Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Dr. Reddy's Laboratories
03 1Moehs Iberica
04 1Aarti Pharmalabs
05 1Neuland Laboratories
06 1USV Private Limited
07 1Aurisco Pharmaceutical
08 1Changzhou Pharmaceutical Factory
09 1Chengda Pharmaceuticals
10 1Formosa Laboratories
11 1Glenmark Life Sciences
12 1Hetero Drugs
13 1Lunan Pharmaceutical
14 1Lupin Ltd
15 1MSN Laboratories
16 1Optimus Pharma
17 1ScinoPharm Taiwan, Ltd
18 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
19 1Sun Pharmaceutical Industries Limited
20 1Teva Pharmaceutical Industries
21 1Zhejiang Huahai Pharmaceutical
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-15
Pay. Date : 2022-03-30
DMF Number : 36646
Submission : 2021-12-30
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-26
Pay. Date : 2021-12-17
DMF Number : 35473
Submission : 2021-01-22
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38220
Submission : 2023-03-27
Status :
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 :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36947
Submission : 2022-03-31
Status :
Type : II
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40326
Submission : 2024-09-30
Status :
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.
A Elagolix DMF (Drug Master File) is a document detailing the whole manufacturing process of Elagolix active pharmaceutical ingredient (API) in detail. Different forms of Elagolix DMFs exist exist since differing nations have different regulations, such as Elagolix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Elagolix DMF submitted to regulatory agencies in the US is known as a USDMF. Elagolix USDMF includes data on Elagolix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Elagolix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Elagolix suppliers with USDMF on PharmaCompass.
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