ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Minakem
03 1Minakem (formerly Delmar Chemicals)
04 1LGM Pharma
05 1Inabata France S.A.S
06 1Rochem International Inc
07 1Granules India Limited
08 1ALP Pharm
09 1Angels Pharma India Private Limited
10 2BDR Lifesciences
11 1Biotechnica DWC
12 1Cambrex Corporation
13 1Chengda Pharmaceuticals
14 1Formosa Laboratories
15 1Guangzhou Tosun Pharmaceutical
16 1Hetero Drugs
17 1Hunan Huateng Pharmaceutical Co ltd
18 1Jin Dun Medical
19 1Kekule Pharma
20 1MSN Laboratories
21 1Mac-Chem Products (India) Pvt.Ltd
22 1Nantong Chem-land
23 1Natco Pharma
24 1Sakar Healthcare
25 1ScinoPharm Taiwan, Ltd
26 1Shandong Boyuan Pharmaceutical
27 1Sichuan Xieli Pharmaceutical
28 1Sumar Biotech
29 1Vannsh Life Sciences
01 1Algeria
02 1Canada
03 8China
04 2France
05 12India
06 2Taiwan
07 4U.S.A
01 9Active
02 1Inactive
03 20Blank
01 30Blank
01 1304MF10087
02 29Blank
01 1WC-0041
02 1WC-0340A3
03 1WC-0349
04 1WC-0484
05 1WC-340n
06 25Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34836
Submission : 2021-02-05
Status : Active
Type : II
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-12-03
Pay. Date : 2018-01-24
DMF Number : 32266
Submission : 2018-01-17
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36602
Submission : 2022-01-24
Status : Active
Type : II
NDC Package Code : 62207-980
Start Marketing Date : 2023-07-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35214
Submission : 2021-02-27
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0110
Start Marketing Date : 2021-02-27
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 : 30043
Submission : 2015-12-04
Status : Active
Type : II
NDC Package Code : 54245-7005
Start Marketing Date : 2015-01-05
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 : 26465
Submission : 2012-09-20
Status : Inactive
Type : II
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