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01 1Fujifilm Diosynth Biotechnologies
02 1Lupin Ltd
03 1SIMS Srl
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01 16-ALPHA-METHYLPREDNISOLONE SODIUM SUCCINATE
02 1METHYLPREDNISOLONE SOD. SUCCINATE (THIS DMF FORMERLY HELD BY S.I.R.S)
03 1METHYLPREDNISOLONE SODIUM SUCCINATE
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01 1India
02 1Italy
03 1United Kingdom
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01 1Active
02 2Inactive
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01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6560
Submission : 1986-08-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30375
Submission : 2016-04-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4659
Submission : 1982-08-24
Status : Inactive
Type : II
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A Methylprednisolone Sodium Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methylprednisolone Sodium Succinate, including repackagers and relabelers. The FDA regulates Methylprednisolone Sodium Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methylprednisolone Sodium Succinate 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 Methylprednisolone Sodium Succinate supplier is an individual or a company that provides Methylprednisolone Sodium Succinate active pharmaceutical ingredient (API) or Methylprednisolone Sodium Succinate finished formulations upon request. The Methylprednisolone Sodium Succinate suppliers may include Methylprednisolone Sodium Succinate API manufacturers, exporters, distributors and traders.
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A Methylprednisolone Sodium Succinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Methylprednisolone Sodium Succinate active pharmaceutical ingredient (API) in detail. Different forms of Methylprednisolone Sodium Succinate DMFs exist exist since differing nations have different regulations, such as Methylprednisolone Sodium Succinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methylprednisolone Sodium Succinate DMF submitted to regulatory agencies in the US is known as a USDMF. Methylprednisolone Sodium Succinate USDMF includes data on Methylprednisolone Sodium Succinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methylprednisolone Sodium Succinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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