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01 1Aclidinium Bromide
02 1Apalutamide
03 1Aprocitentan
04 1Avacopan
05 3Beclomethasone Dipropionate
06 1Belzutifan
07 1Betamethasone Acetate
08 1Betamethasone Dipropionate
09 1Betamethasone Sodium Phosphate
10 1Betamethasone Valerate
11 1Clobetasol Propionate
12 1Danazol
13 1Danicopan
14 1Deucravacitinib
15 1Deutivacaftor
16 1Dihydroergotamine Mesylate
17 1Doravirine
18 2Doxycycline
19 2Doxycycline Hyclate
20 1Elbasvir
21 1Encequidar
22 1Ensifentrine
23 1Enzalutamide
24 1Flumethasone
25 2Fluticasone Furoate
26 2Fluticasone Propionate
27 1Glycopyrronium Bromide
28 1Grazoprevir
29 1Halobetasol
30 1Hydrocortisone
31 1Iohexol
32 1Iopamidol
33 1Isavuconazonium Sulfate
34 2Ivacaftor
35 2Ivermectin
36 2Ivosidenib
37 2Ledipasvir
38 1Methacycline Hydrochloride
39 3Minocycline Hydrochloride
40 2Mometasone Furoate
41 1Omaveloxolone
42 4Orforglipron Calcium Hydrate
43 1Paltusotine
44 1Pirtobrutinib
45 1Pralsetinib
46 1Quizartinib
47 1Roxithromycin
48 2Salmeterol Xinafoate
49 1Sarolaner
50 1Simvastatin
51 1Sumatriptan
52 2Suzetrigine
53 1Tamsulosin
54 1Tenapanor Hydrochloride
55 1Tezacaftor
56 1Tucatinib
57 1Umeclidinium Bromide
58 2Velpatasvir
59 1Vilanterol Trifenatate
60 1Vimseltinib
61 1Zongertinib
62 4Blank
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01 18Active
02 19Inactive
03 47Blank
01 12Valid
02 4Withdrawn by Holder
03 68Blank
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01 1219MF10124
02 1220MF10125
03 1221MF10281
04 1223MF10176
05 1224MF10204
06 1303MF10022
07 1304MF10006
08 1307MF10155
09 76Blank
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01 84Blank
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01 120210325-209-J-917
02 1Su256-7-ND
03 1Su87-26-ND
04 81Blank
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01 142052-1701
02 142052-1702
03 142052-1703
04 142052-1901
05 142052-1902
06 150909-1703
07 150909-1705
08 150909-1706
09 150909-1707
10 150909-1901
11 150909-1902
12 150909-1903
13 150909-1904
14 150909-1905
15 150909-1906
16 150909-1907
17 150909-1908
18 150909-1909
19 150909-1910
20 150909-1911
21 150909-1912
22 150909-1913
23 150909-1914
24 150909-1915
25 150909-1916
26 150909-1917
27 150909-1918
28 150909-1919
29 150909-1920
30 150909-1921
31 150909-1923
32 150909-1924
33 150909-1925
34 150909-1926
35 150909-4102
36 150909-5102
37 150909-5103
38 150909-5151
39 150909-5152
40 150909-5157
41 150909-5171
42 150909-5175
43 150909-5263
44 150909-8105
45 150909-8106
46 150909-9101
47 150909-9201
48 151473-1901
49 151473-1902
50 151473-1903
51 151473-1904
52 151473-1905
53 151473-1906
54 155018-121
55 155018-151
56 155018-164
57 155018-221
58 155018-301
59 155018-302
60 155018-402
61 24Blank
01 15961
02 83Blank
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 : 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 : 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
Registration Number : 307MF10155
Registrant's Address : Sete Casas 2674-506 Loures PORTUGAL
Initial Date of Registration : 2025-12-23
Latest Date of Registration :
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

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 08
Issue Date : 2026-04-16
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 : 55018-302
Start Marketing Date : 2017-05-31
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 : 2014-01-24
Pay. Date : 2012-12-14
DMF Number : 24791
Submission : 2011-03-25
Status : Active
Type : II
Certificate Number : CEP 2005-160 - Rev 03
Issue Date : 2025-12-02
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

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