WORLD CLASS QUALITY.
SYNTHIMED CAPABILITIES
WORLD CLASS QUALITY IN
DESIGN, EQUIPMENT, OPERATION
DELIVERS PRODUCTS OF
WORLD-QUALITY STANDARDS
LARGEST CUMULATIVE
REACTOR CAPACITIES
AUDITED BY REGULATORY AUTHORITIES
USFDA, KFDA, PMDA, ANVISA, EDQM
22
MANUFACTURING BLOCKS
MANUFACTURING
Synthimed Labs’ Advanced Manufacturing Facilities
Multi-Locational Manufacturing Sites
Largest Cumulative Reactor Capacities
- Synthimed Labs possesses one of the largest cumulative reactor capacities in North India, enabling complex reaction capabilities and stringent controls to form the ideal base for innovative and quality products.
Focus on Operational Excellence and Quality Circles
- The capacity build-up is rooted in the company’s focus on operational excellence and quality circles, aiming to continuously improve processes, eliminate inefficiencies, and facilitate lean procedures.
Rigorous Regulatory Inspections and Audits
- The flagship manufacturing site at Derabassi is periodically inspected and audited by regulatory authorities like USFDA, KFDA, PMDA, ANVISA, EDQM, among others, ensuring adherence to global quality standards
World-Class Quality Assurance
- Both manufacturing facilities in North India have been designed to ensure world-class quality in design, equipment, and operations, operating in full compliance with Current Good Manufacturing Practice (cGMP) regulations.
Stringent Compliance with cGMP Regulations
- The API Jammu, India facility fully complies with cGMP requirements, underscoring the company’s commitment to stringent quality standards.
International Regulatory Oversight
- The Derabassi manufacturing facility is regularly inspected by local and international health authorities, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), among others, further validating its commitment to global quality standards.
Synthimed Labs Pvt. Ltd. has multi-locational manufacturing sites for producing APIs. The cGMP manufacturing facility at Punjab with 22 manufacturing blocks comprises of a Pilot Plant, dedicated blocks and multi-purpose blocks designed to comply with stringent USFDA and other regulatory standards of approval.
An API manufacturing facility in the state of Jammu & Kashmir complying with cGMP requirements is adding to the capacities of the organization.
The company possesses one of the largest cumulative reactor capacities in North India. Complex reaction capabilities and stringent controls provide an ideal base for innovative and quality products.
DERABASSI FACILITY
- Twenty two dedicated and multipurpose cGMP manufacturing plants.
- Pilot plant facility.
- Dedicated facility for Oncology Products with world class Isolators.
- Dedicated Oral Solid Dosage facility for largest product Clarithromycin Granules.
- Four Solvent Recovery Plant.
JAMMU FACILITY
- Three Dedicated and multipurpose cGMP manufacturing plants.
MANUFACTURING CAPABILITIES
DERABASSI FACILITY
- Installed Reaction Capacity of 505 KL with 185 Stainless Steel reactors and 50 Glass lined reactors, facility is equipped with cryogenic reactor
- 200 MT production capacity every month for Intermediate and APIs
- 2000 KL solvent distillation capacity every month
- High Pressure hydrogenation facility up to 20 kg/cm2
- GMP pilot plant suitable for advance intermediate, Key starting Material and for API
- Purified water system to meet USP39 Quality
- ZERO discharge facility
JAMMU FACILITY
- Installed Reaction Capacity of 162 KL
- 30 MT API Production capacity every month
REACTION CAPABILITIES
WAREHOUSING
Facility is equipped with the storage capacity of 1200 KL liquid and 350 MT solid with controlled temperature storage.
SUPPLY CHAIN
Our effective supply chain systems ensure ON TIME IN FULL delivery to commitments made with customers spread across the globe. Synthimed Labs operates abiding to the principles of business continuity and has taken suitable measures to mitigate and dependency on incoming supplies.
Quality Assurance Systems
At Synthimed Labs, our commitment to quality is unwavering. We prioritize adherence to stringent QA policies to ensure that our operations consistently uphold the highest standards of quality and compliance, aligning with globally recognized best practices.
Mainstay of Competitiveness
- Emphasis on Quality: Quality serves as the cornerstone of our competitiveness, driving our pursuit of excellence in all aspects of our operations.
Integration of Quality Assurance
- Interface Between R&D and Manufacturing: While Quality Assurance functions independently, it functions as a crucial interface between our Research and Development and manufacturing divisions. It strictly adheres to standardized quality systems, ensuring consistency, effectiveness, and efficiency across all our API manufacturing activities at various locations.
Organizational Engagement for Quality
- Shared Responsibility: Every facet of our organization is dedicated to championing the quality ethos, ensuring the implementation of global cGMP standards at every level and during every process.
