Manufacturing Facility

State-of-the-art infrastructure ensuring quality and compliance.

Cerata Pharmaceuticals LLP operates Three WHO-GMP Certified API manufacturing facilities in Gujarat, India

  • Dedicated API manufacturing plants for hormone, steroid, oncology & peptide APIs
  • FDA-approved, WHO-GMP and cGMP compliant API manufacturer
  • ISO 9001:2015 certified quality management systems
  • Manufacturing supported by two dedicated R&D centers
  • High-volume API manufacturer and global exporter of APIs
  • Supplying both regulated and semi-regulated markets worldwide
Manufacturing Facility
API Manufacturing
  • End-to-end API manufacturing from R&D to commercialization
  • Gram-scale development to multi-ton commercial production
  • Continuous process optimization and seamless technology transfer
  • Strong impurity profiling and batch-to-batch consistency control
  • Reliable long-term supply for generic and specialty pharmaceuticals
  • Infrastructure designed for potent and high-complexity APIs

Our Manufacturing Plants

Three specialized API manufacturing units equipped with state-of-the-art infrastructure and adhering to global regulatory standards.

Steroid & Hormone API Manufacturing Unit

Steroid & Hormone API Manufacturing Unit

Total Production Blocks : 5
Manufacturing Facilities in Gujarat, India
CAPACITY
  • Reactor capacity: 100 L to 50 KL
  • Fermentation capacity: 1KL to 60 KL
  • Designed Capacity: 250 KL
  • Phase 1 capacity: 100 KL – Operational
  • Final API batch size: 1 kg – 500 kg
REGULATORY INSPECTIONS
  • FDA
  • cGMP
  • WHO-GMP
  • Audit-ready documentation
Oncology API Manufacturing Unit

Oncology API Manufacturing Unit

Total Production Blocks : 5
Manufacturing Facilities in Gujarat, India
CAPACITY
  • Reactor capacity: 50 L to 40 KL
  • Final API batch size: 1 kg – 50 kg
  • Dedicated Cytotoxic API Areas
REGULATORY INSPECTIONS
  • FDA
  • cGMP
  • WHO-GMP
  • Audit-ready documentation
Peptide API Manufacturing Unit

Peptide API Manufacturing Unit

Total Production Blocks : 4
Manufacturing Facilities in Gujarat, India
CAPACITY
  • Reactor capacity: 50 L – 5 KL
  • Reaction temperature range: -20°C to 200°C
  • Final API batch size: 1 g – 25 kg
  • Production scale: Pilot to commercial
REGULATORY INSPECTIONS
  • FDA
  • cGMP
  • WHO-GMP
  • Audit-ready documentation

Specialized Manufacturing Infrastructure

All manufacturing facilities of Cerata Pharmaceuticals LLP are organized into specialized areas to ensure precision, safety, and regulatory compliance.

Dedicated Manufacturing Areas

Multiple cleanrooms with controlled environments for different product categories

Quality Assurance

Comprehensive QA systems ensuring compliance at every stage

Hazardous Reaction Blocks

Specialized areas for high-energy and sensitive reactions

High Containment Systems

Advanced safety systems for potent and hazardous compounds

Process Development & R&D Labs

State-of-the-art laboratories for innovation and process optimization

In-house Microbiological Laboratory

Complete microbial testing and environmental monitoring

Warehouse & Material Stores

Organized storage with proper segregation and inventory control

Engineering & Maintenance

24/7 technical support and preventive maintenance

Pilot Plant / Scale-Up Area

Seamless transition from laboratory to commercial production

Analytical & Stability Chambers

ICH-compliant stability studies and analytical method development

Regulatory Compliance

All facilities designed and maintained to meet global regulatory standards

Powder Handling Systems

Glove boxes, isolators, and containment systems for safe handling

Quality Control

Instrumental, Chemical & Microbiology testing facilities

Cold Storage

Temperature-controlled storage for sensitive materials

Waste Management

Environmental compliance and sustainable waste disposal

Continuous Improvement

Ongoing infrastructure upgrades and technology adoption

15+
Specialized Areas
100%
Regulatory Compliance
24/7
Operations
ISO
Certified Systems

World-Class Manufacturing Equipment & GMP Infrastructure

At Cerata Pharmaceuticals LLP, our advanced GMP-compliant infrastructure enables safe, precise, and scalable manufacturing of Steroid, Hormone, Oncology, and Peptide APIs for global pharmaceutical markets.

Reactors & Assemblies

Filtration & Separation

Size Reduction & Particle Control

Drying & Evaporation Systems

GMP Compliance

Fully GMP-Compliant Infrastructure

All equipment and systems designed and maintained to meet FDA, WHO-GMP, and international regulatory standards for pharmaceutical manufacturing.

