APIs :OUR CORE COMPETENCE
At GreenRock, our state-of-the-art facilities boast a versatile range of equipment, spanning from kilo-scale to several-ton capacity. With single batch sizes exceeding 500 Kgs, we're equipped to meet the demands of various APIs. Our dedicated R&D and fully-equipped Quality Control Laboratory ensure the highest standards of excellence.
STERILE
Location
Zhuhai,China
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
Location
Zhuhai,China
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 DV-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.
Fine Chemicals
Location
Zhuhai,China
Regulatory Approval
US FDA & EU GMP (German-Bavaria)
Annual Production Capacity
8000 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 GreenRock to enhance our supply chain security and reduce our dependence on outsourced Fine Chemicals.
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.
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Research & Development Lab
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Inoculum Lab
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Fermentation Block
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Downstream Block
Location
Fuxin,China
Regulatory Approval
US FDA & EU GMP(German-Bavaria)
Annual ProductionCapacity
225000 litre (225M³).
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
GreenRock's exceptional capability in Fine Chemicals manufacturing sets us apart. Our expertise in chemical synthesis plays a pivotal role in transforming Fine Chemicals derived from Biotransformation into essential base compounds for products like Hydrocortisone, Dexamethasone, Betamethasone, Prednisolone, and Methylprednisolone. This intricate process encompasses multiple stages with complex chemistry and a diverse range of operating conditions, including cryogenic temperatures.
Location
Zhuhai,China
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
At GreenRock, we consistently reaffirm our dedication to harmonize with nature, striving to make our planet a better place for everyone today and tomorrow. Our SHE (Safety, Health & Environmental) Policy underscores our leadership in the research and manufacturing of corticosteroids. We conduct all operations with a steadfast commitment to safeguarding the environment, the health and safety of our employees, partners, and the community.
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.