Veranova: A CDMO that manages complexity with confidence.
01 2Veranova
02 1Granules India Limited
03 1Alkem Laboratories
04 1Apotex Pharmachem
05 1Cambrex Corporation
06 1Curia
07 1SIGMA TAU
08 1Tris Pharma Inc
09 1Blank
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2012-12-19
DMF Number : 24049
Submission : 2010-08-02
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 : 39696
Submission : 2025-03-31
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-25
Pay. Date : 2022-02-28
DMF Number : 36577
Submission : 2022-02-18
Status :
Type : II
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A Sodium Oxybate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Oxybate, including repackagers and relabelers. The FDA regulates Sodium Oxybate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Oxybate 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 Sodium Oxybate supplier is an individual or a company that provides Sodium Oxybate active pharmaceutical ingredient (API) or Sodium Oxybate finished formulations upon request. The Sodium Oxybate suppliers may include Sodium Oxybate API manufacturers, exporters, distributors and traders.
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A Sodium Oxybate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Oxybate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Oxybate DMFs exist exist since differing nations have different regulations, such as Sodium Oxybate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Oxybate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Oxybate USDMF includes data on Sodium Oxybate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Oxybate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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