01 1Aclidinium Bromide
02 1Apalutamide
03 1Avacopan
04 3Beclomethasone Dipropionate
05 1Betamethasone Acetate
06 1Betamethasone Dipropionate
07 1Betamethasone Sodium Phosphate
08 1Betamethasone Valerate
09 1Clobetasol Propionate
10 1Danazol
11 1Danicopan
12 1Deucravacitinib
13 1Deutivacaftor
14 2Doxycycline
15 2Doxycycline Hyclate
16 1Encequidar
17 1Ensifentrine
18 1Enzalutamide
19 1Flumethasone
20 2Fluticasone Furoate
21 2Fluticasone Propionate
22 1Glycopyrronium Bromide
23 1Halobetasol
24 1Hydrocortisone
25 1Iohexol
26 1Iopamidol
27 1Isavuconazonium Sulfate
28 2Ivacaftor
29 2Ivermectin
30 1Ivosidenib
31 1Methacycline Hydrochloride
32 3Minocycline Hydrochloride
33 2Mometasone Furoate
34 1Omaveloxolone
35 1Plazomicin
36 1Pralsetinib
37 1Roxithromycin
38 2Salmeterol Xinafoate
39 1Simvastatin
40 1Sumatriptan
41 1Suzetrigine
42 1Tamsulosin
43 1Tenapanor Hydrochloride
44 1Tezacaftor
45 1Tucatinib
46 1Umeclidinium Bromide
47 1Vilanterol Trifenatate
48 4Blank
01 20Active
02 17Inactive
03 26Blank
01 12Valid
02 4Withdrawn by Holder
03 47Blank
01 1219MF10124
02 1220MF10125
03 1221MF10281
04 1223MF10176
05 1224MF10204
06 1303MF10022
07 1304MF10006
08 56Blank
01 63Blank
01 120210325-209-J-917
02 1Su87-26-ND
03 61Blank
01 142052-1701
02 142052-1702
03 142052-1901
04 150909-1703
05 150909-1704
06 150909-1705
07 150909-1706
08 150909-1902
09 150909-1903
10 150909-1904
11 150909-1905
12 150909-1906
13 150909-1907
14 150909-1908
15 150909-1909
16 150909-1910
17 150909-1911
18 150909-1912
19 150909-4102
20 150909-5102
21 150909-5103
22 150909-5151
23 150909-5152
24 150909-5157
25 150909-5171
26 150909-5175
27 150909-5263
28 150909-8105
29 150909-8106
30 150909-9101
31 150909-9201
32 151473-1901
33 155018-121
34 155018-151
35 155018-164
36 155018-221
37 155018-301
38 155018-302
39 155018-402
40 24Blank
01 15961
02 62Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-15
Pay. Date : 2012-12-14
DMF Number : 16334
Submission : 2002-12-20
Status : Active
Type : II
Certificate Number : CEP 2011-103 - Rev 05
Issue Date : 2024-03-07
Type : Chemical
Substance Number : 1750
Status : Valid
Registration Number : 223MF10176
Registrant's Address : Sete Casas 2674-506 Loures PORTUGAL
Initial Date of Registration : 2011-12-27
Latest Date of Registration :
NDC Package Code : 55018-301
Start Marketing Date : 2018-11-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Synex Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20210325-209-J-917
Manufacturer Name : Hovione FarmaCiencia SA
Manufacturer Address : Sete Casas, Loures, 2674-506 Portugal
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-09
Pay. Date : 2012-12-14
DMF Number : 21395
Submission : 2008-03-05
Status : Active
Type : II
Certificate Number : R1-CEP 1998-138 - Rev 05
Issue Date : 2020-02-28
Type : Chemical
Substance Number : 1336
Status : Valid
Registration Number : 221MF10281
Registrant's Address : Estrada Coronel Nicolau de Mesquita Taipa, Macau S. A. R. China
Initial Date of Registration : 2009-12-18
Latest Date of Registration :
NDC Package Code : 55018-221
Start Marketing Date : 2009-03-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-15
Pay. Date : 2012-12-14
DMF Number : 13738
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 1997-078 - Rev 09
Issue Date : 2024-07-17
Type : Chemical
Substance Number : 1030
Status : Valid
Registration Number : 219MF10124
Registrant's Address : Sete Casas 2674-506 Loures PORTUGAL
Initial Date of Registration : 2007-04-18
Latest Date of Registration :
NDC Package Code : 50909-9201
Start Marketing Date : 2015-01-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13636
Submission : 1998-09-01
Status : Inactive
Type : II
Certificate Number : CEP 1996-066 - Rev 07
Issue Date : 2024-07-18
Type : Chemical
Substance Number : 272
Status : Valid
Registration Number : 224MF10204
Registrant's Address : Estrada Coronel Nicolau de Mesquita Taipa, Macau S. A. R. China
Initial Date of Registration : 2012-10-09
Latest Date of Registration :
NDC Package Code : 50909-8105
Start Marketing Date : 2014-10-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-18
Pay. Date : 2012-12-14
DMF Number : 6687
Submission : 1986-11-18
Status : Active
Type : II
Registration Number : 220MF10125
Registrant's Address : Sete Casas 2674-506 Loures PORTUGAL
Initial Date of Registration : 2008-05-15
Latest Date of Registration :
NDC Package Code : 50909-5102
Start Marketing Date : 1986-11-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-11
Pay. Date : 2012-12-11
DMF Number : 13710
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 1997-115 - Rev 07
Issue Date : 2021-09-10
Type : Chemical
Substance Number : 820
Status : Valid
NDC Package Code : 50909-8106
Start Marketing Date : 2014-07-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31713
Submission : 2017-05-31
Status : Active
Type : II
Certificate Number : CEP 2024-146 - Rev 00
Issue Date : 2025-07-22
Type : Chemical
Substance Number : 2768
Status : Valid
NDC Package Code : 50909-5171
Start Marketing Date : 2017-05-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-24
Pay. Date : 2012-12-14
DMF Number : 24791
Submission : 2011-03-25
Status : Active
Type : II
Certificate Number : R1-CEP 2005-160 - Rev 02
Issue Date : 2019-02-27
Type : Chemical
Substance Number : 1750
Status : Valid
NDC Package Code : 50909-5175
Start Marketing Date : 2002-12-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-07-29
Pay. Date : 2015-04-28
DMF Number : 29003
Submission : 2015-01-08
Status : Active
Type : II
Certificate Number : R0-CEP 2022-299 - Rev 00
Issue Date : 2022-10-11
Type : Chemical
Substance Number : 1030
Status : Valid
NDC Package Code : 50909-9101
Start Marketing Date : 1993-07-07
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-18
Pay. Date : 2012-12-14
DMF Number : 14991
Submission : 2000-05-26
Status : Active
Type : II
Certificate Number : CEP 2018-121 - Rev 03
Issue Date : 2023-10-23
Type : Chemical
Substance Number : 2858
Status : Valid
NDC Package Code : 50909-5152
Start Marketing Date : 2012-04-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Hovione is a supplier offers 58 products (APIs, Excipients or Intermediates).
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