LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Seqens
03 1Cohance Lifesciences
04 1Rusan Pharma
05 1HRV Global Life Sciences
06 1Nortec Quimica
07 1Supriya Lifescience
08 1Abbott Laboratories
09 1Cambrex Corporation
10 1Centaur Pharmaceuticals
11 1F.I.S. Fabbrica Italiana Sintetici
12 1Formil Quimica Ltd
13 1Fujifilm Diosynth Biotechnologies
14 1Global Calcium
15 1Hameln rds
16 1IIQUIAP
17 1Jiangsu Nhwa Pharmaceutical
18 1Lake Chemicals
19 1OmnisMed Pharmaceuticals
20 1Precise Group
21 1R L Fine Chem
22 1RANBAXY LABORATORIES LIMITED
23 1Resonance Laboratories Pvt. Ltd
24 1Solara Active Pharma Sciences
25 1Sun Pharmaceutical Industries Limited
26 1Unipex
01 2Brazil
02 1China
03 2France
04 13India
05 1Italy
06 1Mexico
07 1Slovakia
08 3U.S.A
09 2United Kingdom
01 5Active
02 3Inactive
03 18Blank
01 6Valid
02 1Withdrawn by Holder
03 19Blank
01 1219MF10137
02 1221MF10248
03 1223MF10029
04 1229MF10108
05 22Blank
01 1WC-0011nA2
02 1WC-0101
03 1WC-0107
04 1WC-0150
05 22Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-05
Pay. Date : 2013-05-22
DMF Number : 12553
Submission : 1997-06-18
Status : Active
Type : II
Certificate Number : CEP 2006-267 - Rev 08
Issue Date : 2024-10-23
Type : Chemical
Substance Number : 936
Status : Valid
Registration Number : 221MF10248
Registrant's Address : Offer Park, Building C, 4th floor, 94 Shlomo Shmeltzer Road, POB 3158, Petah Tikva 4970602, Israel
Initial Date of Registration : 2009-11-17
Latest Date of Registration : --
NDC Package Code : 58175-0350
Start Marketing Date : 2001-02-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2021-03-23
Registration Number : 20210323-210-J-612
Manufacturer Name : Wavelength Enterprises LTD.
Manufacturer Address : Neot Hovav Eco-Industrial Park, POB 3593, Be'er Sheva 8413502, Israel
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-03
Pay. Date : 2015-02-12
DMF Number : 26871
Submission : 2013-02-04
Status : Active
Type : II
Certificate Number : R1-CEP 2010-141 - Rev 02
Issue Date : 2022-12-15
Type : Chemical
Substance Number : 936
Status : Valid
Date of Issue : 2022-07-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0150
Address of the Firm :
NDC Package Code : 17511-115
Start Marketing Date : 2020-01-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20210325-210-J-815
Manufacturer Name : Cohance Lifesciences Limited
Manufacturer Address : RS 50/1, Mukteswarapuram Village, Jaggaiahpeta Mandal, NTR District-521 457, Andhra Pradesh, India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39365
Submission : 2024-03-14
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-18
Pay. Date : 2014-04-10
DMF Number : 12686
Submission : 1997-10-06
Status : Active
Type : II
Certificate Number : R1-CEP 2006-025 - Rev 03
Issue Date : 2017-07-28
Type : Chemical
Substance Number : 936
Status : Valid
Registration Number : 223MF10029
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2011-02-25
Latest Date of Registration : --
NDC Package Code : 12828-0069
Start Marketing Date : 1996-10-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 12910
Submission : 1998-03-23
Status : Inactive
Type : II
Certificate Number : R0-CEP 1998-114 - Rev 01
Issue Date : 2002-04-12
Type : Chemical
Substance Number : 936
Status : Withdrawn by Holder
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