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 1TAPI Technology & API Services
06 1Aspen Biopharma Labs
07 1Aspire Lifesciences Pvt Ltd
08 1Berr Chemical Company Ltd
09 1Biesterfeld Spezialchemie GmbH
10 1Biotechnica DWC
11 1ChemGenix Laboratories Pvt Ltd
12 1Cipla
13 2Debiopharm
14 1Desynth
15 1Emcure Pharmaceuticals
16 1Eriochem S.A.
17 1Fresenius Kabi AB Brunna
18 1Fresenius Kabi Oncology Limited
19 1Guangzhou Tosun Pharmaceutical
20 1Hangzhou Longshine Bio-Tech
21 1Hanways Chempharm
22 2Heraeus Holding
23 1Hetero Drugs
24 1Hospira, Inc.
25 1Hubei Haosun Pharmaceutical Co., Ltd.
26 1JARI Pharmaceutical
27 1Jeil Pharmaceutical Co., Ltd
28 2Jiangsu Hengrui Medicine
29 1Jiwan Pharmaceutical Technology Co., Ltd
30 1KUNMING GUIYAN PHARMACEUTICAL CO., LTD. CN 650 033 Kunming
31 1LIANYUNGANG JARI PHARMACEUTICAL CO., LTD.
32 2Laurus Labs
33 1Mac-Chem Products (India) Pvt.Ltd
34 1Nishchem International Pvt. Ltd
35 1Pliva Hrvatska
36 1Polymed Therapeutics Inc.
37 1Qilu Pharmaceutical
38 1Sakar Healthcare
39 1Shandong Boyuan Pharmaceutical
40 1Shilpa Medicare
41 1Sicor de Mexico
42 1Sun Pharmaceutical Industries Limited
43 1TANAKA KIKINZOKU KOGYO
44 1Teva Pharmaceutical Industries
45 2Umicore
46 1VUAB Pharma
47 1Vinkem Labs Ltd
48 1Zhejiang Hisun Pharmaceutical
49 1Zydus Lifesciences
01 1Algeria
02 2Argentina
03 15China
04 1Croatia
05 1Czech Republic
06 5Germany
07 17India
08 2Israel
09 1Japan
10 1Mexico
11 1South Korea
12 1Sweden
13 2Switzerland
14 4U.S.A
01 19Active
02 6Inactive
03 29Blank
01 2Expired
02 18Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 8Withdrawn by Holder
05 25Blank
01 1218MF10463
02 1220MF10123
03 1222MF10210
04 1224MF10217
05 1225MF10072
06 1225MF10121
07 1225MF10122
08 1227MF10151
09 46Blank
01 1WC-0041
02 1WC-0115
03 1WC-0148
04 1WC-0159
05 1WC-0177
06 1WC-0177A
07 1WC-0226
08 1WC-0275
09 46Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16952
Submission : 2003-11-11
Status : Active
Type : II
Registration Number : 220MF10123
Registrant's Address : 435 Devon Park Drive, Suite 400, Wayne, Pennsylvania 19087 USA
Initial Date of Registration : 2008-05-15
Latest Date of Registration : --
NDC Package Code : 49812-0075
Start Marketing Date : 2003-11-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (40kg/40kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sanofi-Aventis Korea Co., Ltd.
Registration Date : 2012-03-23
Registration Number : 20120323-197-I-32-03
Manufacturer Name : Veranova, LP
Manufacturer Address : 2003 Nolte Drive, West Deptford, NJ 08066, USA
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-24
Pay. Date : 2012-12-03
DMF Number : 19559
Submission : 2006-06-28
Status : Active
Type : II
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10040
Submission : 1993-01-15
Status : Active
Type : II
Registration Number : 218MF10463
Registrant's Address : 2-7-3 Marunouchi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2006-04-27
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-20
Pay. Date : 2014-03-07
DMF Number : 28043
Submission : 2014-03-08
Status : Active
Type : II
Certificate Number : R1-CEP 2010-002 - Rev 03
Issue Date : 2020-02-19
Type : Chemical
Substance Number : 2017
Status : Valid
Registration Number : 227MF10151
Registrant's Address : Calle 14, Nr. 229 (Lote 13), B1629MXA, Parque Industrial Pilar, Buenos Aires, Argentina
Initial Date of Registration : 2015-06-01
Latest Date of Registration : --
NDC Package Code : 72659-865
Start Marketing Date : 2018-01-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2019-04-04
Registration Number : 20180403-197-I-530-13(1)
Manufacturer Name : Umicore Argentina SA
Manufacturer Address : 14 Street No 229 - Pilar Industrial Park of the City of Pilar, Buenos Aires Province, of the Argentine Republic
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29430
Submission : 2015-05-13
Status : Active
Type : II
Certificate Number : CEP 2009-384 - Rev 03
Issue Date : 2024-08-08
Type : Chemical
Substance Number : 2017
Status : Valid
Registrant Name : Chong Kun Dang Co., Ltd.
Registration Date : 2014-03-10
Registration Number : 20131129-197-I-348-10(1)
Manufacturer Name : Kunming Guiyan Pharmaceutical Co., Ltd
Manufacturer Address : Kunming Institute of Precious Metals, No. 988, Keji Road, High-tech Development Zone, Kunming, Yunnan, China.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26267
Submission : 2012-07-30
Status : Active
Type : II
Certificate Number : R0-CEP 2011-395 - Rev 01
Issue Date : 2013-11-20
Type : Chemical
Substance Number : 2017
Status : Expired
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27762
Submission : 2013-12-13
Status : Inactive
Type : II
Certificate Number : R0-CEP 2014-037 - Rev 00
Issue Date : 2015-04-01
Type : Chemical
Substance Number : 2017
Status : Withdrawn by Holder
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