DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Medichem S.A
03 1TAPI Technology & API Services
04 1Actavis Inc
05 1Aurobindo Pharma Limited
06 1Cipla
07 1Dishman Carbogen Amcis
08 1Enaltec Labs Private Limited
09 1Hetero Drugs
10 1Ind Swift Laboratories Limited
11 1Innovare Labs
12 1Jubilant Generics
13 1Lupin Ltd
14 1MSN Laboratories
15 1Macleods Pharmaceuticals Limited
16 1Megafine Pharma (P) Limited
17 1Piramal Pharma Solutions
18 1Solara Active Pharma Sciences
19 1Sun Pharmaceutical Industries Limited
20 1UQUIFA
21 1Unichem Laboratories Limited
22 1Viwit Pharmaceuticals Limited
23 1Yueyang Xinhua Pharmaceutical
24 1Yung Shin Pharm Industrial
25 1Zydus Lifesciences
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-07-03
DMF Number : 27211
Submission : 2013-06-28
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-25
Pay. Date : 2014-03-14
DMF Number : 21405
Submission : 2008-03-06
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 : 21264
Submission : 2008-01-23
Status :
Type : II
A Cinacalcet manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cinacalcet, including repackagers and relabelers. The FDA regulates Cinacalcet manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cinacalcet 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 Cinacalcet manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cinacalcet supplier is an individual or a company that provides Cinacalcet active pharmaceutical ingredient (API) or Cinacalcet finished formulations upon request. The Cinacalcet suppliers may include Cinacalcet API manufacturers, exporters, distributors and traders.
click here to find a list of Cinacalcet suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cinacalcet DMF (Drug Master File) is a document detailing the whole manufacturing process of Cinacalcet active pharmaceutical ingredient (API) in detail. Different forms of Cinacalcet DMFs exist exist since differing nations have different regulations, such as Cinacalcet USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cinacalcet DMF submitted to regulatory agencies in the US is known as a USDMF. Cinacalcet USDMF includes data on Cinacalcet's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cinacalcet USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cinacalcet suppliers with USDMF on PharmaCompass.
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