LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Suanfarma
03 1Gonane Pharma
04 1HRV Global Life Sciences
05 1Arihantanam Life Care
06 1Glenmark Life Sciences
07 1Glenmark Pharmaceuticals
08 1Hebei Shengxue Dacheng Pharmaceutical Co
09 1Kaliberr Labs
10 1Lianyungang Runzhong Pharmaceutical Co Ltd
11 2Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
12 1Mac-Chem Products (India) Pvt.Ltd
13 1Nippon Kayaku
14 1PROVENTUS LIFE SCIENCES PVT LTD
15 1Tecoland Corporation
16 1Tocopharm Co. Limited
17 2Xellia Pharmaceuticals ApS
01 5China
02 2Denmark
03 8India
04 1Japan
05 1Spain
06 2U.S.A
01 3Active
02 16Blank
01 5Valid
02 14Blank
01 1217MF10573
02 1221MF10198
03 1223MF10046
04 1303MF10108
05 15Blank
01 1WC-0275
02 1WC-0310
03 17Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13363
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 2000-209 - Rev 05
Issue Date : 2017-07-19
Type : Chemical
Substance Number : 319
Status : Valid
Registration Number : 221MF10198
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2009-09-14
Latest Date of Registration : --
NDC Package Code : 45932-0015
Start Marketing Date : 1998-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samchundang Pharmaceutical Co., Ltd.
Registration Date : 2020-12-17
Registration Number : 20200827-210-J-728(1)
Manufacturer Name : Xellia Pharmaceuticals ApS
Manufacturer Address : Dalslandsgade 11, 2300 Kobenhavn S, Denmark
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-12-29
Pay. Date : 2020-09-10
DMF Number : 35177
Submission : 2020-09-22
Status : Active
Type : II
Certificate Number : CEP 2019-246 - Rev 02
Issue Date : 2024-04-12
Type : Chemical
Substance Number : 319
Status : Valid
Registration Number : 303MF10108
Registrant's Address : No. 50 Shengxue Road, Luancheng Shijiazhuang, Hebei Province, China
Initial Date of Registration : 2021-07-16
Latest Date of Registration : --
NDC Package Code : 24507-005
Start Marketing Date : 2022-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2022-04-08
Registration Number : 20220408-210-J-1263
Manufacturer Name : Hebei Shengxue Dacheng Pharmaceutical Co., Ltd.
Manufacturer Address : No.50 Shengxue Road, Luancheng District, Shijiazhuang City, Hebei Province, PRChina
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-12
Pay. Date : 2019-05-16
DMF Number : 28350
Submission : 2014-05-30
Status : Active
Type : II
Certificate Number : R0-CEP 2018-085 - Rev 04
Issue Date : 2022-12-06
Type : Chemical
Substance Number : 319
Status : Valid
NDC Package Code : 42513-0007
Start Marketing Date : 2013-11-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20210325-210-J-908
Manufacturer Name : Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
Manufacturer Address : No. 8 Nangang Road, Jiangyin Industrial Concentration Zone, Fuqing, Fuzhou City, Fujian Province, PR China.
Date of Issue : 2023-12-28
Valid Till : 2026-12-28
Written Confirmation Number : WC-0310
Address of the Firm :
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2024-09-04
Registration Number : 20240904-210-J-1686
Manufacturer Name : Glenmark Life Sciences Ltd
Manufacturer Address : Plot No.Z-103/ I, DAHEJ SEZ Phase II, City : Dahej, District : Bharuch, Gujarat State, India
Certificate Number : R1-CEP 2015-189 - Rev 00
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 319
Status : Valid
Certificate Number : R1-CEP 2000-207 - Rev 06
Issue Date : 2023-04-04
Type : Chemical
Substance Number : 319
Status : Valid
Registration Number : 223MF10046
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2011-03-25
Latest Date of Registration : --
NDC Package Code : 45932-0015
Start Marketing Date : 1998-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samchundang Pharmaceutical Co., Ltd.
Registration Date : 2020-12-17
Registration Number : 20200827-210-J-728(1)
Manufacturer Name : Xellia Pharmaceuticals ApS
Manufacturer Address : Dalslandsgade 11, 2300 Kobenhavn S, Denmark
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