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 1Neuland Laboratories
04 1TAPI Technology & API Services
05 1Acebright India Pharma Private Limited
06 1Alembic Pharmaceuticals Limited
07 1Apotex Pharmachem
08 1Aurobindo Pharma Limited
09 1Aurore Life Sciences
10 1Biocon
11 1Changzhou Pharmaceutical Factory
12 1Esteve Quimica
13 2Glenmark Life Sciences
14 1Hetero Drugs
15 2Hikal
16 1Hisun Pharmaceutical Nantong
17 1Intas Pharmaceuticals
18 1Jiangxi Synergy Pharmaceutical
19 1Jubilant Generics
20 1Lee Pharma
21 1Lupin Ltd
22 2MSN Laboratories
23 1Micro Labs Limited
24 1Optimus Pharma
25 1Piramal Pharma Solutions
26 1Sichuan Qingmu Pharmaceutical
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
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 : 40568
Submission : 2024-09-30
Status :
Type : II
41
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A Dabigatran Etexilate Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dabigatran Etexilate Mesylate, including repackagers and relabelers. The FDA regulates Dabigatran Etexilate Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dabigatran Etexilate Mesylate 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 Etexilate Mesylate supplier is an individual or a company that provides Dabigatran Etexilate Mesylate active pharmaceutical ingredient (API) or Dabigatran Etexilate Mesylate finished formulations upon request. The Dabigatran Etexilate Mesylate suppliers may include Dabigatran Etexilate Mesylate API manufacturers, exporters, distributors and traders.
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A Dabigatran Etexilate Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dabigatran Etexilate Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Dabigatran Etexilate Mesylate DMFs exist exist since differing nations have different regulations, such as Dabigatran Etexilate Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dabigatran Etexilate Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Dabigatran Etexilate Mesylate USDMF includes data on Dabigatran Etexilate Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dabigatran Etexilate Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 33 companies offering Dabigatran Etexilate Mesylate
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