Advancing Carbapenem Manufacturing for Global Healthcare

FDA
EU GMP
TGA
MHRA
Health Canada
ANVISA

About Brooks

BSL operates a state-of-the-art, cGMP-compliant manufacturing facility in Vadodara, Gujarat, specializing in Carbapenem APIs and finished-dose injectables.

As one of India’s largest manufacturing facilities dedicated to Carbapenem injections, our vertically integrated capabilities enable greater control across the value chain—from API to finished formulation—supporting consistent quality, reliable supply, and faster access to global markets.

A state of the art R&D facility for API & Injectable formulation development, providing an integrated ecosystem from molecule conceptualization to scale-up readiness, backed by an advanced analytical lab.

Our facility is approved by leading regulatory authorities across the US, Europe, UK, Canada, Brazil, South Africa, Colombia, and other international markets, with 75+ marketing authorizations globally. With deep expertise in Carbapenem anti-infectives and a portfolio of soon to be, vertically integrated formulations. BSL is built to deliver quality, scale, and regulatory confidence to partners worldwide.

Scientist at Brooks Steriscience laboratory

Our Journey

Brooks Steriscience — 2002

The Beginning

BSL Limited is founded by first-generation entrepreneurs Mr. Atul Ranchal and Mr. Rajesh Mahajan, built on the conviction that world-class pharmaceutical manufacturing and affordable access are not competing goals. The company started with a focused formulations mandate that later defined its specialisation in sterile injectable manufacturing.

Brooks Steriscience — 2006

Manufacturing Expansion

A significant step forward came in 2006 with the establishment of the Baddi manufacturing facility receiving WHO-GMP approval strengthened BLL manufacturing foundation and demonstrated its focus on maintaining globally recognized standards of pharmaceutical quality.

Brooks Steriscience — 2012-15

Investment in Infrastructure

To enter the market of niche products BSL acquired 66066 Square Meter Land for installing a state of Art dedicated carbapenem facility for Regulated Markets in State of Gujarat near Vadodara City with clean environment.

Brooks Steriscience — 2017

Commercial Beginnings

BLL commenced its commercial production at its Vadodara site in state of Gujarat India in March 2017 for niche products. Receiving EU-GMP approval further strengthened the foundation of Qualitative products with its commitment of providing safe and quality products to the patients.

Brooks Steriscience — 2018

Quality Milestone

Quality remained at the heart of BSL progress, with WHO-GMP certification achieved in 2018. The milestone reinforced its manufacturing standards and strengthened the company’s capabilities to meet evolving requirements across domestic and international pharmaceutical markets.

Brooks Steriscience — 2019

Entering New Markets

The year 2019 marked broader international recognition, as BLL secured accreditations in Ivory Coast, Cambodia, and Nigeria through NAFDAC. These achievements opened opportunities across new markets while reinforcing the company’s commitment to regulatory and quality requirements.

Brooks Steriscience — 2021

Entering Joint Venture

Brooks achieved another milestone by partnering with Steriscience Specialities Private Limited in March 2021 to further strengthen the Quality know-how and reach the regulated markets like United States and European Markets. The facility was renamed as Brooks Steriscience Limited from April 2021

Brooks Steriscience — 2022

Extending the Reach

In 2021, BSL marked a significant milestone with the creation of its manufacturing capabilities, followed by USFDA, ANVISA Brazil approval and the commencement of supplies to regulated international markets.

Brooks Steriscience — 2024

A Wider Global Footprint

By 2024, BSL had further strengthened its international presence, achieving accreditations in Syria, Vietnam, and the Democratic Republic of Congo. These milestones represent its ongoing journey toward expanding global access to quality pharmaceutical products and building stronger international partnerships.

Brooks Steriscience — 2025

A USFDA First

First company to get USFDA approval for 2g meropenem under generic product.

Brooks Steriscience — 2026

From India to the World

With a newly inaugurated API facility enabling in-house vertical integration, BSL continues to scale capacity — delivering from API to finished dose, from India to the world.

