MANUFACTURING
A Century of Pharmaceutical Legacy. Modern Sterile Manufacturing.
Combining over 100 years of pharmaceutical and clinical legacy with state-of-the-art sterile manufacturing capabilities, T. Walker’s Pharmaceuticals Pvt. Ltd. specializes in the manufacturing and marketing of high-quality injectable pharmaceutical products.
Our manufacturing philosophy is built on three enduring principles: quality, precision and continuous innovation. From our heritage of pharmaceutical manufacturing to our modern WHO-GMP-certified facility in Pune, we continue to evolve our capabilities while remaining committed to the standards that have defined T. Walker’s for generations
Infrastructure
T. Walker’s Today
WHO-GMP Certified Facility
Located at Kasaramboli, Pune, Maharashtra, our advanced manufacturing facility operates under stringent standards for quality, safety, purity and process control.
The facility is situated approximately 2.5 km from Pirangut on a site of approximately 37,000 sq. ft., in a clean, non-polluted and dust-free environment.
Our manufacturing unit is WHO-GMP certified and designed to support the controlled production of sterile pharmaceutical formulations, particularly Small Volume Parenterals (SVPs).
Specialized Expertise
Our core manufacturing expertise lies in high-integrity sterile liquid injectables and critical-care pharmaceutical solutions.
The facility is equipped with modern infrastructure and machinery to manufacture sensitive, potent and sterile liquid injectable products. Depending on product requirements, our capabilities include both terminally sterilized and aseptically filled formulations.
5th Generation Leadership
T. Walker’s represents a pharmaceutical legacy carried forward through five generations of leadership.
Our approach combines the trust and experience built over more than a century with modern scientific practices, technological advancement and continuous innovation.
This balance of heritage and modern thinking enables us to continuously strengthen our manufacturing capabilities and meet the evolving requirements of the pharmaceutical industry.
State-of-the-Art Manufacturing Infrastructure
The success of our manufacturing operations is strongly supported by our modern production processes, infrastructure and quality systems.
Our facility is equipped to support controlled pharmaceutical manufacturing across critical stages of production, including:
- Small Volume Parenteral (SVP) manufacturing
- Sterile liquid injectable manufacturing
- Aseptic filling of selected formulations
- Terminal sterilization of selected products
- In-process quality monitoring and controls
- Analysis of incoming raw materials
- Testing and analysis of finished products
- Controlled manufacturing and handling environments
- Quality-focused documentation and process controls
Every stage of manufacturing is performed with a strong focus on product integrity, consistency, sterility and patient safety.
Quality & Regulatory Compliance
Quality is at the heart of our manufacturing operations.
Our manufacturing facility and processes are established in accordance with applicable pharmaceutical industry standards and regulatory requirements, including:
- WHO-GMP requirements
- Food and Drug Administration (FDA), Maharashtra
- Applicable Pharmacopoeial Specifications
- Maharashtra Pollution Control Board (MPCB)
Our quality systems are designed to ensure that materials, processes and finished products are subject to appropriate controls and evaluation throughout the manufacturing lifecycle.
Sterile Injectable Manufacturing
T. Walker’s has developed specialized expertise in the manufacture of sterile injectable pharmaceutical formulations.
Our manufacturing activities encompass the production of Small Volume Parenterals, with selected products manufactured through terminal sterilization and others through aseptic filling processes.
From raw-material analysis and controlled production to filling, sterilization, quality control and finished-product testing, our operations are structured around maintaining high standards of quality, sterility and consistency.
Manufacturing Capabilities
Small Volume Parenterals
Specialized manufacturing capabilities for sterile liquid pharmaceutical products in the SVP segment.
Sterile Liquid Injectables
Infrastructure and processes designed for the controlled manufacture of sensitive and sterile injectable formulations.
Aseptic Filling
Controlled aseptic filling capabilities for formulations requiring stringent protection against microbial contamination.
Terminal Sterilization
Manufacturing capabilities for products suitable for terminal sterilization, supporting product sterility and quality.
Quality Control & Analysis
Analysis of input materials and finished pharmaceutical products to support consistent quality and compliance.
