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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 1Elbasvir
17 1Encequidar
18 1Ensifentrine
19 1Enzalutamide
20 1Flumethasone
21 2Fluticasone Furoate
22 2Fluticasone Propionate
23 1Glycopyrronium Bromide
24 1Grazoprevir
25 1Halobetasol
26 1Hydrocortisone
27 1Iohexol
28 1Iopamidol
29 1Isavuconazonium Sulfate
30 2Ivacaftor
31 2Ivermectin
32 1Ivosidenib
33 1Ledipasvir
34 1Methacycline Hydrochloride
35 3Minocycline Hydrochloride
36 2Mometasone Furoate
37 1Omaveloxolone
38 2Orforglipron Calcium Hydrate
39 1Pirtobrutinib
40 1Plazomicin
41 1Pralsetinib
42 1Roxithromycin
43 2Salmeterol Xinafoate
44 1Sarolaner
45 1Simvastatin
46 1Sumatriptan
47 1Suzetrigine
48 1Tamsulosin
49 1Tenapanor Hydrochloride
50 1Tezacaftor
51 1Tucatinib
52 1Umeclidinium Bromide
53 1Velpatasvir
54 1Vilanterol Trifenatate
55 1Vimseltinib
56 1Zongertinib
57 6Blank
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01 20Active
02 17Inactive
03 38Blank
01 12Valid
02 4Withdrawn by Holder
03 59Blank
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01 1219MF10124
02 1220MF10125
03 1221MF10281
04 1223MF10176
05 1224MF10204
06 1303MF10022
07 1304MF10006
08 68Blank
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01 75Blank
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01 120210325-209-J-917
02 1Su87-26-ND
03 73Blank
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01 142052-1701
02 142052-1702
03 142052-1901
04 150909-1703
05 150909-1704
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 150909-1919
26 150909-1920
27 150909-1921
28 150909-1923
29 150909-1924
30 150909-1925
31 150909-4102
32 150909-5102
33 150909-5103
34 150909-5151
35 150909-5152
36 150909-5157
37 150909-5171
38 150909-5175
39 150909-5263
40 150909-8105
41 150909-8106
42 150909-9101
43 150909-9201
44 151473-1901
45 155018-121
46 155018-151
47 155018-164
48 155018-221
49 155018-301
50 155018-302
51 155018-402
52 24Blank
01 15961
02 74Blank
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 : 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 : 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

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 : R1-CEP 2004-111 - Rev 02
Issue Date : 2021-10-29
Type : Chemical
Substance Number : 1449
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 69 products (APIs, Excipients or Intermediates).
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