DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 2Fermion Oy
03 1Cohance Lifesciences
04 1IOL Chemicals and Pharmaceuticals
05 1Moehs Iberica
06 1Aarti Pharmalabs
07 1Medichem S.A
08 1TAPI Technology & API Services
09 1Alembic Pharmaceuticals Limited
10 1Alkem Laboratories
11 2Aurobindo Pharma Limited
12 1Cambrex Corporation
13 1Chemeca Drugs
14 1Cipla
15 1CordenPharma
16 1Dishman Carbogen Amcis
17 1Divis Laboratories
18 2F.I.S. Fabbrica Italiana Sintetici
19 3Hetero Drugs
20 1Hikal
21 2Ind Swift Laboratories Limited
22 1Indoco Remedies Limited
23 1Ipca Laboratories
24 2Jubilant Generics
25 1Lupin Ltd
26 1Macleods Pharmaceuticals Limited
27 1Megafine Pharma (P) Limited
28 1Menadiona
29 1Olon S.p.A
30 1Orchid Pharma
31 1Par Pharmaceutical
32 1Piramal Pharma Solutions
33 1Raks Pharma
34 2Sun Pharmaceutical Industries Limited
35 1Suzhou no. 4 Pharmaceutical Factory
36 1Teva Pharmaceutical Industries
37 1Torrent Pharmaceuticals Limited
38 2UQUIFA
39 2Unichem Laboratories Limited
40 1Vasudha Pharma Chem
41 1Viatris
42 1Wanbury Limited
43 1Zhejiang Apeloa Jiayuan Pharmaceutical
44 1Zhejiang Hisun Pharmaceutical
45 1Zhejiang Huahai Pharmaceutical
46 2Zhejiang Supor Pharmaceuticals Co., LTD
47 1Zydus Lifesciences
48 1Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17122
Submission : 2004-01-29
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19160
Submission : 2006-02-02
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-01
Pay. Date : 2017-10-18
DMF Number : 32085
Submission : 2017-10-03
Status :
Type : II
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37105
Submission : 2023-03-22
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 : 24541
Submission : 2011-01-07
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 : 21336
Submission : 2008-02-12
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-25
Pay. Date : 2014-12-05
DMF Number : 28833
Submission : 2014-12-05
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 18341
Submission : 2005-05-09
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25954
Submission : 2011-10-26
Status :
Type : II
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A Quetiapine Hemifumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quetiapine Hemifumarate, including repackagers and relabelers. The FDA regulates Quetiapine Hemifumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quetiapine Hemifumarate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Quetiapine Hemifumarate supplier is an individual or a company that provides Quetiapine Hemifumarate active pharmaceutical ingredient (API) or Quetiapine Hemifumarate finished formulations upon request. The Quetiapine Hemifumarate suppliers may include Quetiapine Hemifumarate API manufacturers, exporters, distributors and traders.
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A Quetiapine Hemifumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Quetiapine Hemifumarate active pharmaceutical ingredient (API) in detail. Different forms of Quetiapine Hemifumarate DMFs exist exist since differing nations have different regulations, such as Quetiapine Hemifumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Quetiapine Hemifumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Quetiapine Hemifumarate USDMF includes data on Quetiapine Hemifumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quetiapine Hemifumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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