A Trusted Manufacturing Partner
Alongside our own portfolio of pharmaceutical products, primarily injectables, T. Walker’s has also served reputed pharmaceutical manufacturers by supplying formulations on a Loan Licence basis.
Our combination of manufacturing expertise, quality systems, regulatory understanding and professional management enables us to support pharmaceutical partners seeking a dependable manufacturing platform for injectable formulations.
Licensed Pharmaceutical Manufacturing
Our manufacturing facility operates under Drug Manufacturing Licence No. PD-65 for Small Volume Parenterals (SVP), Form No. 28, issued by the Food and Drug Administration, Maharashtra State, Pune.
The facility is WHO-GMP certified, reflecting our commitment to maintaining appropriate standards in pharmaceutical manufacturing, quality assurance, documentation, process control and regulatory compliance.
Built on Trust. Engineered for Precision.
For more than a century, T. Walker’s has evolved with the pharmaceutical industry while staying true to its fundamental commitment to quality and trust.
Today, our WHO-GMP-certified facility in Pune brings together generations of pharmaceutical experience, modern sterile manufacturing technology and a culture of continuous improvement.
With 5th generation leadership, specialized injectable manufacturing expertise and a strong quality-driven approach, T. Walker’s continues to build on its legacy while preparing for the future of pharmaceutical manufacturing.
100+ Years of Legacy | WHO-GMP Certified | Sterile Injectable Expertise | 5th Generation Leadership
T. Walker’s Pharmaceuticals Pvt. Ltd.
Precision in Manufacturing. Confidence in Quality. A Legacy of Trust.
Quality Assurance & Quality Control
Quality at Every Stage
At T. Walker’s Pharmaceuticals, quality is not limited to testing the finished product—it is built into every stage of the manufacturing process.
Our dedicated Quality Assurance (QA) and Quality Control (QC) teams work together to maintain robust quality systems, ensure compliance with applicable regulatory requirements and support the consistent manufacture of safe, effective and high-quality pharmaceutical products.
Quality Assurance Team
Building Quality into Every Process
Our Quality Assurance team is responsible for establishing, implementing and continuously strengthening the systems that govern our pharmaceutical manufacturing operations.
The team works closely with Manufacturing, Quality Control, Engineering, Warehouse and other functions to ensure that activities are performed in accordance with approved procedures, specifications and applicable GMP requirements.
Key areas of Quality Assurance include:
- Implementation and monitoring of GMP and quality systems
- Review and approval of Standard Operating Procedures (SOPs)
- Batch manufacturing and packaging documentation review
- Monitoring of manufacturing processes and compliance
- Deviation, investigation and CAPA management
- Change control and document control
- Handling and evaluation of product quality complaints
- Support for product recall and traceability systems
- Qualification and validation activities
- Internal quality audits and compliance monitoring
- Training and GMP awareness for personnel
- Vendor and supplier quality assessment
- Review of manufacturing and quality records
- Support for regulatory inspections and audits
Through a proactive quality-management approach, the QA team helps ensure that quality and compliance are considered from the beginning of the manufacturing process through final product release.
Quality Control Team
Science-Driven Testing & Analysis
Our Quality Control team is responsible for the analytical evaluation of raw materials, packaging materials, in-process samples and finished pharmaceutical products.
Supported by appropriate laboratory infrastructure and analytical practices, the QC team performs testing in accordance with approved specifications, validated methods and applicable pharmacopoeial requirements.
Key areas of Quality Control include:
- Sampling and testing of raw materials
- Analysis of packaging materials
- In-process quality testing and monitoring
- Testing of finished pharmaceutical products
- Analytical evaluation against approved specifications
- Support for sterility and microbiological quality requirements
- Analytical method implementation and verification
- Stability studies and stability monitoring
- Maintenance and calibration of laboratory instruments
- Maintenance of analytical records and documentation
- Investigation of out-of-specification and out-of-trend results
- Support for batch release through comprehensive analytical data
The QC team plays a critical role in generating reliable analytical data that supports informed decisions on material and product quality.
QA & QC — Working Together for Quality
Quality Assurance and Quality Control have distinct responsibilities, but work together as an integrated quality function.
Quality Assurance focuses on the systems, processes and compliance framework that prevent quality issues, while Quality Control focuses on the scientific testing, analysis and verification of materials and products.
