DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 3Biophore India Pharmaceuticals Pvt Ltd
03 1Actavis Inc
04 2Apothecon Pharmaceuticals
05 1Biofer
06 1CSL Vifor
07 1Chongqing Pharmaceutical Research Institute Co Ltd
08 1Cilag AG
09 1Emcure Pharmaceuticals
10 1GLAND PHARMA LIMITED
11 1Glenmark Life Sciences
12 1Global Calcium
13 1Hetero Drugs
14 2Lupin Ltd
15 1Nanjing Lifenergy R&D Co Ltd
16 1Opocrin SpA
17 2SNJ Labs
18 1Shanghai Neutan Pharmaceutical
19 1Solara Active Pharma Sciences
20 1Suven Pharmaceuticals
21 3Symed Labs
22 2Viatris
23 1Yabao Pharmaceutical Group Co. Ltd
01 1DS166 DRUG SUBSTANCE
02 1FERRIC OXYHYDROXIDE
03 1FERRIC OXYHYDROXIDE WITH SUCROSE
04 11IRON SUCROSE
05 1IRON SUCROSE (LIQUID)
06 1IRON SUCROSE (NON-STERILE BULK DRUG SUBSTANCE)
07 1IRON SUCROSE (POWDER)
08 1IRON SUCROSE (PYROGEN FREE)
09 3IRON SUCROSE COMPLEX
10 1IRON SUCROSE COMPLEX SOLUTION
11 1IRON SUCROSE CONCENTRATE LIQUID
12 1IRON SUCROSE DRUG SUBSTANCE
13 1IRON SUCROSE INJECTION
14 1SUCROFERRIC OXYHYDROXIDE
15 4SUCROFERRIC OXYHYDROXIDE
16 1VENOFER® CONCENTRATE USA
01 4China
02 20India
03 1Ireland
04 2Italy
05 2Switzerland
06 2U.S.A
01 29Active
02 2Inactive
01 15Complete
02 16Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-04
Pay. Date : 2016-07-14
DMF Number : 28865
Submission : 2016-07-07
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33643
Submission : 2019-03-30
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-10
Pay. Date : 2023-09-28
DMF Number : 38610
Submission : 2023-07-31
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34957
Submission : 2020-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18261
Submission : 2005-04-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-09
DMF Number : 18390
Submission : 2005-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-17
Pay. Date : 2022-03-14
DMF Number : 19544
Submission : 2006-06-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13245
Submission : 1998-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2014-06-03
DMF Number : 27958
Submission : 2014-05-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-04
Pay. Date : 2014-05-22
DMF Number : 27258
Submission : 2013-07-15
Status : Active
Type : II
A Iron Sucrose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iron Sucrose, including repackagers and relabelers. The FDA regulates Iron Sucrose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iron Sucrose 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 Iron Sucrose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iron Sucrose supplier is an individual or a company that provides Iron Sucrose active pharmaceutical ingredient (API) or Iron Sucrose finished formulations upon request. The Iron Sucrose suppliers may include Iron Sucrose API manufacturers, exporters, distributors and traders.
click here to find a list of Iron Sucrose suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iron Sucrose DMF (Drug Master File) is a document detailing the whole manufacturing process of Iron Sucrose active pharmaceutical ingredient (API) in detail. Different forms of Iron Sucrose DMFs exist exist since differing nations have different regulations, such as Iron Sucrose USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iron Sucrose DMF submitted to regulatory agencies in the US is known as a USDMF. Iron Sucrose USDMF includes data on Iron Sucrose's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iron Sucrose USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iron Sucrose suppliers with USDMF on PharmaCompass.
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