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 1Alchymars ICM SM
04 1Amphastar Pharmaceuticals
05 1Apothecon Pharmaceuticals
06 1Aurobindo Pharma Limited
07 2Azico Biophore India Pvt. Ltd
08 1ChemCon GmbH
09 1CiVentiChem, LLC
10 1Emcure Pharmaceuticals
11 1Guangzhou Tosun Pharmaceutical
12 1Hainan Poly Pharm
13 1Hospira, Inc.
14 1Hunan Warrant Chiral Pharmaceutical
15 1Interquim Mexico
16 1Micro Labs Limited
17 1Sun Pharmaceutical Industries Limited
18 1Tecoland Corporation
19 1Trifarma
20 1Viatris
01 3China
02 1Germany
03 9India
04 1Italy
05 1Mexico
06 6U.S.A
01 13Active
02 1Inactive
03 7Blank
01 1Valid
02 20Blank
01 21Blank
01 1WC-0225
02 1WC-0404
03 1WC-0404A2
04 18Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-09-02
Pay. Date : 2015-09-21
DMF Number : 29723
Submission : 2015-09-30
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 : 2016-03-08
Pay. Date : 2015-09-29
DMF Number : 29647
Submission : 2015-09-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-11-06
Pay. Date : 2018-09-11
DMF Number : 33023
Submission : 2018-09-06
Status : Active
Type : II
Certificate Number : R0-CEP 2020-114 - Rev 01
Issue Date : 2022-03-14
Type : Chemical
Substance Number : 565
Status : Valid
NDC Package Code : 14335-130
Start Marketing Date : 2021-12-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-11-22
Pay. Date : 2016-08-29
DMF Number : 30849
Submission : 2016-09-13
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-11
Pay. Date : 2015-09-08
DMF Number : 29694
Submission : 2015-09-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-27
Pay. Date : 2016-12-27
DMF Number : 31262
Submission : 2017-01-02
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-15
Pay. Date : 2015-07-15
DMF Number : 29156
Submission : 2015-07-14
Status : Active
Type : II
Date of Issue : 2019-08-16
Valid Till : 2022-08-15
Written Confirmation Number : WC-0225
Address of the Firm :
NDC Package Code : 42571-283
Start Marketing Date : 2021-04-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-10
Pay. Date : 2014-07-07
DMF Number : 27812
Submission : 2013-12-27
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-26
Pay. Date : 2014-06-06
DMF Number : 27468
Submission : 2014-05-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4692
Submission : 1982-10-22
Status : Inactive
Type : II
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