Manufacturing of Steroid & Hormone APIs
Cerata Pharmaceuticals LLP operates a WHO-GMP compliant manufacturing facility dedicated to the production of high-quality Steroid and Hormone Active Pharmaceutical Ingredients (APIs). Our integrated approach combines technical expertise, advanced infrastructure, and stringent quality systems, making us a trusted partner for pharmaceutical companies worldwide.
Dedicated Manufacturing Blocks
Our specialized facility is organized into dedicated blocks for optimized production workflows
Fermentation & Bioconversion
Microbial/enzymatic steroid transformation with controlled fermentation processes and bioconversion expertise.
- Backward integration from Soy Sterol
- Controlled fermentation processes
- Advanced bioconversion technology
Chemical Synthesis
Multi-step reactions for steroid & hormone intermediates with tight control of stereochemistry and impurity profiles.
- Multi-step synthetic chemistry
- Stereochemistry control
- Impurity profile management
Crystallization & Drying
Nutsch filters, agitated dryers, vacuum tray & rotocone dryers for precise crystallization and drying processes.
- Nutsch filter systems
- Agitated dryers
- Vacuum tray & rotocone dryers
Powder Handling & Milling
Micronizing, sieving, blending, and granulation for optimal particle size distribution and product consistency.
- Micronizing equipment
- Precision sieving
- Blending & granulation
Utility & Support
Water purification, HVAC, brine/chiller, steam boiler, compressed air, and effluent treatment systems.
- Water purification systems
- HVAC & environmental control
- Effluent treatment plant
Manufacturing Capacity & Scale
From process development to commercial production
Scalable Production Infrastructure
Our facility is equipped with kilo-scale to multi-ton capacity reactors, covering the complete lifecycle from process development and pilot batches to large-scale commercial production.
Fermentation-Based Steroid & Hormone Manufacturing
Advanced biotechnology meets pharmaceutical chemistry
Integrated Biotechnology & Chemistry
Our manufacturing processes are supported by extensive in-house steroid and hormone chemistry expertise and full backward integration, ensuring consistent quality from raw material to final API.
- Backward Integration: Complete control from Soy Sterol raw material
- Process Control: Controlled fermentation and bioconversion processes
- Chemistry Expertise: Advanced multi-step synthetic chemistry
- Quality Assurance: Tight control of stereochemistry and impurity profiles
- Consistency: High-purity output with batch-to-batch consistency
Quality Systems & Compliance
Meeting global pharmaceutical standards
R&D & Quality Control
The facility includes a dedicated R&D unit for process optimization, technology transfer, and scale-up, along with a fully equipped Quality Control laboratory for in-process, intermediate, and final API testing, using validated analytical methods.
Certifications & Compliance
- WHO-GMP Certified API Manufacturing facility
- ISO 9001:2015 compliant operations
- Robust Quality Management System
- Batch-to-batch consistency and full traceability
- Audit-ready documentation for global inspections
- Environmental responsibility and regulatory compliance
Product Categories
Specialized manufacturing across key therapeutic categories
Corticosteroids
15+ APIsAnti-inflammatory and immunosuppressant agents for treating conditions like asthma, arthritis, and skin disorders.
Key Applications:
- Asthma & Respiratory Disorders
- Rheumatoid Arthritis
- Dermatological Conditions
- Autoimmune Diseases
Sample Products:
Anabolic Steroids
12+ APIsAndrogenic agents that promote muscle growth and tissue repair, used in medical treatments for muscle wasting and hormonal imbalances.
Key Applications:
- Muscle Wasting Diseases
- Hormone Replacement Therapy
- Osteoporosis Treatment
- Anemia Management
Sample Products:
Hormones
20+ APIsEndocrine system regulators including estrogen, progesterone, and testosterone derivatives for various therapeutic applications.
Key Applications:
- Contraceptive Formulations
- Hormone Replacement Therapy
- Fertility Treatments
- Menopausal Symptoms
Sample Products:
Partner with Cerata for Your Steroid & Hormone API Needs
With our integrated approach combining technical expertise, advanced infrastructure, and stringent quality systems, Cerata Pharmaceuticals LLP is positioned as a trusted partner for pharmaceutical companies worldwide seeking Steroid and Hormone APIs.