Manufacturing
Business Operations
Manufacturing
UNIT-1- KADECHUR, YADGIR DISTRICT, KARNATAKA
Unit I is situated at Kadechur- KIADB- IDA in Yadgir District, Karnataka which is approximately 171 Kilometers from Hyderabad airport. It is developed on a total area of 25 acres and has three production blocks including the Kilo Labs and other supporting departments such as quality assurance and quality control (QA & QC) and regulatory affairs.
In keeping with its commitment to provide assured quality, the Unit I manufacturing facility adheres to stringent guidelines and requirements of good manufacturing practices (GMP) and are approvable by international health and regulatory agencies.
Our committed team with 100% involvement with detailed production planning and execution will enable Suraj Laboratories to deliver the products manufactured meeting global compliant standards with on time delivery.
Manufacturing
Manufacturing Facilities
- Plant Capability: cGMP multiproduct facility with reactor volume: ~300 KL, and capacity to handle 10’s of kilos to 100’s of tons with Dedicated Production Blocks & dedicated lines.
- Quality System: Suraj Laboratories ensures the product is manufactured and tested inline to the defined quality system and plant capabilities will be in line to the Global expectations and cover the product-specific requirements. We strictly follow the principle of QBD (Quality by Design) and ensure the best quality products are manufactured, tested and shipped to the customers.
| capabilities | manufacturing plant |
|---|---|
|
Synthesis |
3 Production Blocks & 2 Clean Rooms with >100 KL in Volume. Range of GLR, SSR & Hydrogenators from 10L to 5000L Reactors with Kilo Scale All Glass infrastructure. |
|
Analytical |
QC- 21 CFR Compliant-6 HPLC, 4 GC. Equipped with testing infrastructure, 6 Stability Chambers and Microbiology Lab |
|
Utilities |
-20 Deg. C till 300 Deg. C Pressure: up to 14 Kg/cm2 Standard utilities available |
|
Ware House |
Dedicated Solid, Liquid, Gas and Hazardous Material Ware house. PESO Solvent storage yard. |
|
Compliance |
CGMP approved facility and CGMP Manufacturing License available and ISO 9001:2015; EMS 14,001 and HSMS 45001 (OHSAS) Certified. Facility is compliant to US FDA, EDQM and other Global regulatory standards. |
|
EHS |
660 KL Fire Hydrant capacity; Fire Detection and Mitigation Capacity |
|
Area Extent |
25 Acres – Currently used 7 Acres |
|
Employees Size in No’s |
110 |
Our Business
Generics - cGMP Scale Manufacturing
Our focus is on meticulous, well-documented manufacturing, minimizing errors, and ensuring every batch meets the highest standards for quality, purity, and potency. We achieve this by adhering to strict cGMP (Current Good Manufacturing Practice) regulations. These regulations encompass all aspects of production, from pristine and well-maintained facilities to calibrated and validated equipment. Our personnel are rigorously trained in cGMP practices, guaranteeing consistent excellence.
Scalability is key – we can handle small batches for initial trials or seamlessly transition to large-scale commercial production, all while maintaining the same rigorous cGMP controls. Regardless of volume, you can be confident in the quality and consistency of your product.
We share your responsibility
Hydrogenators:
| Parameters | Hydrogenator Reactor Capacity | |
|---|---|---|
| 3 KL | 5 KL | |
| Design Temperature | 20 – 250°C | 20 – 250°C |
| Working Temperature | 20 – 200°C | 20 – 200°C |
| Working Pressure – Shell | 15 Kg/cm2 | 15 Kg/cm2 |
| Working Pressure – Jacket | 3.3 Kg/cm2 | 3.3 Kg/cm2 |
| Hydro Test Pressure | 21.5 Kg/cm2 | 21.5 Kg/cm2 |