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01 120181029-209-J-98
02 120181029-209-J-98(A)
03 120201125-209-J-437
04 120201125-209-J-437(1)
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Date of Issue : 2025-08-05
Valid Till : 2028-06-25
Written Confirmation Number : WC-0054
Address of the Firm :
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2022-05-03
Registration Number : 20181029-209-J-98(A)
Manufacturer Name : Ami Lifesciences Private Limited
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India
| Available Reg Filing : ASMF, CN, MX |
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2018-10-29
Registration Number : 20181029-209-J-98
Manufacturer Name : Ami Lifesciences Private Limited.
Manufacturer Address : Block No.82/B, ECP Road, At & Post. Karakhadi, Tal-Padra, City: Karakhadi-391 450, Dist: Vadodara. Gujarat State India
| Available Reg Filing : ASMF, CN, MX |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26794
Submission : 2012-12-27
Status : Active
Type : II
Date of Issue : 2022-08-16
Valid Till : 2025-07-15
Written Confirmation Number : WC-0042N
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7643
Submission : 1988-08-17
Status : Inactive
Type : II

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Date of Issue : 2025-11-04
Valid Till : 2028-11-03
Written Confirmation Number : WC-0626
Address of the Firm :

Date of Issue : 2025-10-29
Valid Till : 2028-10-28
Written Confirmation Number : WC-0411
Address of the Firm :

Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2025-09-01
Registration Number : 20250901-209-J-1999
Manufacturer Name : Kores (India) Limited
Manufacturer Address : Plot No. 58/1, 58/2, 59A, 65A, 65B, 65C & 66A, MIDC Industrial Area, Dhatav, Tal - Roha, Dist – Raigad Raigad 402116, Maharashtra State, India.

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A Doxofylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Doxofylline, including repackagers and relabelers. The FDA regulates Doxofylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Doxofylline 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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We have 20 companies offering Doxofylline
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