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01 1Aclidinium Bromide
02 1Apalutamide
03 1Avacopan
04 3Beclomethasone Dipropionate
05 1Belzutifan
06 1Betamethasone Acetate
07 1Betamethasone Dipropionate
08 1Betamethasone Sodium Phosphate
09 1Betamethasone Valerate
10 1Clobetasol Propionate
11 1Danazol
12 1Danicopan
13 1Deucravacitinib
14 1Deutivacaftor
15 1Dihydroergotamine Mesylate
16 1Doravirine
17 2Doxycycline
18 2Doxycycline Hyclate
19 1Elbasvir
20 1Encequidar
21 1Ensifentrine
22 1Enzalutamide
23 1Flumethasone
24 2Fluticasone Furoate
25 2Fluticasone Propionate
26 1Glycopyrronium Bromide
27 1Grazoprevir
28 1Halobetasol
29 1Hydrocortisone
30 1Iohexol
31 1Iopamidol
32 1Isavuconazonium Sulfate
33 2Ivacaftor
34 2Ivermectin
35 2Ivosidenib
36 2Ledipasvir
37 1Methacycline Hydrochloride
38 3Minocycline Hydrochloride
39 2Mometasone Furoate
40 1Omaveloxolone
41 4Orforglipron Calcium Hydrate
42 1Paltusotine
43 1Pirtobrutinib
44 1Pralsetinib
45 1Quizartinib
46 1Roxithromycin
47 2Salmeterol Xinafoate
48 1Sarolaner
49 1Simvastatin
50 1Sumatriptan
51 2Suzetrigine
52 1Tamsulosin
53 1Tenapanor Hydrochloride
54 1Tezacaftor
55 1Tucatinib
56 1Umeclidinium Bromide
57 2Velpatasvir
58 1Vilanterol Trifenatate
59 1Vimseltinib
60 1Zongertinib
61 4Blank
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01 18Active
02 19Inactive
03 46Blank
01 12Valid
02 4Withdrawn by Holder
03 67Blank
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01 1219MF10124
02 1220MF10125
03 1221MF10281
04 1223MF10176
05 1224MF10204
06 1303MF10022
07 1304MF10006
08 1307MF10155
09 75Blank
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01 83Blank
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01 120210325-209-J-917
02 1Su256-7-ND
03 1Su87-26-ND
04 80Blank
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01 142052-1701
02 142052-1702
03 142052-1901
04 142052-1902
05 150909-1703
06 150909-1705
07 150909-1706
08 150909-1707
09 150909-1901
10 150909-1902
11 150909-1903
12 150909-1904
13 150909-1905
14 150909-1906
15 150909-1907
16 150909-1908
17 150909-1909
18 150909-1910
19 150909-1911
20 150909-1912
21 150909-1913
22 150909-1914
23 150909-1915
24 150909-1916
25 150909-1917
26 150909-1918
27 150909-1919
28 150909-1920
29 150909-1921
30 150909-1923
31 150909-1924
32 150909-1925
33 150909-1926
34 150909-4102
35 150909-5102
36 150909-5103
37 150909-5151
38 150909-5152
39 150909-5157
40 150909-5171
41 150909-5175
42 150909-5263
43 150909-8105
44 150909-8106
45 150909-9101
46 150909-9201
47 151473-1901
48 151473-1902
49 151473-1903
50 151473-1904
51 151473-1905
52 151473-1906
53 155018-121
54 155018-151
55 155018-164
56 155018-221
57 155018-301
58 155018-302
59 155018-402
60 24Blank
01 15961
02 82Blank
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 : R0-CEP 2022-299 - Rev 00
Issue Date : 2022-10-11
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 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 : 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 : CEP 1997-078 - Rev 09
Issue Date : 2024-07-17
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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