- Cortico- Steroids APIs
- Steroid Hormone APIs
- Fermentation & Biotransformation
- Chemical Synthesis
- Environment
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.
Environment
Our Commitment to a better planet
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.
Biomedical Waste Records
| Year | Name | Download |
|---|---|---|
| 2021 | BMW - Annual Return (Year 2021) SEZ
|  |
SUSTAINABILITY POLICIES AND REPORT
| Year | Site Name | File Name | Download |
|---|---|---|---|
| 2024-2027 | Rau/SEZ | Sustainability Policy |  |
| 2024-2027 | Rau/SEZ | Environment Health & Safety(EHS) Policy | |
| 2024-2027 | Rau/SEZ | Anti-bribery & Anti-Corruption Policy | |
| 2024-2027 | Rau/SEZ | Child Labour and Human Right Policy | |
| 2024-2027 | Rau/SEZ | Code of Conduct | |
| 2024-2027 | Rau/SEZ | Grievance Handling Policy | |
| 2024-2027 | Rau/SEZ | Vigil Mechanism and Whistle Blower Policy | |
| 2024-2027 | Rau/SEZ | IT System Security Policy | |
| 2024-2027 | Rau/SEZ | Sexual Harassment Policy | |
| 2024-2027 | Rau/SEZ | Quality Policy | |
| 2024-2027 | Rau/SEZ | Sustainable Procurement Policy | |
| 2024-2027 | Rau/SEZ | Sullpier's Code of Conduct | |
| 2024-2027 | Rau/SEZ | Product End of Life Cycle | |
| 2024-2027 | Rau/SEZ | ESG Report | |
