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01 1Fermion Oy
02 1ALP Pharm
03 1Arch Pharmalabs
04 1Benzo Chem Industries Pvt
05 1Charioteer
06 1Cipla
07 1Emcure Pharmaceuticals
08 1Fresenius Kabi AB Brunna
09 1Hetero Drugs
10 1Hubei Haosun Pharmaceutical Co., Ltd.
11 1JARI Pharmaceutical
12 1Jiangsu Hengrui Medicine
13 1Laurus Labs
14 1Mac-Chem Products (India) Pvt.Ltd
15 1Olon S.p.A
16 1Pliva Hrvatska
17 2Polymed Therapeutics Inc.
18 1Qilu Pharmaceutical
19 1Sai Phytoceuticals
20 2ScinoPharm Taiwan, Ltd
21 1Shilpa Medicare
22 1Sichuan Xieli Pharmaceutical
23 3Sun Pharmaceutical Industries Limited
24 1Terumo
25 1YAKULT HONSHA CO LTD
26 1Zhejiang Hisun Pharmaceutical
27 1Zydus Lifesciences
01 1CPT-11
02 1IHL- 305 IRINOTECAN LIPOSOME INJECTION
03 1IRINOTECAN HCL
04 5IRINOTECAN HYDROCHLORIDE
05 1IRINOTECAN HYDROCHLORIDE (NON STERILE, API)
06 8IRINOTECAN HYDROCHLORIDE TRIHYDRATE
07 1IRINOTECAN HYDROCHLORIDE TRIHYDRATE (NON-STERILE BULK) DRUG SUBSTANCE
08 5IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP
09 1IRINOTECAN HYDROCHLORIDE TRIHYDRATE, USP (FORM B)
10 4IRINOTECAN HYDROCHLORIDE USP
11 1IRINOTECAN HYDROCHLORIDE USP (NON-STERILE BULK) DRUG SUBSTANCE
12 1IRINOTICAN HYDROCHLORIDE
13 1SN38
01 8China
02 1Croatia
03 1Finland
04 13India
05 1Italy
06 2Japan
07 1Sweden
08 2Taiwan
09 2U.S.A
01 17Active
02 14Inactive
01 8Complete
02 23Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-14
Pay. Date : 2013-09-05
DMF Number : 20649
Submission : 2007-06-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23220
Submission : 2009-10-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-28
Pay. Date : 2015-09-22
DMF Number : 23522
Submission : 2010-01-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20739
Submission : 2007-08-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-02
Pay. Date : 2018-10-31
DMF Number : 22296
Submission : 2008-11-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21500
Submission : 2008-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-09
DMF Number : 19050
Submission : 2005-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21183
Submission : 2007-12-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17312
Submission : 2004-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-21
Pay. Date : 2018-11-16
DMF Number : 21713
Submission : 2008-06-10
Status : Active
Type : II
A Irinotecan Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Irinotecan Hydrochloride, including repackagers and relabelers. The FDA regulates Irinotecan Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Irinotecan 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 Irinotecan Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Irinotecan Hydrochloride supplier is an individual or a company that provides Irinotecan Hydrochloride active pharmaceutical ingredient (API) or Irinotecan Hydrochloride finished formulations upon request. The Irinotecan Hydrochloride suppliers may include Irinotecan Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Irinotecan Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Irinotecan Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Irinotecan Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Irinotecan Hydrochloride DMFs exist exist since differing nations have different regulations, such as Irinotecan Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Irinotecan Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Irinotecan Hydrochloride USDMF includes data on Irinotecan Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Irinotecan Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Irinotecan Hydrochloride suppliers with USDMF on PharmaCompass.
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