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MANUFACTURING

Manufacturing Facilities

Rakshit has 4 cGMP compliance manufacturing facilities located in Hyderabad and Vishakhapatnam, India.

Each of our manufacturing facilities is designed, equipped and operated to deliver high quality products within defined cost and delivery schedules. We have capabilities in wide range of APIs / intermediates and have handled varied process reactions and reactor volumes up to 14KL.

Our commitment to quality and productivity is reflected in the implementation of total quality management processes at every stage of the manufacturing life cycle which is acknowledged by our ever expanding list of clientele globally.

Production Capabilities

  • Total reactors volume of ~779 KL (Reactor capacity ranging from 100 liter to 14 KL).
  • Clean rooms of 11 modules available for manufacture of APIs, compliant to c GMP standards.
  • Perform operations with wide temperature ranges of -70° C to +160° C.

Rakshit Drugs Pvt Ltd (unit I,II )

  • Established in 2000 at Khazipally, Hyderabad.
  • USFDA Approval 2018
  • WHO – GMP approved
  • Japan PMDA approved
  • A total of 3 production blocks with a combined operating volume of 190 KL.
  • Reactor capacity ranging from 1 KL to 12 KL
  • No of reactors - 64
  • Complemented with 2 modules Clean Room Facilities

Rakshit Drugs Pvt Ltd (unit III )

  • Established in 2019 at JN Pharmacity, Parwada, Visakhapatnam.
  • A total of 2 production blocks with a combined operating volume of 320 KL.
  • Complemented with 4 modules Clean Room Facilities
  • Reactor capacity ranging from 3 KL to 14 KL.
  • No of reactors - 40

Rakshit Pharmaceuticals Ltd

  • Established in 2008 at JN Pharmacity, Parwada, Visakhapatnam.
  • Korean FDA Approval
  • WHO - GMP approved
  • EU – Written confirmation
  • Mexico - Coffepris
  • CEPs approved for Sildenafil Citrate, Pantoprazole Sodium , Tadalafil CEPs and for many products are under progress
  • A total of 4 production blocks with a combined operating volume of 275 KL.
  • Complemented with 6 modules Clean Room Facilities
  • Reactor capacity ranging from 100 liters to 12 KL.
  • No of reactors - 80
  • Pilot plant used for scale up and low volume operations.
  • Located in Pharma City with common effluent handling facility.
  • In-house process development lab works on technology absorption, yield improvement and cost reduction.

Production Capabilities

  • Total reactors volume of ~779 KL (Reactor capacity ranging from 100 liter to 14 KL).
  • Clean rooms of 11 modules available for manufacture of APIs, compliant to c GMP standards.
  • Perform operations with wide temperature ranges of -70° C to +160° C.

Rakshit Drugs Pvt Ltd (unit I,II )

  • Established in 2000 at Khazipally, Hyderabad.
  • USFDA Approval 2018
  • WHO – GMP approved
  • Japan PMDA approved
  • A total of 3 production blocks with a combined operating volume of 190 KL.
  • Reactor capacity ranging from 1 KL to 12 KL
  • No of reactors - 64
  • Complemented with 2 modules Clean Room Facilities

Rakshit Drugs Pvt Ltd (unit III )

  • Established in 2019 at JN Pharmacity, Parwada, Visakhapatnam.
  • A total of 2 production blocks with a combined operating volume of 320 KL.
  • Complemented with 4 modules Clean Room Facilities
  • Reactor capacity ranging from 3 KL to 14 KL.
  • No of reactors - 40

Rakshit Pharmaceuticals Ltd

  • Established in 2008 at JN Pharmacity, Parwada, Visakhapatnam.
  • Korean FDA Approval
  • WHO - GMP approved
  • EU – Written confirmation
  • Mexico - Coffepris
  • CEPs approved for Sildenafil Citrate, Pantoprazole Sodium , Tadalafil CEPs and for many products are under progress
  • A total of 4 production blocks with a combined operating volume of 275 KL.
  • Complemented with 6 modules Clean Room Facilities
  • Reactor capacity ranging from 100 liters to 12 KL.
  • No of reactors - 80
  • Pilot plant used for scale up and low volume operations.
  • Located in Pharma City with common effluent handling facility.
  • In-house process development lab works on technology absorption, yield improvement and cost reduction.

Achievements

Since its establishment, Rakshit has achieved several milestones as the manufacturer of bulk actives, pharma chemicals and ingredients for pharmaceutical applications. Some of the achievements are:

  • WHO GMP certification
  • EU written confirmation
  • Our facility has been approved by USFDA
  • Our facility has been approved by KFDA ( Korea)
  • Our facility has been accredited by Japan PMDA for Intermediate.
  • Our facility has been accredited by Mexico Coffepris

COS/CEP Status:

  • Sildenafil Citrate - COS/ CEP granted (Ro-CEP 2014- 36-Rev 00)
  • Pantoprazole Sodium Sesquihydrate - COS/CEP granted (Ro-CEP 2014-060-Rev 00)
  • Tadalafi l - COS/CEP Field ( CEP 2016-317 ) granted (Ro-CEP 2016-317-Rev 00)
  • Famotidine – CEP filed in December 2019.
  • Many products under filing.