Together, the teams help maintain a systematic approach to:
Raw Materials → Manufacturing → In-Process Controls → Filling → Sterilization → Finished Product Testing → Quality Review → Product Release
This integrated approach enables T. Walker’s to maintain strong oversight of product quality throughout the manufacturing lifecycle.
A Culture of Continuous Improvement
Our commitment to quality extends beyond compliance. We believe in continuously improving our processes, systems, people and technology.
Through ongoing training, monitoring, investigation, corrective and preventive actions, process improvements and management oversight, our quality teams contribute to building a culture where quality, safety and patient confidence remain central to every decision.
Quality Assurance. Quality Control. Quality by Design.
At T. Walker’s Pharmaceuticals, our quality teams combine scientific expertise, regulatory discipline and a commitment to continuous improvement to support the manufacture of high-quality sterile injectable pharmaceutical products.
This section can also be presented visually on the website as two side-by-side cards — “Quality Assurance” and “Quality Control” — followed by a horizontal manufacturing-quality flow, which would give the Manufacturing page a much more modern pharmaceutical-corporate appearance.
Schedule M GMP Compliance
Manufacturing in Accordance with Indian GMP Requirements
Walker’s Pharmaceuticals Pvt. Ltd. is committed to maintaining pharmaceutical manufacturing practices in accordance with the applicable requirements of Schedule M of the Drugs Rules, 1945.
Schedule M establishes requirements relating to Good Manufacturing Practices (GMP) as well as the premises, plant and equipment used for pharmaceutical manufacturing. The framework emphasizes systematic quality management, documented procedures, appropriate facilities and equipment, trained personnel, process controls and effective quality oversight. (CDSCO)
For T. Walker’s, adherence to Schedule M principles complements our WHO-GMP-certified manufacturing environment and supports our commitment to consistent quality, safety, sterility and regulatory compliance.
Quality Systems Built Around GMP
Our manufacturing and quality systems are structured to support the fundamental principles of GMP across the complete product lifecycle.
Key areas include:
- Pharmaceutical Quality System
- Controlled manufacturing processes
- Documented Standard Operating Procedures (SOPs)
- Qualified and trained personnel
- Controlled premises and manufacturing environments
- Appropriate plant, equipment and utilities
- Equipment qualification and calibration
- Cleaning and sanitation controls
- Process and cleaning validation
- Material management and traceability
- In-process quality controls
- Quality Control laboratory testing
- Batch documentation and review
- Deviation investigation and CAPA
- Change control
- Internal audits and GMP compliance monitoring
- Stability and ongoing quality monitoring
These systems help ensure that pharmaceutical products are consistently manufactured and controlled according to established quality standards.
Schedule M & Sterile Manufacturing
For a sterile injectable manufacturer, control of the manufacturing environment and processes is particularly important.
- Walker’s manufacturing operations for Small Volume Parenterals and sterile liquid injectables are supported by controlled facilities, appropriate equipment, documented procedures and quality oversight.
Our approach focuses on maintaining appropriate controls throughout critical operations such as:
Material Receipt & Testing → Dispensing → Manufacturing → Filtration → Filling → Sterilization / Aseptic Processing → Inspection → Finished Product Testing → Batch Review → Release
The applicable GMP framework is integrated with our quality systems to support the manufacture of products meeting approved specifications and applicable regulatory requirements.
CDSCO has specifically referenced the implementation of revised Schedule M together with relevant WHO Technical Report Series guidance, including guidance relating to sterile pharmaceutical products. (CDSCO)
Facility, Plant & Equipment
Our manufacturing infrastructure is developed with attention to the requirements applicable to pharmaceutical premises, plant and equipment.
This includes appropriate consideration of:
- Manufacturing area design and controlled environments
- Equipment suitability and qualification
- Utilities and supporting systems
- Environmental and contamination controls
- Cleaning and sanitation
- Preventive maintenance
- Calibration and monitoring
- Material and personnel movement
- Documentation and traceability
These controls provide the foundation for reliable and reproducible pharmaceutical manufacturing.
A Stronger Commitment to Compliance
At T. Walker’s, GMP compliance is viewed not simply as a regulatory requirement, but as an essential part of our quality culture.
