Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
01 1Cohance Lifesciences
02 1ALP Pharm
03 2Astellas Pharma
04 1Aurobindo Pharma Limited
05 1CHEMO IBERICA SA
06 1Cipla
07 1Divis Laboratories
08 1GENTHON BV
09 1Gedeon Richter
10 1Hovione
11 1Jiangsu Hengrui Medicine
12 1Lek Pharmaceuticals
13 2Macleods Pharmaceuticals Limited
14 1Maprimed
15 1Medichem S.A
16 1Natco Pharma
17 1SYNTHON Chemicals GmbH & Co. KG
18 1ScinoPharm Taiwan Ltd
19 2Sun Pharmaceutical Industries Limited
20 1Suven Life Sciences Limited
21 1Swati Spentose
22 1Tai Heng Industry Co., Ltd
23 1Unichem Laboratories Limited
24 1Vasudha Pharma Chem
25 1Wockhardt
26 1ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD.
27 1Zambon Switzerland
28 1Zentiva
29 1Zydus Lifesciences
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-23
Pay. Date : 2015-08-27
DMF Number : 28648
Submission : 2014-09-15
Status :
Type : II
32
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A 106138-88-9 (Parent) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 106138-88-9 (Parent), including repackagers and relabelers. The FDA regulates 106138-88-9 (Parent) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 106138-88-9 (Parent) 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 106138-88-9 (Parent) supplier is an individual or a company that provides 106138-88-9 (Parent) active pharmaceutical ingredient (API) or 106138-88-9 (Parent) finished formulations upon request. The 106138-88-9 (Parent) suppliers may include 106138-88-9 (Parent) API manufacturers, exporters, distributors and traders.
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A 106138-88-9 (Parent) DMF (Drug Master File) is a document detailing the whole manufacturing process of 106138-88-9 (Parent) active pharmaceutical ingredient (API) in detail. Different forms of 106138-88-9 (Parent) DMFs exist exist since differing nations have different regulations, such as 106138-88-9 (Parent) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 106138-88-9 (Parent) DMF submitted to regulatory agencies in the US is known as a USDMF. 106138-88-9 (Parent) USDMF includes data on 106138-88-9 (Parent)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 106138-88-9 (Parent) USDMF is kept confidential to protect the manufacturer’s intellectual property.
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