 LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
 
										

 
				
									 
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01 1LGM Pharma
02 1Rochem International Inc
03 1DKSH
04 1HRV Pharma
05 1Maithri Drugs
06 1Anwita Drugs
07 2Changzhou Pharmaceutical Factory
08 1Darmerica
09 1GLAND PHARMA LIMITED
10 1Gurvey & Berry
11 1HUASHU PHARMACEUTICAL CORPORATION
12 1Hebei Dongfeng Pharmaceutical Co., Ltd
13 1Hema Pharma
14 2Hovione
15 2Kaifeng Pharmaceutical Group Co., Ltd
16 1Kalchem International
17 1Kunshan Chemical & Pharmaceutical Co.Ltd
18 1Letco Medical
19 1Medisca
20 1Nanjing Dorra Pharmaceutical Technology Co.,Ltd
21 2Pcca
22 4Pfizer Inc
23 1Qingdao Qingmei Biotech
24 1Qualite Pharma
25 1Raks Pharma
26 1Sandoz B2B
27 2Shandong Guobang Pharmaceutical
28 1Shanghai International Pharmaceutical Trading
29 1Spansules Pharma
30 1Sun Pharmaceutical Industries Limited
31 1Willow Birch Pharma
32 2Yancheng Suhai Pharmaceutical Co
33 1Yangzhou Liberty Pharmaceutical
34 1Yangzhou Pharmaceutical
35 1Yichang Sanxia Pharmaceutical
36 1Zim Laboratories
37 1Zydus Lifesciences
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01 1Canada
02 17China
03 11India
04 2Portugal
05 2Switzerland
06 11U.S.A
07 2United Kingdom
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01 9Active
02 11Inactive
03 28Blank
01 7Valid
02 2Withdrawn by EDQM Failure to CEP procedure
03 2Withdrawn by Holder
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01 1224MF10204
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01 1WC-0305
02 1WC-0427
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01 120110630-101-F-59-02
02 120220527-101-F-98-05
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01 138779-0434
02 143457-541
03 147621-018
04 150909-8105
05 151927-0130
06 151927-3129
07 155018-151
08 155488-0100
09 160592-201
10 160715-0445
11 162991-2572
12 167698-101
13 170846-420
14 171052-030
15 34Blank
01 15394
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 LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
 Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41689
Submission : 2025-03-30
Status : Active
Type : II
 
											 
												GDUFA
DMF Review : Reviewed
Rev. Date : 2022-11-16
Pay. Date : 2022-09-29
DMF Number : 36491
Submission : 2021-11-11
Status : Active
Type : II
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2011-06-30
Registration Number : 20110630-101-F-59-02
Manufacturer Name : Yancheng Suhai Pharmaceutical Co., Ltd
Manufacturer Address : No. 92 E.Jiankang Road, Dafeng City, Jiangsu, China

 
											 
												GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18004
Submission : 2005-01-13
Status : Inactive
Type : II
Certificate Number : R0-CEP 2003-225 - Rev 00
Issue Date : 2005-04-15
Type : Chemical
Substance Number : 272
Status : Withdrawn by EDQM F...

 
											 
												GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16191
Submission : 2002-09-24
Status : Inactive
Type : II
Certificate Number : CEP 1999-100 - Rev 06
Issue Date : 2025-08-25
Type : Chemical
Substance Number : 272
Status : Valid
NDC Package Code : 67698-101
Start Marketing Date : 2015-09-05
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER, FOR SUSPENSION (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-05-27
Registration Number : 20220527-101-F-98-05
Manufacturer Name : Yancheng Suhai Pharmaceutical Co.,Ltd
Manufacturer Address : Huafeng Industrial Park, Dafeng Port Economic Development Zone, Dafeng District, Yancheng City, Jiangsu Province, China

 
											 
												GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12864
Submission : 1998-02-17
Status : Inactive
Type : II
Certificate Number : R1-CEP 2001-038 - Rev 02
Issue Date : 2015-03-19
Type : Chemical
Substance Number : 272
Status : Valid

 
											 
												GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17094
Submission : 2004-01-14
Status : Inactive
Type : II

56
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A Vivox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vivox, including repackagers and relabelers. The FDA regulates Vivox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vivox API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Vivox supplier is an individual or a company that provides Vivox active pharmaceutical ingredient (API) or Vivox finished formulations upon request. The Vivox suppliers may include Vivox API manufacturers, exporters, distributors and traders.
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