IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
01 1IOL Chemicals and Pharmaceuticals
02 2Granules India Limited
03 1ACIC Europe API & Pharmaceuticals
04 1ACS DOBFAR SPA
05 2Adare Pharma Solutions
06 2Albemarle Corporation
07 1Arch Pharmalabs
08 2BASF
09 4Catalent Pharma Solutions
10 1Cipla
11 1F. Hoffmann-La Roche
12 1Forest Laboratories
13 2Hubei Biocause Heilen Pharmaceutical Co., Ltd
14 1IPC Process Center GmbH & Co
15 2Industriale Chimica
16 1JUHUA GROUP CORP PHARMACEUTICAL FACTORY
17 1Luna Chemicals
18 4Mallinckrodt Pharmaceuticals
19 1NAGASE Europa GmbH
20 1Particle Dynamics International, LLC.
21 1Pfizer Inc
22 1Piramal Enterprises Limited
23 2SI Group
24 2SMS Pharmaceuticals
25 2Shandong Xinhua Pharmaceutical
26 4Solara Active Pharma Sciences
27 3Wanbury Limited
28 1Yonezawa Hamari Chemicals\
29 1Zambon Switzerland
30 1Zibo Xinhua Perrigo Pharmaceutical
31 13Blank
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-13
Pay. Date : 2014-06-09
DMF Number : 22431
Submission : 2009-01-15
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 : 20606
Submission : 2007-06-12
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 : 35886
Submission : 2021-05-18
Status :
Type : II
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A Gofen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gofen, including repackagers and relabelers. The FDA regulates Gofen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gofen API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Gofen supplier is an individual or a company that provides Gofen active pharmaceutical ingredient (API) or Gofen finished formulations upon request. The Gofen suppliers may include Gofen API manufacturers, exporters, distributors and traders.
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A Gofen DMF (Drug Master File) is a document detailing the whole manufacturing process of Gofen active pharmaceutical ingredient (API) in detail. Different forms of Gofen DMFs exist exist since differing nations have different regulations, such as Gofen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gofen DMF submitted to regulatory agencies in the US is known as a USDMF. Gofen USDMF includes data on Gofen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gofen USDMF is kept confidential to protect the manufacturer’s intellectual property.
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