LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
NDC Package Code : 50137-4051
Start Marketing Date : 2010-01-01
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : EXPORT ONLY
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-18
Pay. Date : 2015-09-28
DMF Number : 29792
Submission : 2015-09-09
Status : Active
Type : II
Date of Issue : 2025-10-01
Valid Till : 2028-07-02
Written Confirmation Number : WC-0087
Address of the Firm :

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30799
Submission : 2016-07-19
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-18
Pay. Date : 2014-11-19
DMF Number : 28781
Submission : 2014-11-18
Status : Active
Type : II
NDC Package Code : 16436-0111
Start Marketing Date : 2014-02-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31133
Submission : 2016-12-05
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-02
Pay. Date : 2021-07-22
DMF Number : 36105
Submission : 2021-07-22
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-20
Pay. Date : 2014-04-15
DMF Number : 24505
Submission : 2010-12-21
Status : Active
Type : II
Date of Issue : 2023-05-10
Valid Till : 2026-05-10
Written Confirmation Number : WC-0015
Address of the Firm :

GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-23
Pay. Date : 2013-09-27
DMF Number : 27505
Submission : 2013-09-30
Status : Active
Type : II
NDC Package Code : 64220-156
Start Marketing Date : 2025-01-08
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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PharmaCompass offers a list of Ambrisentan API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ambrisentan manufacturer or Ambrisentan supplier for your needs.
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A Ambrisentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ambrisentan, including repackagers and relabelers. The FDA regulates Ambrisentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ambrisentan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ambrisentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ambrisentan supplier is an individual or a company that provides Ambrisentan active pharmaceutical ingredient (API) or Ambrisentan finished formulations upon request. The Ambrisentan suppliers may include Ambrisentan API manufacturers, exporters, distributors and traders.
click here to find a list of Ambrisentan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
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