochloride
31 1Isoproterenol Hydrochloride
32 1Lenalidomide
33 2Lisdexamfetamine Dimesylate
34 1Lurasidone Hydrochloride
35 1Magnesium Oxybate
36 1Methamphetamine Hydrochloride
37 1Methylphenidate
38 2Methylphenidate Hydrochloride
39 1Miglustat
40 2Morphine Hydrochloride
41 3Morphine Sulfate
42 1Nabilone
43 2Naloxone Hydrochloride
44 1Nintedanib Esylate
45 1Opium
46 3Oxycodone Hydrochloride
47 1Oxymorphone Hydrochloride
48 1Pirfenidone
49 1Potassium Oxybate
50 3Remifentanil
51 2Sodium Oxybate
52 2Sufentanil Citrate
53 1Tetrahydrocannabinol
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01 48Active
02 33Blank
01 25Valid
02 56Blank
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01 1218MF11027
02 1222MF10101
03 1222MF10106
04 1223MF10092
05 1302MF10009
06 76Blank
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01 81Blank
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01 120190812-209-J-406
02 120190812-209-J-406(1)
03 120190812-209-J-406(2)
04 120191223-209-J-267
05 120191223-209-J-267(2)
06 120191223-209-J-267(A)
07 120210310-209-J-865
08 120210310-209-J-865(A)
09 120210316-209-J-603
10 120210316-209-J-603(1)
11 120210427-209-J-837
12 120210427-209-J-837(1)
13 120210615-211-J-1028
14 120210615-211-J-1028(A)
15 120210622-210-J-918
16 120210622-210-J-918(A)
17 120220112-210-J-1208
18 120220112-210-J-1208(A)
19 120220204-211-J-1228
20 120220204-211-J-1228(A)
21 120220421-210-J-1273
22 120220421-210-J-1273(A)
23 120220422-210-J-1275
24 120220422-210-J-1275(A)
25 120220422-210-J-1275(B)
26 1Number 5-1-ND
27 1Number 5-1-ND(1)
28 1Number 5-1-ND(2)
29 53Blank
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01 112707-031
02 112707-035
03 112707-036
04 112707-037
05 149812-0001
06 149812-0004
07 149812-0009
08 249812-0010
09 149812-0011
10 149812-0020
11 149812-0021
12 149812-0026
13 149812-0032
14 149812-0033
15 149812-0058
16 149812-0059
17 149812-0060
18 149812-0061
19 149812-0067
20 149812-0076
21 149812-0110
22 149812-0124
23 149812-0132
24 149812-0136
25 149812-0141
26 149812-0149
27 149812-0150
28 149812-0156
29 149812-0163
30 149812-0182
31 149812-0183
32 149812-0186
33 149812-0195
34 149812-0207
35 149812-0239
36 149812-0248
37 149812-0261
38 149812-0270
39 149812-0295
40 150137-0686
41 150137-4147
42 150137-4237
43 150137-4245
44 37Blank
01 81Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-29
Pay. Date : 2013-10-23
DMF Number : 13188
Submission : 1998-09-11
Status : Active
Type : II
Certificate Number : R1-CEP 2006-237 - Rev 03
Issue Date : 2020-12-16
Type : Chemical
Substance Number : 136
Status : Valid
Registration Number : 223MF10092
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2011-06-29
Latest Date of Registration :
NDC Package Code : 12707-031
Start Marketing Date : 2017-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-26
Pay. Date : 2012-11-30
DMF Number : 19109
Submission : 2006-01-12
Status : Active
Type : II
Certificate Number : R1-CEP 2002-168 - Rev 07
Issue Date : 2019-09-25
Type : Chemical
Substance Number : 1181
Status : Valid
Registration Number : 218MF11027
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2006-12-28
Latest Date of Registration :
NDC Package Code : 12707-035
Start Marketing Date : 2017-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Available Reg. Filing : ROW |
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-13
Pay. Date : 2015-02-02
DMF Number : 7145
Submission : 1987-09-17
Status : Active
Type : II
Certificate Number : R1-CEP 2004-104 - Rev 03
Issue Date : 2023-03-27
Type : Chemical
Substance Number : 1081
Status : Valid
Registration Number : 222MF10101
Registrant's Address : 435 Devon Park Drive, Suite 400, Wayne, Pennsylvania 19087 USA
Initial Date of Registration : 2010-03-18
Latest Date of Registration :
NDC Package Code : 49812-0010
Start Marketing Date : 2014-01-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg. Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9601
Submission : 1992-03-26
Status : Active
Type : II
Certificate Number : CEP 2005-253 - Rev 02
Issue Date : 2025-01-22
Type : Chemical
Substance Number : 599
Status : Valid
Registration Number : 222MF10106
Registrant's Address : 435 Devon Park Drive, Suite 400, Wayne, Pennsylvania 19087 USA
Initial Date of Registration : 2010-03-19
Latest Date of Registration :
NDC Package Code : 49812-0009
Start Marketing Date : 1985-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10137
Submission : 1993-03-05
Status : Active
Type : II
Certificate Number : CEP 2017-119 - Rev 01
Issue Date : 2024-10-14
Type : Chemical
Substance Number : 2235
Status : Valid
Registration Number : 302MF10009
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2020-01-17
Latest Date of Registration :
NDC Package Code : 49812-0020
Start Marketing Date : 2010-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hwanin Pharmaceutical Co., Ltd.
