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 1Alfa Chemistry
05 1Apotex Pharmachem
06 2Archimica
07 1Asahi Kasei Finechem
08 1Axitec
09 1Biesterfeld Spezialchemie GmbH
10 1Bo-Chem
11 1Fujian South Pharmaceutical
12 1Guangzhou Tosun Pharmaceutical
13 1Kekule Pharma
14 1Linnea SA
15 1Mac-Chem Products (India) Pvt.Ltd
16 1Pfizer Inc
17 1Roche Diagnostics GmbH
18 1Sakar Healthcare
19 1Shenzhen Haorui
20 1Shouyuan Chemical
21 1Surajlok Chemicals
22 1Tecoland Corporation
23 1Vannsh Life Sciences
24 1Wuhan Wuyao Pharmaceutical
25 1Yamasa Corporation
26 1Zhejiang Hisun Chemical Co., Ltd.
27 1Zhejiang Hisun Pharmaceutical
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01 1Canada
02 9China
03 2Germany
04 6India
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06 2Japan
07 1Switzerland
08 5U.S.A
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01 3Active
02 12Inactive
03 18Blank
01 4Valid
02 1Withdrawn by Holder
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01 1217MF10811
02 1218MF10475
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01 1WC-0275
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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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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 : 2013-12-18
Pay. Date : 2013-01-15
DMF Number : 25267
Submission : 2011-09-07
Status : Active
Type : II
Certificate Number : R1-CEP 2000-048 - Rev 04
Issue Date : 2020-10-16
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 : 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 : 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 : 7770
Submission : 1988-11-21
Status : Inactive
Type : II
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 : 9468
Submission : 1991-12-18
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 : 2024-05-20
Valid Till : 2027-05-19
Written Confirmation Number : WC-0275
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1534
Submission : 1970-06-01
Status : Inactive
Type : II
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