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Uk Mhra Gmp
•STRIDES SHASUN LIMITED•January 9, 2017

STRIDES SHASUN LIMITED – UK MHRA GMP Certificate UK API 20003 Insp GMP 20003/16179217-0001 [H]

Record Details

This Uk Mhra Gmp record concerns STRIDES SHASUN LIMITED, with an inspection on January 9, 2017, issued by the MHRA, covering drugs.

Company
STRIDES SHASUN LIMITED
Compliance status
GMPC
Certificate type
GMP
Inspection date
January 9, 2017
Issued
April 28, 2017
MIA number
UK API 20003
Site address
RS NO. 33 AND 34, MATHUR ROAD, PERIYAKALAPET, PUDUCHERRY, IN 605014, INDIA
Country
INDIA
Products
Human Medicinal Products
Manufacturing operations
[2000011939] IBUPROFEN SODIUM [3000011909] S-(+)-IBUPROFEN [2000011938] IBUPROFEN LYSINE [1000008918] IBUPROFEN [2000017096] IBUPROFEN 90% DIRECT COMPRESSION Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES IBUPROFEN SODIUM 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1  Manufacture Of Active Substance Intermediates 3.1.2  Manufacture Of Crude Active Substance 3.1.3  Salt Formation/Purification steps (eg. Crystallisation) Salt formation, Purification, Crystallisation and Isolation 3.5 General Finishing Steps 3.5.1  Physical Processing Steps Drying, Milling, Blending & Sieving 3.5.2  Primary Packaging 3.5.3  Secondary Packaging 3.6 Quality Control Testing 3.6.1  Physical / Chemical testing S-(+)-IBUPROFEN 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1  Manufacture Of Active Substance Intermediates 3.1.2  Manufacture Of Crude Active Substance 3.1.3  Salt Formation/Purification steps (eg. Crystallisation) Salt formation, Purification, Crystallisation and Isolation 3.5 General Finishing Steps 3.5.1  Physical Processing Steps Drying, Milling, Blending & Sieving 3.5.2  Primary Packaging 3.5.3  Secondary Packaging 3.6 Quality Control Testing 3.6.1  Physical / Chemical testing IBUPROFEN LYSINE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1  Manufacture Of Active Substance Intermediates 3.1.2  Manufacture Of Crude Active Substance 3.1.3  Salt Formation/Purification steps (eg. Crystallisation) Salt formation, Purification, Crystallisation and Isolation 3.5 General Finishing Steps 3.5.1  Physical Processing Steps Drying, Milling, Blending & Sieving 3.5.2  Primary Packaging 3.5.3  Secondary Packaging 3.6 Quality Control Testing 3.6.1  Physical / Chemical testing IBUPROFEN 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1  Manufacture Of Active Substance Intermediates 3.1.2  Manufacture Of Crude Active Substance 3.1.3  Salt Formation/Purification steps (eg. Crystallisation) Oxidation, Purification, Crystallisation & Isolation 3.5 General Finishing Steps 3.5.1  Physical Processing Steps Drying, Milling, Blending & Sieving 3.5.2  Primary Packaging 3.5.3  Secondary Packaging 3.6 Quality Control Testing 3.6.1  Physical / Chemical testing IBUPROFEN 90% DIRECT COMPRESSION 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1  Manufacture Of Active Substance Intermediates 3.1.2  Manufacture Of Crude Active Substance 3.1.3  Salt Formation/Purification steps (eg. Crystallisation) Oxidation, Purification, Crystallisation & Isolation 3.5 General Finishing Steps 3.5.1  Physical Processing Steps Drying, Milling, Blending & Sieving 3.5.2  Primary Packaging 3.5.3  Secondary Packaging 3.6 Quality Control Testing 3.6.1  Physical / Chemical testing
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ID · aea9c27c-f2ac-49aa-8688-f8f180a3ea4c

Other documents for STRIDES SHASUN LIMITED
  • 483 - 2026-05-20May 20, 2026
  • 483 - 2022-12-05December 5, 2022
  • 483 - 2019-05-24May 24, 2019
  • WARNING_LETTER - 2019-02-05February 5, 2019
  • 483 - 2017-05-26May 26, 2017

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