UnitII(Dehradun)-USFDA APPROVED PLANT

About UnitII(Dehradun)-USFDA APPROVED PLANT

The site is located in fully developed industrial area, Pharmacity, at Dehradun, (Uttarakhand).

The north and south sides of the site are bordered by non-polluting neighboring industries, east and west sides by road.

The site is 25 Km in distance from Dehradun City, 50 Km in distance from Jolly Grant Air Port, 23 Km in distance from Dehradun Railway Station and 02 Km in distance from Dehradun - Chakrata National Highway 72.

Basically lush Green, Pharma friendly environment for the company were considered while selecting the site for the plant.

All USFDA inspections were successfully approved and no more than three to five 483s(minor) were received in any PAI/GMP US FDA inspection.

Pre-formulation and formulation development facility is located at Valsad, Gujarat (near Mumbai)- to conduct development studies for Sidmak projects.

WHO and Schedule M (Indian FDA) compliant 100,000 sq. ft. manufacturing facility for solid oral dosage forms is located at Valsad. This facility has been serving the domestic customers only, including the major Indian Pharma Companies.

Personnel trained on CFR regulations in all 6 system.

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Capacity

Details of the Regulatory Inspections

List of GMP inspections of the site within the last five years:

S. NO. AUDIT DATE INSPECTING AUTHORITY / REGULATORY AUTHORITY PURPOSE OF INSPECTION APPROVAL STATUS
1 27.07.2017 to 28.07.2017 WHO- GMP(CDSCO) Revalidation of COPP Approved
2 27.03.2017 to 31.03.2017 USFDA Routine GMP Audit Approved
3 13.10.2014 WHO- GMP(CDSCO) Revalidation of COPP Approved
4 12.12.2014 WHO- GMP(CDSCO) Compliance Verification Approved
5 02.06.2014 to 06.06.2014 USFDA Routine GMP Audit Approved
6 22.10.2012 to 26.10.2012 USFDA GMP Audit (PAI) Approved