LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Veranova
03 1HRV Global Life Sciences
04 1Shanghai Minbiotech
05 1Acebright Group
06 1Aspen Biopharma Labs
07 1Aspire Lifesciences Pvt Ltd
08 1Biesterfeld Spezialchemie GmbH
09 1Biotechnica DWC
10 1Bo-Chem Pvt Ltd
11 1ChemGenix Laboratories Pvt Ltd
12 1Cipla
13 1Desynth
14 1Fresenius Kabi AB Brunna
15 1Fresenius Kabi Oncology Limited
16 1Hangzhou Longshine Bio-Tech
17 1Hanways Chempharm
18 1Heraeus Holding
19 1Hetero Drugs
20 1Hospira, Inc.
21 1IDT Australia Limited
22 1KUNMING GUIYAN PHARMACEUTICAL CO., LTD. CN 650 033 Kunming
23 2Laurus Labs
24 1Mac-Chem Products (India) Pvt.Ltd
25 1Nishchem International Pvt. Ltd
26 1PLIVA LACHEMA
27 1Pliva Hrvatska
28 2Qilu Pharmaceutical
29 1Sakar Healthcare
30 1Shandong Boyuan Pharmaceutical
31 1Shilpa Medicare
32 1Strem Chemicals
33 1Sun Pharmaceutical Industries Limited
34 1TAPI Technology & API Services
35 1Tecoland Corporation
36 1Teva Pharmaceutical Industries
37 1Umicore
38 1Unipex
39 1Vinkem Labs Ltd
40 1Blank
01 1Algeria
02 1Argentina
03 1Australia
04 8China
05 2Croatia
06 1France
07 3Germany
08 16India
09 2Israel
10 1Sweden
11 5U.S.A
12 1Blank
01 11Active
02 6Inactive
03 25Blank
01 2Expired
02 12Valid
03 3Withdrawn by Holder
04 25Blank
01 1218MF10412
02 1218MF10722
03 1222MF10041
04 1222MF10101
05 1226MF10121
06 37Blank
01 1WC-0041
02 1WC-0115
03 1WC-0159
04 1WC-0177
05 1WC-0177A
06 1WC-0275
07 36Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-13
Pay. Date : 2015-02-02
DMF Number : 7145
Submission : 1987-09-17
Status : Active
Type : II
Certificate Number : R1-CEP 2004-104 - Rev 03
Issue Date : 2023-03-27
Type : Chemical
Substance Number : 1081
Status : Valid
Registration Number : 222MF10101
Registrant's Address : 435 Devon Park Drive, Suite 400, Wayne, Pennsylvania 19087 USA
Initial Date of Registration : 2010-03-18
Latest Date of Registration : --
NDC Package Code : 49812-0010
Start Marketing Date : 2014-01-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26029
Submission : 2012-05-08
Status : Active
Type : II
Certificate Number : R1-CEP 2012-147 - Rev 01
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 1081
Status : Withdrawn by Holder
Date of Issue : 2021-01-22
Valid Till : 2023-08-01
Written Confirmation Number : WC-0275
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-23
Pay. Date : 2014-03-06
DMF Number : 28047
Submission : 2014-03-10
Status : Active
Type : II
Certificate Number : R1-CEP 2009-264 - Rev 03
Issue Date : 2019-10-24
Type : Chemical
Substance Number : 1081
Status : Valid
Registration Number : 226MF10121
Registrant's Address : Calle 14, Nr. 229 (Lote 13), B1629MXA, Parque Industrial Pilar, Buenos Aires, Argentina
Initial Date of Registration : 2014-06-18
Latest Date of Registration : --
NDC Package Code : 72659-863
Start Marketing Date : 2017-01-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15938
Submission : 2002-04-18
Status : Active
Type : II
Certificate Number : R1-CEP 2002-129 - Rev 01
Issue Date : 2008-09-16
Type : Chemical
Substance Number : 1081
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29100
Submission : 2015-02-10
Status : Active
Type : II
Certificate Number : CEP 2009-383 - Rev 04
Issue Date : 2024-06-26
Type : Chemical
Substance Number : 1081
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16280
Submission : 2002-12-02
Status : Inactive
Type : II
Certificate Number : R0-CEP 2005-157 - Rev 00
Issue Date : 2007-10-02
Type : Chemical
Substance Number : 1081
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16709
Submission : 2003-07-15
Status : Inactive
Type : II
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