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 1Metrochem API Private Limited
05 1Dr. Reddy's Laboratories
06 1Moehs Iberica
07 1Aarti Pharmalabs
08 1Neuland Laboratories
09 1Shandong Loncom Pharmaceutical
10 1USV Private Limited
11 1TAPI Technology & API Services
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 1Livmore Life Sciences
29 1Lunan Pharmaceutical
30 1Lupin Ltd
31 1MSN Laboratories
32 1Optimus Pharma
33 1Raghava Life Sciences
34 1SMS Pharmaceuticals
35 1ScinoPharm Taiwan, Ltd
36 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
37 1Sichuan Renan Pharmaceutical
38 1Sun Pharmaceutical Industries Limited
39 1Teva Pharmaceutical Industries
40 1UQUIFA
41 1Zhejiang Huahai Pharmaceutical
42 1Zhejiang Tianyu Pharmaceutical Co., Ltd
01 14China
02 20India
03 2Israel
04 1Poland
05 2Spain
06 2Taiwan
07 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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40326
Submission : 2024-09-30
Status : Active
Type : II
A Elagolix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elagolix, including repackagers and relabelers. The FDA regulates Elagolix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elagolix API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Elagolix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Elagolix supplier is an individual or a company that provides Elagolix active pharmaceutical ingredient (API) or Elagolix finished formulations upon request. The Elagolix suppliers may include Elagolix API manufacturers, exporters, distributors and traders.
click here to find a list of Elagolix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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