Our Quality Assurance and Quality Control teams work alongside Manufacturing and other functions to monitor compliance, evaluate risks, investigate deviations and continuously improve our systems.
By combining our 100+ years of pharmaceutical legacy, WHO-GMP-certified facility, Schedule M-aligned GMP systems and specialized sterile injectable manufacturing expertise, we continue to strengthen our capabilities as a trusted pharmaceutical manufacturing partner.
WHO-GMP Certified | Schedule M GMP Compliance | Sterile Injectable Expertise | Quality-Focused Manufacturing
Website wording recommendation: If you have an official Schedule M compliance/approval certificate or inspection report for the Kasaramboli facility, I can make this section substantially stronger by adding a “Regulatory & Certifications” panel with the exact certificate names, licence numbers, issuing authorities and validity dates.
Production Team — Excellence in Sterile Injectable Manufacturing
At T. Walker’s Pharmaceuticals Pvt. Ltd., our Production Team is the driving force behind the consistent manufacture of high-quality sterile injectable medicines. Working within a WHO-GMP-certified manufacturing environment, our experienced professionals combine pharmaceutical expertise, disciplined execution and a strong culture of quality to ensure that every batch is manufactured safely, consistently and in accordance with approved procedures.
For sterile products, GMP places particular emphasis on qualified personnel, controlled manufacturing environments, contamination prevention, validated processes and documented procedures. (World Health Organization)
Precision in Every Stage of Production
Our Production Team oversees the complete manufacturing process—from dispensing and compounding to filtration, filling, sealing, sterilization, inspection and final packing—while maintaining strict adherence to approved Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs) and established GMP requirements.
Our approach is built around quality by design and prevention rather than relying solely on finished-product testing. WHO emphasizes that quality must be built into pharmaceutical manufacturing processes and cannot simply be tested into the finished product. (World Health Organization)
Specialized Expertise in Sterile Manufacturing
Sterile injectable manufacturing demands a high degree of operational discipline. Our Production Team is trained in:
- Aseptic and controlled manufacturing practices
- Cleanroom operations and personnel hygiene
- Contamination and cross-contamination prevention
- Proper gowning and aseptic practices
- Sterile filtration and filling operations
- Equipment operation and cleaning procedures
- In-process controls and process monitoring
- Batch documentation and data integrity
- Deviation reporting and investigation support
- Good Documentation Practices (GDP)
- GMP compliance and continuous improvement
WHO guidance specifically recognizes personnel training in hygiene, microbiology and sterile-product manufacturing as an important component of sterile pharmaceutical operations. (World Health Organization)
A Culture of Quality, Compliance & Accountability
Our Production Team works closely with Quality Assurance, Quality Control, Engineering, Validation and Warehouse functions to maintain an integrated pharmaceutical quality system. Every manufacturing activity is performed with defined responsibilities, documented controls and appropriate checks.
From the preparation of materials to the completion of a finished batch, our team focuses on maintaining process consistency, product integrity, sterility assurance and regulatory compliance.
Trained People. Controlled Processes. Trusted Medicines.
We believe that advanced facilities and sophisticated equipment deliver their true value only when supported by competent and responsible people. Therefore, our Production Team undergoes ongoing training and competency development relevant to their responsibilities and the requirements of sterile pharmaceutical manufacturing.
Our people are committed to one fundamental principle:
Every batch matters. Every process matters. Every patient matters.
Manufacturing with Confidence
With a strong foundation in WHO-GMP principles, experienced personnel and a systematic approach to sterile manufacturing, our Production Team strives to deliver injectable products that meet defined standards of quality, safety, consistency and reliability.
- Walker’s Pharmaceuticals Pvt. Ltd. — Manufacturing with precision. Quality with purpose. Trust built over generations.
Note: If your facility is specifically WHO-GMP certified, the wording “WHO-GMP-certified manufacturing environment” is appropriate. If you also hold Schedule M approval, that can be highlighted separately as a regulatory credential rather than calling Schedule M itself a certification. WHO describes GMP as a quality-assurance system covering production, quality control, personnel, premises, materials and documented processes. (World Health Organization)