LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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01 1LGM Pharma
02 1Pfanstiehl
03 1Ahk Tech
04 1Apotex Pharmachem
05 2Archimica
06 1Asahi Kasei Finechem
07 1Axitec
08 1Biesterfeld Spezialchemie GmbH
09 1Fujian South Pharmaceutical
10 1Guangzhou Tosun Pharmaceutical
11 1Kekule Pharma
12 1Linnea SA
13 1Mac-Chem Products (India) Pvt.Ltd
14 1Pfizer Inc
15 1Roche Diagnostics GmbH
16 1Sakar Healthcare
17 1Shenzhen Haorui
18 1Shouyuan Chemical
19 1Surajlok Chemicals
20 1Tecoland Corporation
21 1Vannsh Life Sciences
22 1Wuhan Wuyao Pharmaceutical
23 1Yamasa Corporation
24 1Zhejiang Hisun Chemical Co., Ltd.
25 1Zhejiang Hisun Pharmaceutical
26 5Blank
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01 1Canada
02 9China
03 2Germany
04 5India
05 2Italy
06 2Japan
07 1Switzerland
08 4U.S.A
09 5Blank
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01 3Active
02 12Inactive
03 16Blank
01 4Valid
02 1Withdrawn by Holder
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01 1217MF10811
02 1218MF10475
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01 1WC-0275
02 1WC-0435
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01 120220713-210-J-1332
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01 112848-1003
02 155512-0026
03 158623-0026
04 167430-075
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01 31Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
NDC Package Code : 67430-075
Start Marketing Date : 2017-01-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-18
Pay. Date : 2012-12-18
DMF Number : 15959
Submission : 2002-04-28
Status : Active
Type : II
Certificate Number : R1-CEP 2001-390 - Rev 03
Issue Date : 2016-08-02
Type : Chemical
Substance Number : 760
Status : Withdrawn by Holder
NDC Package Code : 58623-0026
Start Marketing Date : 2004-01-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-18
Pay. Date : 2013-01-15
DMF Number : 25267
Submission : 2011-09-07
Status : Active
Type : II
Certificate Number : CEP 2023-289 - Rev 00
Issue Date : 2024-02-06
Type : Chemical
Substance Number : 760
Status : Valid
NDC Package Code : 55512-0026
Start Marketing Date : 2019-12-17
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 : 23469
Submission : 2010-01-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26281
Submission : 2012-05-24
Status : Inactive
Type : II
Certificate Number : CEP 2012-251 - Rev 02
Issue Date : 2024-04-30
Type : Chemical
Substance Number : 760
Status : Valid
Date of Issue : 2021-01-22
Valid Till : 2023-08-01
Written Confirmation Number : WC-0275
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18071
Submission : 2005-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1534
Submission : 1970-06-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9468
Submission : 1991-12-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7770
Submission : 1988-11-21
Status : Inactive
Type : II
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