ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Nuray Chemicals Private Limited
03 1Rochem International Inc
04 1ACS DOBFAR SPA
05 1Abbott Laboratories
06 1Alchymars ICM SM
07 1American Chemical Products
08 1Aurobindo Pharma Limited
09 1Chongqing Carelife Pharmaceutical
10 1Concord Biotech
11 1Esteve Quimica
12 1GREAT-5 INTERNATIONAL INC
13 1Hangzhou Think Chemical Co.Ltd
14 1Hengdian Group
15 2Hubei Yitai Pharmaceutical Co. , Ltd.
16 1Nanyang Pukang Pharmaceutical Co., Ltd.
17 1Pfizer Inc
18 2Suzhou no. 4 Pharmaceutical Factory
19 1Trifarma
20 1UQUIFA
21 1Unipex
22 1Xinyu Pharmaceutical
23 1Zhejiang Hisoar Pharmaceutical
24 1Zhejiang Tiantai Pharmaceutical
25 1Zydus Lifesciences
26 2Blank
01 1Canada
02 11China
03 1France
04 5India
05 2Italy
06 2Spain
07 5U.S.A
08 2Blank
01 8Active
02 10Inactive
03 11Blank
01 8Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 20Blank
01 1303MF10077
02 28Blank
01 1WC-0023
02 1WC-0348
03 27Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-04-09
Pay. Date : 2018-01-31
DMF Number : 32342
Submission : 2018-01-08
Status : Active
Type : II
Certificate Number : R0-CEP 2022-223 - Rev 00
Issue Date : 2023-08-21
Type : Chemical
Substance Number : 582
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-06-13
Pay. Date : 2018-04-19
DMF Number : 31876
Submission : 2017-08-01
Status : Active
Type : II
Certificate Number : CEP 2024-319 - Rev 00
Issue Date : 2024-09-23
Type : Chemical
Substance Number : 582
Status : Valid
NDC Package Code : 69132-002
Start Marketing Date : 2017-09-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-28
Pay. Date : 2016-07-14
DMF Number : 20450
Submission : 2007-03-28
Status : Active
Type : II
Certificate Number : CEP 2010-281 - Rev 04
Issue Date : 2024-03-14
Type : Chemical
Substance Number : 582
Status : Valid
NDC Package Code : 39635-0002
Start Marketing Date : 2014-03-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-06
Pay. Date : 2013-07-09
DMF Number : 27266
Submission : 2013-07-08
Status : Active
Type : II
Certificate Number : CEP 2013-190 - Rev 02
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 582
Status : Valid
Registration Number : 303MF10077
Registrant's Address : No. 23,5th Donghai Avenue Zhejiang Chemical materials base Linhai zone, Linhai City, Zhejiang Province, China.
Initial Date of Registration : 2021-05-13
Latest Date of Registration : --
NDC Package Code : 67321-301
Start Marketing Date : 2015-02-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2021-04-16
Registration Number : 20210416-210-J-619
Manufacturer Name : Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd.@HEC PHARM CO., LTD
Manufacturer Address : No. 23 Donghai 5th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Linhai City, Zhejiang Province China@No.3 Industrial Park of HEC, Yidu, Hubei Province, PR China
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-26
Pay. Date : 2013-09-24
DMF Number : 20971
Submission : 2007-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7289
Submission : 1988-01-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14539
Submission : 1999-11-18
Status : Inactive
Type : II
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