Leadership Team

Ankit Gupta Ankit Gupta Chief Executive Officer
Swamy K N Swamy K N Chief Technical Officer
Swati Kumari Swati Kumari VP, Global Business Development
Sangeetha K Sangeetha K VP & Head , Group Regulatory Affairs
Mr. Santosh Khare Santosh Khare Director, Site
Ashwin John Ashwin John Director, Planning & Projects
Mr. Krishnarao Shirsath Krishnarao Shirsath AVP, Head of Research & Development
Mr. Shivaji Salgaonkar Shivaji Salgaonkar AVP, Head of Site Quality
Mr. Shailendra Sharma Shailendra Sharma AVP, Human Resource

Product Portfolio

Meropenem DPP 500MG, 1G
Meropenem
Imipenem and Cilastatin vials 500MG
Imipenem and Cilastatin
Ertapenem 1g
Ertapenem
Doripenum 500MG
Doripenem
Meropenem DPP 2G
Meropenem
Carbapenem vial production line

India | Carbapenem Manufacturing Site

Operated by BSL, our state-of-the-art facility in Vadodara, Gujarat, is a dedicated Carbapenem manufacturing site with capabilities spanning API to finished dosage forms.

Spread across a 66,000 sqm cGMP-compliant campus, the facility offers dedicated Dry Powder Injection (DDP) and Lyophilized manufacturing lines, providing the flexibility and scale to meet diverse global supply requirements.

With annual capacity of up to ~28 million DDP units and ~1.2 million Lyophilized units, we combine manufacturing scale with specialized Carbapenem expertise.

Our backward-integrated API capabilities strengthen supply chain resilience, enhance operational efficiency, and provide a distinctive advantage in Carbapenem injectable manufacturing.

Approved by leading global regulatory authorities, including US FDA, EU-GMP, MHRA and Health Canada, with additional approvals across LATAM and the Middle East, the site brings regulatory confidence, integrated capabilities, and reliable supply to partners across the US, EU, and global markets. These regulatory approvals apply to our Finished Dose Formulation (FDF) facility, not the API facility.

From API to finished dose. From India to the world.

Our Commitment to Quality

At Brooks, quality is built into every stage of our Carbapenem manufacturing, from raw material qualification to the final release of every vial. Our operations run under strict GMP, with validated processes, rigorous in-process controls, and comprehensive testing, so every batch consistently meets its specifications.

Our manufacturing, quality and regulatory teams work together to keep improving our processes, supported by strong data integrity and full traceability.

Our facility is approved by the US FDA, EU-GMP, MHRA, Health Canada, ANVISA, INVIMA and WHO, reflecting our readiness to serve the world's most regulated markets.

API & Formulation

BSL leverages advanced, closed-system technology for the manufacturing of sterile Active Pharmaceutical Ingredients (APIs), supporting robust contamination control and consistent product quality. Our formulation capabilities include dry powder and lyophilized products manufactured using ALUS filling lines integrated with Restricted Access Barrier Systems (RABS). These advanced technologies enable controlled, high-quality injectable manufacturing while maintaining stringent standards of sterility, safety, and process reliability.

Formulation Block | Quality Control and Engineering

Microbiology lab

The lab comprises dedicated sterility and microbiological testing areas with restricted access and advanced systems to ensure reliable, accurate, and compliant microbiological testing.

Chemical lab

Equipped with advanced analytical instruments for comprehensive on-site physico-chemical testing and stability studies.

Pre-water system

Advanced pre-treatment system by Hydropure, India, with 9,000 L/hr capacity, featuring chlorination, filtration, softening, RO, and hot-water sanitization, compliant with quality standards.

Purified water system

High-capacity, advanced water system utilized for reliable and consistent PW generation, in compliance with USP, Pharm. Eur., and other relevant regulatory standards.

Pure steam generation system

Advanced pure steam generation system with routine sampling and testing, in compliance with USP, Pharm. Eur., and other relevant regulatory standards.

Water for injection

Advanced water system utilized for WFI generation, with routine sampling and testing, in compliance with USP, Pharm. Eur., and other relevant regulatory standards.

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