ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1LGM Pharma
03 1Rochem International Inc
04 1Dr. Reddy's Laboratories
05 1HRV Global Life Sciences
06 1Apothecon Pharmaceuticals
07 1Aspen Biopharma Labs
08 1Aurobindo Pharma Limited
09 1Bioindustria L.I.M. Spa
10 1Biotechnica DWC
11 1GLAND PHARMA LIMITED
12 1Glenmark Life Sciences
13 1Glenmark Pharmaceuticals
14 1Hangzhou Jiuyuan Gene Engineering
15 1Hetero Drugs
16 1Lianyungang Runzhong Pharmaceutical Co Ltd
17 1Lunan Pharmaceutical
18 2MSN Laboratories
19 1Mac-Chem Products (India) Pvt.Ltd
20 1Piramal Pharma Solutions
21 1Qilu Pharmaceutical
22 1Qilu Tianhe Pharmaceutical Co., Ltd.
23 1Sailong Pharmaceutical
24 1Sakar Healthcare
25 1ScinoPharm Taiwan, Ltd
26 1Shenzhen Haorui
27 1Sms Lifesciences
28 1Tecoland Corporation
29 1Vitalpharms
30 1Viwit Pharmaceuticals Limited
31 2Wisdom Pharmaceutical
32 1Wockhardt
33 1Blank
01 1Algeria
02 11China
03 15India
04 1Italy
05 1Taiwan
06 5U.S.A
07 1Blank
01 15Active
02 1Inactive
03 19Blank
01 35Blank
01 1302MF10083
02 1304MF10040
03 1305MF10071
04 32Blank
01 1WC-0017
02 1WC-0021
03 1WC-0021n
04 1WC-0040
05 1WC-0057n
06 1WC-0123
07 29Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-08-08
Pay. Date : 2023-07-05
DMF Number : 38210
Submission : 2023-03-28
Status : Active
Type : II
NDC Package Code : 71796-038
Start Marketing Date : 2023-03-28
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 : 33558
Submission : 2019-04-11
Status : Active
Type : II
Registration Number : 305MF10071
Registrant's Address : 369 Shengong Road, Zaozhuang High-tech Park, Shandong, China
Initial Date of Registration : 2023-06-07
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-20
Pay. Date : 2017-06-15
DMF Number : 31484
Submission : 2017-03-20
Status : Active
Type : II
Registration Number : 302MF10083
Registrant's Address : Digwal Village (Sy.Nos. 7-70, 70/1 and 70/2), Kohir Mandal, Sangareddy District-502 321, Telangana, India
Initial Date of Registration : 2020-07-16
Latest Date of Registration : --
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0123
Address of the Firm :
NDC Package Code : 65085-0060
Start Marketing Date : 2016-09-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-20
Pay. Date : 2016-09-22
DMF Number : 30973
Submission : 2017-07-17
Status : Active
Type : II
NDC Package Code : 65129-1322
Start Marketing Date : 2021-02-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-16
Pay. Date : 2012-11-23
DMF Number : 25682
Submission : 2012-01-06
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0064
Start Marketing Date : 2011-10-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-02-25
Pay. Date : 2016-01-14
DMF Number : 30137
Submission : 2015-12-31
Status : Active
Type : II
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