Effective Quality Systems & Policies
- Continuous Improvement: Our systems and policies are designed to drive effectiveness through regular quality reviews, audits, and compliance assessments to uphold regulatory standards and customer expectations.
Focus on Improvement and Prevention
- Proactive Approach: We focus on reviewing failures, rejections, market complaints, deviations, non-compliances, product stability, and planning corrective and preventive actions to continually enhance our processes.
Striving for Excellence
- Constant Pursuit of Quality Excellence: Our relentless endeavor is to consistently achieve “QUALITY EXCELLENCE,” reflecting our ongoing commitment to unparalleled quality standards.
ESTABLISH QUALITY STANDARDS
TRAIN PERSONNEL
DEVELOP PROCESSES TO ACHIEVE SET STANDARDS
CLOSE MONITORING
CONSISTENCY AT EVERY STAGE
GLOBAL REGULATORY APPROVALS
Our regulatory process also covers:
- Submission of product registration applications in the form of CTD-Dossiers, marketing applications, ANDA, NDA etc.
- Response to queries or deficiencies from regulatory bodies / customers.
- Inspections and inspection reports.
- Post approval / marketing surveillance by regulatory bodies.
- Submission of annual updates to regulatory bodies.
EHS MANAGEMENT SYSTEM
ENVIRONMENT, HEALTH & SAFETY
As an integral part of our EHS philosophy, we think & work together responsibly so that employees & community at large and the environment including natural resources are protected and maintained leaving minimal environmental footprints. Over the record on EHS excellence, Synthimed Labs has adopted a top down approach and embraced the principles and code of best EHS practices into the EHS management system.
Emergency Planning & Fire Protection System
Synthimed Labs has an Onsite Emergency Plan considering all emergency situations. Synthimed Labs have installed all kinds of fire protection systems to meet any kind of emergency.
Fire Hydrant System:
- Facility is safeguard with sufficient hydrant water storage, and related hydrant points across the plants.
Portable Fire Extinguishers:
- Facility is safeguard with sufficient and all kind of fire extinguishers across the plants.
Fire Alarm System:
- Facility is safeguard with satisfactory instrumentation system to handle emergency at site. Sufficient manual call points and emergency sirens are available at site.
SIX MONTH COMPLIANCE REPORT
SLPL DB SIX MONTH COMPLIANCE REPORT (June 2024)
SLPL SAMBA JAMMU SIX MONTH COMPLIANCE REPORT (June 2024)
SLPL FOCAL POINT SIX MONTH COMPLIANCE REPORT (June 2024)
WASTE MANAGEMENT
Synthimed Labs (Derabassi)
Synthimed Labs Pvt. Ltd., Derabassi is engaged in manufacturing Bulk Drugs (Active Pharmaceutical Ingredients) like Clarithromycin, Azithromycine, Letrozole, Anastrazole, Fexofenadine HCl, Fax-10, Atorvastatin Calcium, Clopidogrel Bisulphate, Acamprosate Calcium, Ropinarole, Pioglitazone Hydrochloride, Clarithromycin Granules etc. with green technology at Village Bhagwanpur, Derabassi, Distt. Mohali – Punjab.
As a socially responsible company, Synthimed Labs – Derabassi is continuing its efforts with commitment to consistently minimize the impact on environment.
We comply with all local & national legislation pertaining to safety, health & environment.
At Synthimed Labs three types of pollutants are being generated (liquid, solid & gaseous). These pollutants are effectively treated to give zero discharge facility.
This facility has the capacity to treat effluent 240 KL low TDS in ETP and 165 KL high TDS with New MEE and 65 KL high TDS with OLD MEE.
Liquid waste is treated in ETP & Multi Effect evaporator
- Incinerable Solid waste at Incinerator and non Incinerable being dispose at CTSDF facility at Nimbua, Punjab
- Gaseous in Air Pollution Control Devices Like Alkali Wet scrubbers.
Synthimed Labs (Jammu)
Synthimed Labs Pvt. Ltd., Jammu is engaged in manufacturing Bulk Drugs (Active Pharmaceutical Ingredients) like, Atorvastatin Calcium, Clopidogrel Hydrogen, Nitazoxanide, etc. with green technology at Industrial Growth Center, Phase-I, Samba, Jammu & Kashmir.
As a socially responsible company, Synthimed Labs – Jammu is continuing its efforts with a commitment to consistently minimize the impact on the environment.
We comply with all local & national legislation pertaining to safety, health & environment.
At Synthimed Labs, Jammu three types of pollutants are being generated (liquid, solid & gaseous). These pollutants are effectively treated and treated water is used for cooling tower and plantation. This facility has the capacity to treat effluent 86KL low TDS in ETP and 48 KL high TDS in MEE.
- Liquid waste is treated in Effluent Treatment Plant & Multi Effect Evaporator.
- Incinerable Solid waste at Incinerator and non Incinerable being stored in Hazardous Waste Room inside the premises.
- