DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Aarti Pharmalabs
03 1TAPI Technology & API Services
04 1Acebright India Pharma Private Limited
05 1Apotex Pharmachem
06 1Archimica
07 1Cipla
08 1Divis Laboratories
09 1Hetero Drugs
10 2Intas Pharmaceuticals
11 1JIANGSU ZW PHARMACEUTICALS CO LTD
12 1Jiangsu Hengrui Medicine
13 1LIANYUNGANG GUIKE PHARMACEUTICAL
14 1MSN Laboratories
15 1Mac-Chem Products (India) Pvt.Ltd
16 2Qilu Tianhe Pharmaceutical Co., Ltd.
17 1Reliance Life Sciences Private Limited
18 1ScinoPharm Taiwan, Ltd
19 1Shilpa Medicare
20 1Sichuan Xieli Pharmaceutical
21 1Signa S.A. de C.V.
22 1Sun Pharmaceutical Industries Limited
23 1Vannsh Life Sciences
24 1Viatris
25 1Zhejiang Cheng Yi Pharmaceutical Co., Ltd
26 1Zhejiang Hisun Pharmaceutical
27 1Zydus Lifesciences
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 : 22479
Submission : 2009-01-30
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 : 22954
Submission : 2009-07-17
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 : 2016-01-21
Pay. Date : 2015-11-12
DMF Number : 29209
Submission : 2015-11-19
Status :
Type : II
A Capecitabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Capecitabine, including repackagers and relabelers. The FDA regulates Capecitabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Capecitabine 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 Capecitabine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Capecitabine supplier is an individual or a company that provides Capecitabine active pharmaceutical ingredient (API) or Capecitabine finished formulations upon request. The Capecitabine suppliers may include Capecitabine API manufacturers, exporters, distributors and traders.
click here to find a list of Capecitabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Capecitabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Capecitabine active pharmaceutical ingredient (API) in detail. Different forms of Capecitabine DMFs exist exist since differing nations have different regulations, such as Capecitabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Capecitabine DMF submitted to regulatory agencies in the US is known as a USDMF. Capecitabine USDMF includes data on Capecitabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Capecitabine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Capecitabine suppliers with USDMF on PharmaCompass.
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