LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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01 1LGM Pharma
02 1Evonik
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04 1HRV Global Life Sciences
05 1Anhui Biochem Pharmaceutical
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09 1Blanver
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13 1Dasami Lab
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24 1Nortec Quimica
25 1Shanghai Desano Bio-Pharmaceutical
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08 6U.S.A
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01 13Active
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01 1229MF10061
02 1229MF10167
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01 1WC-0016
02 1WC-0023
03 1WC-0041
04 1WC-0065
05 1WC-0065a
06 1WC-0079
07 2WC-0117
08 1WC-0119
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01 11646-18-ND
02 1205-21-ND
03 1No. 4945-20-ND
04 1Su205-13-ND
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01 133342-500
02 142385-304
03 149711-1516
04 152696-0008
05 153104-7637
06 159116-7480
07 159997-0005
08 165015-827
09 165015-838
10 165015-883
11 165862-305
12 166721-400
13 168554-0027
14 168554-0064
15 170966-0024
16 172761-007
17 172761-008
18 184206-0040
19 184206-0041
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
NDC Package Code : 52696-0008
Start Marketing Date : 2007-10-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2014-12-04
Registration Number : No. 4945-20-ND
Manufacturer Name : Evonik Operations GmbH
Manufacturer Address : Gutenbergstrasse 2, 69221 Dossenheim, Germany
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-21
Pay. Date : 2013-05-14
DMF Number : 19566
Submission : 2006-06-30
Status : Active
Type : II
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-883
Start Marketing Date : 2017-12-11
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 : 32096
Submission : 2017-11-15
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-05
Pay. Date : 2013-02-07
DMF Number : 25617
Submission : 2011-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24975
Submission : 2011-05-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28505
Submission : 2014-08-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21706
Submission : 2008-06-17
Status : Inactive
Type : II
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A COMPLERA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of COMPLERA, including repackagers and relabelers. The FDA regulates COMPLERA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. COMPLERA 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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