Registration Date : 2021-12-17
Registration Number : 20210427-209-J-837(1)
Manufacturer Name : Macfarlan Smith Limited@Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom@Three Trees Road, Newbie, Annan, DG12 5QH, United Kingdom
Available Reg. Filing : ROW |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12661
Submission : 1997-09-19
Status : Active
Type : II
Certificate Number : R1-CEP 2010-008 - Rev 03
Issue Date : 2021-08-03
Type : Chemical
Substance Number : 1062
Status : Valid
NDC Package Code : 49812-0033
Start Marketing Date : 1997-09-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Nosa Chemical Co., Ltd.
Registration Date : 2022-08-29
Registration Number : 20220422-210-J-1275(B)
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10, Wheatfield Road, Edinburgh EH11 2QA, Scotland, UK
Available Reg. Filing : ROW |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-08
Pay. Date : 2012-12-12
DMF Number : 26448
Submission : 2012-09-17
Status : Active
Type : II
Certificate Number : R1-CEP 2006-009 - Rev 04
Issue Date : 2019-12-11
Type : Chemical
Substance Number : 1180
Status : Valid
NDC Package Code : 12707-036
Start Marketing Date : 2017-12-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT FOR ...
Available Reg. Filing : ROW |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20787
Submission : 2007-08-23
Status : Active
Type : II
Certificate Number : R1-CEP 2016-295 - Rev 00
Issue Date : 2022-10-06
Type : Chemical
Substance Number : 74
Status : Valid
Registrant Name : Samung Industrial Co., Ltd.
Registration Date : 2021-03-16
Registration Number : 20210316-209-J-603
Manufacturer Name : Macfarlan Smith Limited@Macfarlan Smith Limited@Tasmanian Alkaloids Pty Limited
Manufacturer Address : Three Trees Road Newbie, Annan DG12 5QH United Kingdom@10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom@160 Birralee Road, Westbury, Tasmania, 7303, Australia
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-18
Pay. Date : 2012-12-13
DMF Number : 6217
Submission : 1986-02-25
Status : Active
Type : II
Certificate Number : R1-CEP 2000-141 - Rev 03
Issue Date : 2013-03-04
Type : Chemical
Substance Number : 1210
Status : Valid
NDC Package Code : 49812-0004
Start Marketing Date : 1985-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samung Industrial Co., Ltd.
Registration Date : 2021-08-26
Registration Number : 20210615-211-J-1028(A)
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Available Reg. Filing : ROW |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5038
Submission : 1983-08-15
Status : Active
Type : II
Certificate Number : R1-CEP 2000-303 - Rev 04
Issue Date : 2014-10-13
Type : Chemical
Substance Number : 1103
Status : Valid
NDC Package Code : 49812-0001
Start Marketing Date : 1985-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Baeksu Pharmaceutical Co., Ltd.
Registration Date : 2021-06-22
Registration Number : 20210622-210-J-918
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Available Reg. Filing : ROW |
Veranova is a supplier offers 71 products (APIs, Excipients or Intermediates).
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