ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Polpharma
03 1Biophore India Pharmaceuticals Pvt Ltd
04 1Aspen API
05 1Metrochem API Private Limited
06 1Dr. Reddy's Laboratories
07 1Moehs Iberica
08 1Aarti Pharmalabs
09 1Neuland Laboratories
10 1Shandong Loncom Pharmaceutical
11 1USV Private Limited
12 1Atomgrid
13 1Aurisco Pharmaceutical
14 1Beijing Hope Pharmaceutical
15 1Beijing Sjar Technology Development
16 1Brother Enterprises Holding
17 1Cdymax
18 1Changzhou Pharmaceutical Factory
19 1Chengda Pharmaceuticals
20 1Formosa Laboratories
21 1Fuan Pharmaceutical
22 1Fujian South Pharmaceutical
23 1Glenmark Life Sciences
24 1Glenmark Pharmaceuticals
25 1Hetero Drugs
26 1Jubilant Generics
27 1Lee Pharma
28 1Lunan Pharmaceutical
29 1Lupin Ltd
30 1MSN Laboratories
31 1Olon S.p.A
32 1Optimus Pharma
33 1SMS Pharmaceuticals
34 1ScinoPharm Taiwan, Ltd
35 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
36 1Sichuan Renan Pharmaceutical
37 1Sun Pharmaceutical Industries Limited
38 1Teva API
39 1Teva Pharmaceutical Industries
40 1UQUIFA
41 1Zhejiang Huahai Pharmaceutical
42 1Zhejiang Tianyu Pharmaceutical Co., Ltd
01 14China
02 18India
03 2Israel
04 1Italy
05 1Netherlands
06 1Poland
07 2Spain
08 2Taiwan
09 1U.S.A
01 21Active
02 21Blank
01 42Blank
01 42Blank
01 1WC-390A4
02 41Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-04-15
Pay. Date : 2022-03-30
DMF Number : 36646
Submission : 2021-12-30
Status : Active
Type : II
NDC Package Code : 73435-021
Start Marketing Date : 2021-12-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-01-26
Pay. Date : 2021-12-17
DMF Number : 35473
Submission : 2021-01-22
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-11-30
Written Confirmation Number : WC-390A4
Address of the Firm :
NDC Package Code : 71796-025
Start Marketing Date : 2020-12-23
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 : 38220
Submission : 2023-03-27
Status : Active
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36636
Submission : 2022-02-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36947
Submission : 2022-03-31
Status : Active
Type : II
NDC Package Code : 58032-1028
Start Marketing Date : 2022-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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