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

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03 1Pharmathen SA
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01 17Active
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01 112869-038
02 117337-0040
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06 161876-0072
07 163310-2410
08 165015-798
09 165015-818
10 165862-756
11 165977-0070
12 166639-010
13 169875-8044
14 170966-0037
15 171666-008
16 172761-029
17 184206-0098
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-07
Pay. Date : 2017-04-28
DMF Number : 31546
Submission : 2017-05-12
Status : Active
Type : II
| Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-09
Pay. Date : 2012-12-21
DMF Number : 23044
Submission : 2009-08-04
Status : Active
Type : II
Certificate Number : CEP 2023-217 - Rev 00
Issue Date : 2025-04-29
Type : Chemical
Substance Number : 2930
Status : Valid
NDC Package Code : 17337-0327
Start Marketing Date : 2023-07-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2018-09-05
Pay. Date : 2018-06-22
DMF Number : 32488
Submission : 2018-06-29
Status : Active
Type : II
NDC Package Code : 17337-0320
Start Marketing Date : 2022-12-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2021-03-24
Pay. Date : 2020-12-29
DMF Number : 34600
Submission : 2020-02-26
Status : Active
Type : II
Certificate Number : CEP 2023-375 - Rev 00
Issue Date : 2024-12-17
Type : Chemical
Substance Number : 2930
Status : Valid
NDC Package Code : 72761-029
Start Marketing Date : 2021-05-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30023
Submission : 2015-11-12
Status : Active
Type : II
NDC Package Code : 12869-038
Start Marketing Date : 2001-03-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-13
Pay. Date : 2021-09-29
DMF Number : 35107
Submission : 2021-09-19
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19060
Submission : 2005-12-21
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23946
Submission : 2010-07-06
Status : Inactive
Type : II

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A Valcyte manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valcyte, including repackagers and relabelers. The FDA regulates Valcyte manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valcyte 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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A Valcyte supplier is an individual or a company that provides Valcyte active pharmaceutical ingredient (API) or Valcyte finished formulations upon request. The Valcyte suppliers may include Valcyte API manufacturers, exporters, distributors and traders.
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