Chirogate is a professional Prostaglandin manufacturer.

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01 1Chirogate International
02 1EUROAPI
03 1LGM Pharma
04 1Arena Pharmaceuticals Ltd
05 1Bills Biotech
06 1CASCADE BIOCHEMICAL LTD
07 1CHEMO
08 1Darmerica
09 1Everlight Chemical
10 1Evotec
11 1Guangzhou Tosun Pharmaceutical
12 1Letco Medical
13 1MSN Laboratories
14 1Medisca
15 1NEWCHEM SPA
16 1Nissan Chemical
17 2Ono Pharmaceutical
18 1Pfizer Inc
19 1Spectrum Chemical
20 1TIEN (Tianjin) Pharmaceutical
21 1Unipex
22 1Yonsung Fine Chemicals
23 1Zhejiang Ausun Pharmaceutical
24 5Blank
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01 3China
02 2France
03 1Germany
04 2India
05 1Italy
06 3Japan
07 1South Korea
08 1Spain
09 2Taiwan
10 6U.S.A
11 2United Kingdom
12 5Blank
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01 3Active
02 5Inactive
03 21Blank
01 2Valid
02 27Blank
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01 1220MF10064
02 1306MF10135
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01 29Blank
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01 120230202-210-J-1440
02 120240206-210-J-1611
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01 10009-0042
02 138779-0944
03 140016-010
04 149452-0073
05 151927-2196
06 162991-1128
07 163902-100
08 165035-101
09 168245-0007
10 171052-146
11 173212-075
12 182231-101
13 185207-021
14 185512-2113
15 185941-005
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01 29Blank
NDC Package Code : 68245-0007
Start Marketing Date : 2005-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10948
Submission : 1994-06-20
Status : Active
Type : II
Certificate Number : R1-CEP 2015-302 - Rev 00
Issue Date : 2022-01-31
Type : Chemical
Substance Number : 1488
Status : Valid
Registration Number : 220MF10064
Registrant's Address : To (´) utca 1-5. , 1045 Budapest, Hungary
Initial Date of Registration : 2008-02-25
Latest Date of Registration :
NDC Package Code : 82231-101
Start Marketing Date : 2014-10-28
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-02-02
Registration Number : 20230202-210-J-1440
Manufacturer Name : EUROAPI Hungary Ltd.
Manufacturer Address : To utca 1-5., Budapest, 1045, Hungary
| Available Reg Filing : CN |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34239
Submission : 2020-04-21
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-06
Pay. Date : 2015-07-16
DMF Number : 21233
Submission : 2008-01-15
Status : Active
Type : II
Certificate Number : CEP 2012-204 - Rev 02
Issue Date : 2025-10-28
Type : Chemical
Substance Number : 1488
Status : Valid
NDC Package Code : 65035-101
Start Marketing Date : 2016-08-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11534
Submission : 1995-05-31
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21906
Submission : 2008-07-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13249
Submission : 1998-09-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11845
Submission : 1996-02-06
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12569
Submission : 1997-07-02
Status : Inactive
Type : II

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A Prostaglandin E1;Edex;Muse;Liprostin;Caverject manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prostaglandin E1;Edex;Muse;Liprostin;Caverject, including repackagers and relabelers. The FDA regulates Prostaglandin E1;Edex;Muse;Liprostin;Caverject manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prostaglandin E1;Edex;Muse;Liprostin;Caverject API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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