ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Shandong Chenghui Shuangda Pharmaceutical
03 1Transo-Pharm USA LLC
04 1LGM Pharma
05 2Aspen API
06 1Fareva
07 1Moehs Iberica
08 2Apothecon Pharmaceuticals
09 1Asence Pharma
10 1Biesterfeld Spezialchemie GmbH
11 3Biotechnica DWC
12 1CARBOGEN AMCIS AG
13 1Cerata Pharmaceuticals
14 1Dalian Richon Chem
15 4Dishman Carbogen Amcis
16 1Emcure Pharmaceuticals
17 1Fresenius Kabi AB Brunna
18 2Fresenius Kabi Oncology Limited
19 1Green Stone Swiss Co ., Ltd
20 1Guangzhou Tosun Pharmaceutical
21 1Harman Finochem
22 1Hebei AiYoung Pharmaceutical Technology
23 1Icrom
24 1Ishita API
25 1Jubilant Generics
26 1Mac-Chem Products (India) Pvt.Ltd
27 1Nanjing Bold Chemical
28 1Nantong Chem-land
29 2Pioneer Agro Extracts
30 1Qilu Pharmaceutical
31 1Qingdao Qingmei Biotech
32 1Recipharm AB
33 1Remedy Labs
34 1Shandong Anhong Pharmaceutical
35 1Shandong Boyuan Pharmaceutical
36 1Shouyuan Chemical
37 1Sms Lifesciences
38 1Surajlok Chemicals
39 1Swati Spentose
40 1Synteco S.p.A.
41 1Tecoland Corporation
42 1Xian Libang Pharmaceutical Co.,Ltd
43 1Yangtze River Pharmaceutical Group
01 3Algeria
02 14China
03 1Germany
04 21India
05 2Italy
06 1Luxembourg
07 2Netherlands
08 1Spain
09 2Sweden
10 1Switzerland
11 4U.S.A
01 13Active
02 3Inactive
03 36Blank
01 8Valid
02 3Withdrawn by Holder
03 41Blank
01 1305MF10079
02 51Blank
01 1SD230036
02 1WC-0108
03 1WC-0135
04 1WC-0135A
05 1WC-0174
06 1WC-0174a1
07 1WC-0181
08 1WC-0226
09 1WC-0275
10 1WC-0369n
11 1WC-0435
12 1WC-092
13 40Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-13
Pay. Date : 2013-08-05
DMF Number : 20249
Submission : 2007-02-02
Status : Active
Type : II
Certificate Number : R0-CEP 2022-198 - Rev 00
Issue Date : 2023-08-28
Type : Chemical
Substance Number : 2335
Status : Valid
Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.
Certificate Number : CEP 2023-148 - Rev 00
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 2335
Status : Valid
Date of Issue : 2023-05-30
Valid Till : 2026-05-29
Written Confirmation Number : SD230036
Address of the Firm :
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-19
Pay. Date : 2016-11-18
DMF Number : 20654
Submission : 2007-07-03
Status : Active
Type : II
Certificate Number : R1-CEP 2007-236 - Rev 03
Issue Date : 2023-01-13
Type : Chemical
Substance Number : 2335
Status : Valid
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-22
Pay. Date : 2013-05-01
DMF Number : 18288
Submission : 2005-04-15
Status : Active
Type : II
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-19
Pay. Date : 2021-04-23
DMF Number : 35568
Submission : 2021-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23239
Submission : 2009-11-02
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-19
Pay. Date : 2020-12-10
DMF Number : 35401
Submission : 2020-12-21
Status : Active
Type : II
Certificate Number : R1-CEP 2007-342 - Rev 03
Issue Date : 2021-07-15
Type : Chemical
Substance Number : 2335
Status : Valid
NDC Package Code : 66583-0610
Start Marketing Date : 1998-05-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36233
Submission : 2021-10-05
Status : Inactive
Type : II
Certificate Number : R0-CEP 2021-130 - Rev 00
Issue Date : 2021-09-14
Type : Chemical
Substance Number : 2335
Status : Valid
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