ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1LGM Pharma
04 1Veranova
05 13M Company
06 1Amphastar Pharmaceuticals
07 1Aurobindo Pharma Limited
08 2Azico Biophore India Pvt. Ltd
09 1Boehringer Ingelheim GmbH
10 1CiVentiChem, LLC
11 1Cilag AG
12 1Deva Holding AS
13 1Emcure Pharmaceuticals
14 1GLAND PHARMA LIMITED
15 1Guangzhou Tosun Pharmaceutical
16 1Harman Finochem
17 1Hetero Drugs
18 1Hospira, Inc.
19 1Hunan Warrant Chiral Pharmaceutical
20 1Medinex Laboratories
21 1Micro Labs Limited
22 1Olon S.p.A
23 1Recipharm AB
24 1SKVen Technologies Pvt. Ltd
25 1Sai Life Sciences Limited
26 1Shenzhen Oriental Pharmaceutical
27 1Shiono Finesse
28 1Sunny Pharmtech
29 1Wuhan Wuyao Pharmaceutical
30 2Blank
01 4China
02 1Germany
03 12India
04 1Italy
05 1Japan
06 1Sweden
07 1Switzerland
08 1Taiwan
09 1Turkey
10 7U.S.A
11 2Blank
01 13Active
02 6Inactive
03 13Blank
01 4Valid
02 28Blank
01 1220MF10065
02 31Blank
01 1WC-0044
02 1WC-0225A7
03 1WC-0279
04 1WC-0404
05 1WC-0404A2
06 1WC-0427A3-4
07 26Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-11-29
Pay. Date : 2016-09-15
DMF Number : 30652
Submission : 2016-09-15
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-10-06
Pay. Date : 2016-08-22
DMF Number : 30811
Submission : 2016-08-13
Status : Active
Type : II
Certificate Number : R1-CEP 2017-180 - Rev 00
Issue Date : 2023-07-05
Type : Chemical
Substance Number : 1332
Status : Valid
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-02-14
Pay. Date : 2018-01-18
DMF Number : 32151
Submission : 2017-10-18
Status : Active
Type : II
Certificate Number : R0-CEP 2022-154 - Rev 00
Issue Date : 2023-07-21
Type : Chemical
Substance Number : 1332
Status : Valid
NDC Package Code : 14593-921
Start Marketing Date : 2022-02-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31927
Submission : 2018-07-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-07-26
Pay. Date : 2017-05-31
DMF Number : 31569
Submission : 2017-05-15
Status : Active
Type : II
Certificate Number : CEP 2022-088 - Rev 00
Issue Date : 2024-05-15
Type : Chemical
Substance Number : 1332
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-07
Pay. Date : 2019-04-17
DMF Number : 33445
Submission : 2019-02-28
Status : Active
Type : II
Date of Issue : 2022-08-04
Valid Till : 2025-03-04
Written Confirmation Number : WC-0427A3-4
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-23
Pay. Date : 2015-09-28
DMF Number : 29732
Submission : 2015-09-28
Status : Active
Type : II
Date of Issue : 2020-06-23
Valid Till : 2022-08-15
Written Confirmation Number : WC-0225A7
Address of the Firm :
NDC Package Code : 42571-285
Start Marketing Date : 2015-09-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-04-07
Pay. Date : 2022-03-03
DMF Number : 36634
Submission : 2022-05-12
Status : Active
Type : II
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