DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2Dr. Reddy's Laboratories
02 1Metrochem API Private Limited
03 2Neuland Laboratories
04 1TAPI Technology & API Services
05 1Lee Pharma
06 1Sichuan Qingmu Pharmaceutical
07 1Acebright India Pharma Private Limited
08 1Alembic Pharmaceuticals Limited
09 2Alivus Life Sciences
10 1Apotex Pharmachem
11 1Aurobindo Pharma Limited
12 1Aurore Life Sciences
13 1Biocon
14 1Changzhou Pharmaceutical Factory
15 1Esteve Quimica
16 1Hetero Drugs
17 2Hikal
18 1Hisun Pharmaceutical Nantong
19 1Intas Pharmaceuticals
20 1Jiangxi Synergy Pharmaceutical
21 1Jubilant Generics
22 1Lupin Ltd
23 2MSN Laboratories
24 1Micro Labs Limited
25 1Optimus Pharma
26 1Piramal Pharma Solutions
27 1Sichuan Renan Pharmaceutical
28 1Solara Active Pharma Sciences
29 1Srini Pharmaceuticals
30 1Sun Pharmaceutical Industries Limited
31 1Yabao Pharmaceutical Group Co. Ltd
32 1Zhejiang Huahai Pharmaceutical
33 1Zydus Lifesciences
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-07
Pay. Date : 2014-04-21
DMF Number : 27960
Submission : 2014-04-04
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37633
Submission : 2022-10-31
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28352
Submission : 2014-07-07
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 : 2014-07-15
Pay. Date : 2014-04-22
DMF Number : 28118
Submission : 2014-04-27
Status :
Type : II
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36181
Submission : 2021-11-17
Status :
Type : II
Sichuan Qingmu Pharmaceutical offers reliable CDMO support and high-quality APIs for regulated markets.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36539
Submission : 2021-12-29
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2025-07-20
Pay. Date : 2025-06-23
DMF Number : 40568
Submission : 2024-09-30
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38769
Submission : 2025-03-28
Status :
Type : II
14
PharmaCompass offers a list of Dabigatran Etexilate Mesylate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dabigatran Etexilate Mesylate manufacturer or Dabigatran Etexilate Mesylate supplier for your needs.
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A Dabigatran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dabigatran, including repackagers and relabelers. The FDA regulates Dabigatran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dabigatran 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 Dabigatran supplier is an individual or a company that provides Dabigatran active pharmaceutical ingredient (API) or Dabigatran finished formulations upon request. The Dabigatran suppliers may include Dabigatran API manufacturers, exporters, distributors and traders.
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A Dabigatran DMF (Drug Master File) is a document detailing the whole manufacturing process of Dabigatran active pharmaceutical ingredient (API) in detail. Different forms of Dabigatran DMFs exist exist since differing nations have different regulations, such as Dabigatran USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dabigatran DMF submitted to regulatory agencies in the US is known as a USDMF. Dabigatran USDMF includes data on Dabigatran's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dabigatran USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dabigatran suppliers with USDMF on PharmaCompass.
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