Cortico-Steroid : OUR CORE COMPETENCE

The equipment at Symbiotec facilities ranges from a kilo scale to several ton capacity with a single batch size exceeding 500 Kgs for several APIs supported by dedicated R&D and well-equipped Quality Control Laboratory.

STERILE

Location

Rau, Indore, Central India

Annual Production Capacity

50 Metric Tons

Regulatory Approval

WHO - GMP

Key Equipments

• Aseptic filling
• Pure Steam Generator
• 2 Lyophilizers with 200 Kg. ice condensing capacity
• Steam Sterilizer
• Lyophilizer with CIP-SIP features
• Dry Heat Sterilizer
• Class 100 environment.
• Filtration train with CIP-SIP features
• Water For Injection 'WFI'in hot Loop

NON-STERILE

UNIT-1

Location

Rau, Indore, Central India

Annual Production Capacity

Capacity 12 Metric Tons

Regulatory Approval

US FDA & EU GMP (German-Bavaria)

Key Equipments

• Hastalloy, GLR, and SS reactors in AHU-driven Classified Area and FDV-driven technical manufacturing area.
• Classified Clean Rooms and Forced Draught Ventilation or FDV-driven technical manufacturing area.
• Air Jet Mill for particle size reduction down to <5µ.
• Operation range capability from +130°C to -70°C.

UNIT-2

Location

Special Economic Zone (SEZ), Pithampur, Indore, Central India

Regulatory Approval

US FDA & EU GMP (German-Bavaria)

Annual Production Capacity

100 Metric Tons

Key Equipments

• Hastalloy, GLR, and SS reactors in AHU-driven Classified Area and FDV-driven technical manufacturing area.
• Classified Clean Rooms and Forced Draught Ventilation or FDV-driven technical manufacturing area.
• Air Jet Mill for particle size reduction down to <5µ.
• Operation range capability from +130°C to -70°C.

Steroid Hormone APIs

Symbiotec’s Steroidal Hormone manufacturing facility has the seal of approval from US-FDA. The site is dedicated to synthesizing Progestin, Estrone, Testosterone, its derivatives, and Anabolic Steroids.

Location

Special Economic Zone (SEZ), Pithampur, Indore, Central India

Regulatory Approval

US FDA & EU GMP (German-Bavaria)

Annual Production Capacity

8 Metric Tons

Key Equipments

• GLRs and SS reactors in AHU driven Classified and FDV-driven Technical manufacturing areas.
• Containment Technology using Enclosed Powder Transfer Systems (PTS), Glove Box etc.
• RO-EDI USP/EP-Grade purified water in loop.
• Air Jet Mill for Particle Size Reduction down to 5μm.
• Operation range capability from +130°C to –90°C.

Fermentation & Biotransformation

With a scale-up from 5 litre to 35000 litre Fermentors, our ultra-modern Biotech manufacturing facility has been set up by Symbiotec to enhance our supply chain security and reduce our dependence on outsourced Intermediates.

As one of the select few to have mastered the art of Steroidal Biotransformation, our scientists are constantly working to improve fermentation activity with a dedicated focus on research & development on subjects including Gene Mutations for improved strain development.

OUR BIOTECH DIVISION COMPRISES OF FOUR SECTIONS

• 

  Research & Development Lab

• 

  Inoculum Lab

• 

  Fermentation Block

• 

  Downstream Block

Location

Special Economic Zone (SEZ), Pithampur, Indore, Central India

Regulatory Approval

US FDA & EU GMP (German-Bavaria)

Annual Production Capacity

225000 litre (225 M³).

Key Equipments

• Production Fermentors 8 x35000 litre, 4x5000 litre with connecting seed Fermentors and feed vessels.
• Whole Broth Extractor from Westfalia AG
• Micro-filtration
• Agitated Neutche Filter Dryer (ANFD)
• Lyophilizer with CIP-SIP features
• Distributed Control System (DCS) for process control
• Dedicated Microbiology Inoculum Laboratory with classified area ranging from class 100 to class 100000
• Complete R&D setup with 2×30 litre Fermentors, real-time PCR, Nucleic Acid extractor, HPLCs, UPLCs, Fluorescent and Phase contrast microscope with image analyzer, cryo-centrifuges and Fume hoods.

Chemical Synthesis

Intermediate manufacturing capability of Symbiotec is our distinguishing feature. The Chemical synthesis forms the critical link for conversion of Intermediates obtained from Biotransformation to the base compounds for products such as: Hydrocortisone, Dexamethasone, Betamethasone, Prednisolone and Methylprednisolone. The chemical synthesis involves multiple stages with complex chemistry and wide range of operating conditions including cryogenic temperatures.

Location

Special Economic Zone (SEZ), Pithampur, Indore, Central India

Regulatory Approval

US FDA & EU GMP (German-Bavaria)

Annual Production Capacity

206 M³

Key Equipments

• Stainless steel reactors with capacities ranging from 1500 litre to 16000 litre Hastalloy reactor with capacity ranging 4000 litre to 10,000 litre, Glass Lined Reactors capacity ranging from 2500 litre to 16000 litre.
• ANFDs of total capacity 48 M³.
• Mechanized Powder Handling Systems.
• Particle size reduction equipment, for particle size down to <5µ.
• Classified Clean Rooms and Forced Draught Ventilation technical operations areas.
• Purified water system as per USP/EP in the loop.
• In-process Quality Control Laboratory with modern instruments including HPLCs and GCs. Operation range capability from +130°C to -70°C.
• Tank-Farm for Solvents.