DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2Dr. Reddy's Laboratories
02 1Sichuan Elixir Pharmaceuticals
03 1Granules India Limited
04 2TAPI Technology & API Services
05 1Cipla
06 1F.I.S. Fabbrica Italiana Sintetici
07 1Hetero Drugs
08 1Hikma Pharmaceuticals
09 3MSN Laboratories
10 1Natco Pharma
11 1Shilpa Medicare
12 1Sichuan Xieli Pharmaceutical
13 1Sun Pharmaceutical Industries Limited
14 1Suzhou Lixin Pharmaceutical
15 1Teva Pharmaceutical Industries
16 2Zhejiang Jiuzhou Pharmaceutical
17 1Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-16
Pay. Date : 2016-02-04
DMF Number : 30088
Submission : 2015-12-31
Status :
Type : II
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39648
Submission : 2024-03-27
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37531
Submission : 2022-09-30
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 : 2014-08-13
Pay. Date : 2014-03-19
DMF Number : 28102
Submission : 2014-07-15
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-15
Pay. Date : 2022-08-22
DMF Number : 37161
Submission : 2022-07-08
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 : 2020-08-28
Pay. Date : 2020-05-13
DMF Number : 34874
Submission : 2020-07-14
Status :
Type : II
A Nilotinib Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nilotinib Hydrochloride, including repackagers and relabelers. The FDA regulates Nilotinib Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nilotinib Hydrochloride 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 Nilotinib Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nilotinib Hydrochloride supplier is an individual or a company that provides Nilotinib Hydrochloride active pharmaceutical ingredient (API) or Nilotinib Hydrochloride finished formulations upon request. The Nilotinib Hydrochloride suppliers may include Nilotinib Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Nilotinib Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nilotinib Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Nilotinib Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Nilotinib Hydrochloride DMFs exist exist since differing nations have different regulations, such as Nilotinib Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nilotinib Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Nilotinib Hydrochloride USDMF includes data on Nilotinib Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nilotinib Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nilotinib Hydrochloride suppliers with USDMF on PharmaCompass.
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