Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1TAPI Technology & API Services
03 1Cipla
04 1GSK
05 1Hikma Pharmaceuticals
06 1Lupin Ltd
07 1Melody Healthcare
08 1Olon S.p.A
09 1Sterling Chemical Malta
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-12
Pay. Date : 2023-01-09
DMF Number : 36482
Submission : 2023-06-16
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-12
Pay. Date : 2020-09-08
DMF Number : 32945
Submission : 2018-08-12
Status :
Type : II
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A 869113-09-7 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 869113-09-7, including repackagers and relabelers. The FDA regulates 869113-09-7 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 869113-09-7 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 869113-09-7 supplier is an individual or a company that provides 869113-09-7 active pharmaceutical ingredient (API) or 869113-09-7 finished formulations upon request. The 869113-09-7 suppliers may include 869113-09-7 API manufacturers, exporters, distributors and traders.
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A 869113-09-7 DMF (Drug Master File) is a document detailing the whole manufacturing process of 869113-09-7 active pharmaceutical ingredient (API) in detail. Different forms of 869113-09-7 DMFs exist exist since differing nations have different regulations, such as 869113-09-7 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 869113-09-7 DMF submitted to regulatory agencies in the US is known as a USDMF. 869113-09-7 USDMF includes data on 869113-09-7's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 869113-09-7 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 9 companies offering 869113-09-7
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