Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
01 2Granules India Limited
02 2IOL Chemicals and Pharmaceuticals
03 1Aarti Drugs
04 1Auro Laboratories
05 1Aurobindo Pharma Limited
06 1Bausch Health
07 1Exemed Pharmaceuticals
08 2Farmhispania
09 1Hainan Poly Pharm
10 1Harman Finochem
11 1Indoco Remedies Limited
12 1Ions Pharma
13 2Ipca Laboratories
14 1KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO LTD
15 2Karo Pharma
16 1Kothari Phytochemicals & Industries
17 1Laurus Labs
18 1Lupin Ltd
19 1MSN Laboratories
20 1Macleods Pharmaceuticals Limited
21 1Marksans Pharma
22 4Merck Sante SAS
23 1Ningxia Heng Kang Pharmaceutical
24 1Ningxia Hengkang Technology
25 1Olon S.p.A
26 1SHANGHAI MEDICINAL LTD
27 2Shandong Keyuan Pharmaceutical
28 1Shouguang Fukang Pharmaceutical Co., Ltd
29 1Smruthi Organics
30 1Sohan Healthcare
31 2Sun Pharmaceutical Industries Limited
32 1Tianjin Pacific Chemical & Pharmaceutical Co., Ltd
33 1UQUIFA
34 4USV Private Limited
35 5Wanbury Limited
36 1Wockhardt
37 5Blank
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-28
Pay. Date : 2016-07-01
DMF Number : 16625
Submission : 2003-06-06
Status :
Type : II
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27139
Submission : 2013-05-06
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 : 17723
Submission : 2004-09-22
Status :
Type : II
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-21
Pay. Date : 2020-10-29
DMF Number : 35265
Submission : 2020-10-03
Status :
Type : II
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A Dianben manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dianben, including repackagers and relabelers. The FDA regulates Dianben manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dianben 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 Dianben supplier is an individual or a company that provides Dianben active pharmaceutical ingredient (API) or Dianben finished formulations upon request. The Dianben suppliers may include Dianben API manufacturers, exporters, distributors and traders.
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A Dianben DMF (Drug Master File) is a document detailing the whole manufacturing process of Dianben active pharmaceutical ingredient (API) in detail. Different forms of Dianben DMFs exist exist since differing nations have different regulations, such as Dianben USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dianben DMF submitted to regulatory agencies in the US is known as a USDMF. Dianben USDMF includes data on Dianben's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dianben USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dianben suppliers with USDMF on PharmaCompass.
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