Manufacturing Facilities

API Manufacturing Facilities

Our manufacturing facility is FDA-approved, WHO GMP, cGMP certified and ISO 9001: 2015 certified. Our R&D facility is capable of developing non-infringing APIs.
Cerata Pharmaceuticals LLP currently operates API manufacturing sites in Gujarat and Himachal Pradesh in India. Another manufacturing site is proposed to be set up near Ahmedabad, India in 2025.
Our Three manufacturing plants receive innovations from our two R&D centres. These cutting-edge manufacturing facilities have received accreditation from a number of agencies, including the FDA, GMP and WHO-GMP.
Manufacturing units of Cerata Pharmaceuticals LLP have undergone comprehensive audits in the areas of Environmental, Health, and Safety (EHS), Quality, and Sustainability by several leading Big Pharma companies. Impressively, 5 out of the top 30 Big Pharma companies across Asia, Africa, and America have chosen to partner with Cerata for their API needs..
As a core generic API manufacturer, Cerata is well-equipped to handle highly hazardous and energetic reactions, including the management of NBL, Cyanide, and metals. We have dedicated facilities for high-pressure reactions, capable of handling pressures up to 20 Kg/cm², as well as Cyanations and pyrophoric reactions.
We take safety seriously, with segregated and dedicated production blocks for handling High Energetic Reactions, Azide Chemistry, and Pressure Reactions. Our containment facility includes closed handling systems such as Glove boxes for charging, Isolators for offloading, Powder Transfer Systems, and flexible isolators for tasks like changing filters and cleaning utensils. Cerata's commitment to safety, quality, and innovation underscores our dedication to excellence in the pharmaceutical industry.
The pilot plants at Cerata Pharma are capable of handling highly potent products and several low-dose products under cGMP.
Cerata Pharmaceuticals LLP operates as a commercial-scale manufacturer of both non-potent and highly potent Active Pharmaceutical Ingredients (APIs).
We have the capacity to deliver API quantities ranging from grams to thousands of tons, all produced under stringent cGMP (current Good Manufacturing Practices) standards.
Cerata's pharmaceutical areas adhere to stringent cleanliness standards, meeting Class 100,000 clean air requirements. Each pharmaceutical suite is equipped with appropriate filtration and drying equipment, including centrifuges, ANFD, VTDR (Vacuum Tray Dryers), RCVD (Rotary Cone Vacuum Dryers), as well as milling and sieving equipment. This comprehensive setup ensures the highest quality and compliance with pharmaceutical manufacturing standards.

At Cerata Pharmaceuticals LLP, our cutting-edge manufacturing facilities stand as a testament to our commitment to excellence. These state-of-the-art facilities are outfitted with the latest technology and uphold the most stringent quality standards in the industry.

KILO LABS :

Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, inventore veritatis et quasi architecto beatae.

Cerata Pharmaceuticals operates a Kilo Lab facility that adheres to cGMP (current Good Manufacturing Practices) standards.
This Kilo Lab is versatile and multipurpose, designed for conducting scale-up studies and facilitating the production of kilograms (Kgs) to hundreds or even thousands of kilograms (00s of Kgs) of materials.
It serves as a crucial component in our pharmaceutical manufacturing capabilities, enabling us to ensure product quality and efficiency during scale-up processes.

Pilot Plant :

Cerata Pharmaceuticals' pilot plants are integral to our commitment to safe and efficient pharmaceutical production.

1. Physical Segregation and Containment: Our plants are designed to prevent cross-contamination and ensure safety.
2. Hazardous Reaction Handling: We have robust containment systems for managing risky reactions safely.
3. Advanced Capabilities: All pilot plants are equipped with state-of-the-art technology, including cryogenic, high-temperature, and high-vacuum capabilities. These features enable us to handle a wide range of reactions and processes efficiently.
4. Isolation Equipment: We offer a wide range of isolation equipment for quality control and safety. These facilities play a crucial role in our commitment to producing high-quality pharmaceutical products while prioritizing safety and environmental responsibility.

COMMERCIAL SCALE :

Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, inventore veritatis et quasi architecto beatae.

Multipurpose Facilities: Our production facilities are versatile, ensuring flexibility in manufacturing.
Special Production Blocks: We have specialized blocks for handling pyrophoric reactions, high-energy processes, Azide chemistry, and high-pressure operations, all with stringent safety protocols in place.
Large Batch Sizes: Our capabilities extend to batch sizes as substantial as 6 metric tons, accommodating diverse production needs effectively and efficiently