LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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01 1LGM Pharma
02 1DKSH
03 1Jai Radhe Sales
04 1Octavius Pharma Pvt. Ltd
05 1Fishfa Biogenics
06 2Chunghwa Chemical Synthesis & Biotech
07 1TAPI Technology & API Services
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01 1224MF10054
02 1224MF10107
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01 1WC-0056
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06 1WC-0226
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08 1WC-0578
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-01
Pay. Date : 2016-11-22
DMF Number : 18494
Submission : 2005-07-11
Status : Active
Type : II
NDC Package Code : 52076-6220
Start Marketing Date : 2018-01-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-23
Pay. Date : 2012-11-09
DMF Number : 20072
Submission : 2006-12-20
Status : Active
Type : II
Registration Number : 224MF10107
Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic
Initial Date of Registration : 2012-06-22
Latest Date of Registration :
Available Reg Filing : CA, ASMF |
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-01
Pay. Date : 2018-12-04
DMF Number : 33333
Submission : 2018-12-07
Status : Active
Type : II
NDC Package Code : 52076-6220
Start Marketing Date : 2018-01-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22786
Submission : 2009-05-13
Status : Inactive
Type : II
Certificate Number : CEP 2019-159 - Rev 01
Issue Date : 2024-11-27
Type : Chemical
Substance Number : 1700
Status : Valid
NDC Package Code : 65050-2101
Start Marketing Date : 2021-01-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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A Mycophenolate Mofetil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mycophenolate Mofetil, including repackagers and relabelers. The FDA regulates Mycophenolate Mofetil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mycophenolate Mofetil 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 40 companies offering Mycophenolate Mofetil
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