Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1Evonik
02 2Medichem S.A
03 1AVA
04 1Alcon Inc
05 1AstraZeneca
06 1Basic Pharma
07 1Basic Pharma Life Science
08 1Cadila Pharmaceuticals
09 1Cyalume Specialty Products
10 1Delta Synthetic Co. Ltd
11 1Dishman Carbogen Amcis
12 1ECOLAB INC
13 1Glide Chem
14 1HUNAN LIJIE BIOCHEMICAL CO LTD
15 1LAB EXPRESS INTERNATIONAL INC
16 1Lonza Inc & Lonza America Inc
17 1Pfizer Inc
18 1Pliva Hrvatska
19 1R N Laboratories
20 1ROHIT PLASTICS AND CHEMICALS
21 1Reckitt Benckiser
22 1Smaart Pharmaceutticals
23 1Thatcher Group
24 1VIPOR CHEMICALS PRIVATE LTD
25 2Xttrium Laboratories
26 1Blank
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8379
Submission : 1990-01-19
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2012-12-06
DMF Number : 9701
Submission : 1992-05-27
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-10-04
DMF Number : 25149
Submission : 2011-07-25
Status :
Type : II
A Hibitane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hibitane, including repackagers and relabelers. The FDA regulates Hibitane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hibitane 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 Hibitane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hibitane supplier is an individual or a company that provides Hibitane active pharmaceutical ingredient (API) or Hibitane finished formulations upon request. The Hibitane suppliers may include Hibitane API manufacturers, exporters, distributors and traders.
click here to find a list of Hibitane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hibitane DMF (Drug Master File) is a document detailing the whole manufacturing process of Hibitane active pharmaceutical ingredient (API) in detail. Different forms of Hibitane DMFs exist exist since differing nations have different regulations, such as Hibitane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hibitane DMF submitted to regulatory agencies in the US is known as a USDMF. Hibitane USDMF includes data on Hibitane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hibitane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hibitane suppliers with USDMF on PharmaCompass.
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