FDA Compliant
WHO-GMP Certified
ISO Standards
Regular Audits
Data Integrity
Quality Systems

Powder Handling & Containment

Utility Systems & Support

Automation & Control Systems

Environmental & Safety Systems

Comprehensive Manufacturing Capabilities

Cerata Pharmaceuticals LLP combines world-class infrastructure with unparalleled expertise to deliver complex APIs to the global pharmaceutical industry.

Manufacturing Excellence

Three World-Class Facilities

Cerata Pharmaceuticals LLP operates three large-scale, world-class API manufacturing facilities in Gujarat, India, dedicated to the development and commercial production of Hormone, Steroid, Oncology, and Peptide Active Pharmaceutical Ingredients (APIs).

End-to-End Manufacturing

The company’s infrastructure supports end-to-end API manufacturing, from gram-scale R&D and pilot batches to multi-ton commercial production, under stringent cGMP conditions across all stages.

High-Volume Global Exporter

Cerata is globally recognized as a high-volume, quality-driven API manufacturer and exporter, supplying regulated and semi-regulated markets with consistent, compliant, and scalable API solutions.

Manufacturing Infrastructure

Advanced cGMP Pilot Plants

Cerata operates advanced cGMP pilot plants capable of handling highly potent compounds with occupational exposure limits (OELs) as low as 10 mcg/m³, along with multiple low-dose and niche APIs.

Class 100,000 Cleanrooms

Pharmaceutical manufacturing areas comply with Class 100,000 cleanroom standards and are equipped with robust production and finishing infrastructure, including centrifuges, ANFDs, VTDRs, RCVDs, milling, sieving, and controlled drying systems.

R&D Supported Manufacturing

Three manufacturing facilities are supported by two dedicated R&D centers, enabling continuous process development, impurity control, yield optimization, cost efficiency, and seamless technology transfer to commercial scale.

Chemical Expertise

Complex Chemistry Mastery

As a core generic API manufacturer, Cerata has extensive expertise in complex and hazardous chemistries, including cyanide chemistry, NBL reactions, metal-based reactions, azide chemistry, pyrophoric reactions, and high-pressure reactions up to 20 kg/cm².

Segregated Production Blocks

Dedicated and segregated production blocks are designed for high-energetic reactions, pressure reactions, and potent API handling, ensuring maximum safety, containment, and operational control.

Advanced Containment Systems

Containment infrastructure includes closed material-handling systems, such as glove boxes, isolators, powder transfer systems, and flexible isolators for cleaning, filter changes, and critical operations.

Quality & Safety

Global Regulatory Compliance

All manufacturing sites are FDA-approved, WHO-GMP and cGMP compliant, and ISO 9001:2015 certified, ensuring alignment with international regulatory and quality standards.

Strong EHS Culture

Cerata maintains a strong Environmental, Health & Safety (EHS) culture, with manufacturing units undergoing comprehensive audits covering EHS, Quality, and Sustainability by global pharmaceutical companies.

Commercial-Scale Manufacturing

Cerata operates as a commercial-scale manufacturer of both non-potent and highly potent APIs, with proven capability to manage complex product lifecycles from development through long-term supply.

Global Operations

Export-Oriented Manufacturer

As an export-oriented API manufacturer, Cerata serves pharmaceutical companies across Asia, Africa, Europe, the Americas, and other international markets, supporting diverse regulatory requirements.

Scalable Global Supply

With the ability to supply APIs in quantities ranging from grams to thousands of tons, Cerata ensures secure, scalable, and uninterrupted global supply.

Big Pharma Partnerships

The company has successfully partnered with 5 of the top 30 Big Pharma companies across Asia, Africa, and the Americas, reflecting strong regulatory credibility, manufacturing reliability, and long-term trust.

Quality Assurance

Batch-to-Batch Consistency

Strong process control, validated systems, and disciplined quality practices ensure batch-to-batch consistency, regulatory confidence, and dependable performance.

Long-Term Partnership Focus

Cerata’s integrated approach—combining technical expertise, advanced infrastructure, regulatory compliance, and safety-driven operations—positions the company as a long-term manufacturing partner, not merely a supplier.

Continuous Investment

Continuous investments in capacity expansion, technology upgrades, and quality systems reinforce Cerata Pharmaceuticals LLP’s commitment to delivering high-quality Hormone, Steroid, Oncology, and Peptide APIs to the global pharmaceutical industry.

3
World-Class
Manufacturing Facilities
5
Top 30 Big Pharma
Partnerships
2
Dedicated
R&D Centers
100%
Regulatory
Compliance

Business Enquiries

Interested in our manufacturing capabilities? Get in touch with our team.