Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Seqens
03 1Dr. Reddy's Laboratories
04 1Cipla
05 1Hubei Haosun Pharmaceutical Co., Ltd.
06 1Syn-Tech Chem. & Pharm
07 1Zhejiang Hisun Pharmaceutical
01 2GRANISETRON
02 3GRANISETRON BASE
03 2GRANISETRON USP
01 2China
02 1France
03 2India
04 1Spain
05 1Taiwan
01 6Active
02 1Inactive
01 1Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21790
Submission : 2008-06-24
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22311
Submission : 2008-12-15
Status : Active
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 : 23128
Submission : 2009-09-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18820
Submission : 2005-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22089
Submission : 2008-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-29
Pay. Date : 2015-03-20
DMF Number : 25980
Submission : 2012-04-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16470
Submission : 2003-03-10
Status : Inactive
Type : II
A Granisetron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Granisetron, including repackagers and relabelers. The FDA regulates Granisetron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Granisetron 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 Granisetron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Granisetron supplier is an individual or a company that provides Granisetron active pharmaceutical ingredient (API) or Granisetron finished formulations upon request. The Granisetron suppliers may include Granisetron API manufacturers, exporters, distributors and traders.
click here to find a list of Granisetron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Granisetron DMF (Drug Master File) is a document detailing the whole manufacturing process of Granisetron active pharmaceutical ingredient (API) in detail. Different forms of Granisetron DMFs exist exist since differing nations have different regulations, such as Granisetron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Granisetron DMF submitted to regulatory agencies in the US is known as a USDMF. Granisetron USDMF includes data on Granisetron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Granisetron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Granisetron suppliers with USDMF on PharmaCompass.
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