OVERVIEW

Our two large-scale manufacturing facilities in Indore, Central India, are built conforming to cGMP regulations and compete with the best in the world in terms of infrastructure and technological capabilities. Our equipment ranges from a kilo scale to several ton capacity with a single batch size exceeding 500 kg for several APIs with dedicated R&D and well-equipped Quality Control Laboratory.

As the Steroid Chemistry experts in India, we offer a complete backward integration to the basic Soy Sterol molecule using process technologies, like cutting-edge fermentation technology and fine Synthetic Chemistry.

Our manufacturing capabilities include the wide range of Steroid-Hormone Base APIs and derivatives like Hydrocortisones, Prednisolones, Dexamethasones, Betamethasones, Methylprednisolones, Progestin, Estrogens, Testosterones and other Steroidal-Sex-Hormone Derivatives. Our facilities provide a perfect blend of aesthetic and technological excellence.

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

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Sterile-image

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.
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Sterile-image

UNIT-2

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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.
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Steroid-Hormone-image
Steroid-Hormone-image

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

    Research & Development Lab

  • inoculumlab

    Inoculum Lab

  • fermentationlab

    Fermentation Block

  • downstreamblock

    Downstream Block

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Sterile-image

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.

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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.

Environment

Our Commitment to a better planet

Symbiotec has pledged a solemn commitment to environmental preservation.

In pursuit of modernization and enhancement of our capacities, Symbiotec has never failed to fulfil its social obligations.

We offer a commitment to remain an environment-friendly company continuously, which is reflected in zero waste disposal of water waste by employing a very effective effluent treatment plant with necessary incineration arrangements.

We have dedicated teams that help ensure our environment does not pay the cost for any of the solutions we provide.

At Symbiotec, with every step, we reaffirm our commitment to grow in tandem with nature, turning this planet into a better place for everyone to live in today and tomorrow.

Our SHE (Safety, Health & Environmental) Policy

Symbiotec shall uphold its position as a leader in the research and manufacturing of corticosteroids by conducting all its operations to protect the environment, health and safety of employees, associated parties and the community.

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Environment-image

In fulfilment of this commitment, we maintain continual efforts to:

  • Comply with all the relevant health, safety, and environmental laws and regulations.
  • Consider the identified environmental aspects, safety and occupational healthhazards for effective control.
  • Enhance safety, Health and Environment awareness among employees through effective communication and training programs.
  • Investigation at workplace accidents, incidents leading to possible pollution to the environment and/or illness to promptly correct / prevent any such conditions and/or practices.
  • Integrate SHE considerations into all facets of business planning and decision making.
  • Campaign SHE (Safety, Health & Environmental i.e. the SHE Policy), responsibility among our employees / associated parties to promote their involvement in adopting good practices for achieving the goals of this policy.