LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Aspen API
03 1Bachem AG
04 1Inabata France S.A.S
05 1HRV Global Life Sciences
06 1Omgene Life Sciences Pvt. Ltd
07 1ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
08 1Apino Pharma
09 2Auro Peptides Limited
10 1Aurobindo Pharma Limited
11 1BCN Peptides
12 1Ferring Pharmaceuticals
13 1Fujifilm Diosynth Biotechnologies
14 1Hybio Pharmaceutical
15 1Jin Dun Medical
16 2Lonza Group
17 1Mallinckrodt Pharmaceuticals
18 1Piramal Pharma Solutions
19 3PolyPeptide Group
20 1ScinoPharm Taiwan, Ltd
21 1Shenzhen JYMed Technology
22 1Shilpa Medicare
23 2Sinopep Pharmaceutical Inc
24 1Smaart Pharmaceutticals
25 1Sun Pharmaceutical Industries Limited
26 1TAPI Technology & API Services
27 1Teva Pharmaceutical Industries
28 1Viatris
29 2Blank
01 7China
02 1France
03 8India
04 1Ireland
05 2Israel
06 1Netherlands
07 1Spain
08 7Switzerland
09 1Taiwan
10 3U.S.A
11 1United Kingdom
12 2Blank
01 13Active
02 8Inactive
03 14Blank
01 1Expired
02 11Valid
03 3Withdrawn by Holder
04 20Blank
01 1224MF10122
02 1226MF10051
03 1306MF10047
04 32Blank
01 1WC-0118
02 1WC-0159
03 1WC-0237
04 1WC-0443
05 1WC-0443-A1-2
06 30Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10175
Submission : 1993-03-30
Status : Active
Type : II
Certificate Number : R1-CEP 1999-165 - Rev 05
Issue Date : 2016-03-31
Type : Chemical
Substance Number : 712
Status : Valid
NDC Package Code : 60870-0440
Start Marketing Date : 1999-07-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-31
Pay. Date : 2014-03-27
DMF Number : 9951
Submission : 1992-11-05
Status : Active
Type : II
Certificate Number : R1-CEP 2007-157 - Rev 02
Issue Date : 2023-06-29
Type : Chemical
Substance Number : 712
Status : Valid
Registration Number : 226MF10051
Registrant's Address : 3132 Kashiwa Street, Torrance, California 90505, USA
Initial Date of Registration : 2014-02-27
Latest Date of Registration : --
NDC Package Code : 52416-108
Start Marketing Date : 2001-09-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : EXPORT ONLY
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-03-30
Pay. Date : 2016-02-17
DMF Number : 30233
Submission : 2016-02-19
Status : Active
Type : II
Certificate Number : R1-CEP 2016-125 - Rev 01
Issue Date : 2023-03-31
Type : Chemical
Substance Number : 712
Status : Valid
Date of Issue : 2019-06-11
Valid Till : 2022-06-11
Written Confirmation Number : WC-0443
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-15
Pay. Date : 2012-11-23
DMF Number : 22324
Submission : 2008-12-19
Status : Active
Type : II
NDC Package Code : 65129-1157
Start Marketing Date : 2005-09-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-16
Pay. Date : 2013-12-06
DMF Number : 22871
Submission : 2009-06-16
Status : Active
Type : II
Certificate Number : R1-CEP 2009-087 - Rev 02
Issue Date : 2022-10-04
Type : Chemical
Substance Number : 712
Status : Valid
Date of Issue : 2019-09-03
Valid Till : 2022-09-02
Written Confirmation Number : WC-0237
Address of the Firm :
NDC Package Code : 41701-007
Start Marketing Date : 2011-03-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10g/10g)
Marketing Category : BULK INGREDIENT
Registrant Name : Sampoong Finechem Co., Ltd.
Registration Date : 2022-05-11
Registration Number : 20210628-209-J-1042(1)
Manufacturer Name : Piramal Pharma Limited
Manufacturer Address : Plot No C-43, MIDC, TTC Industrial Area, Turbhe, Off Thane Belapur Road, Navi Mumbai Thane-400703 Maharashtra State, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8093
Submission : 1989-06-07
Status : Inactive
Type : II
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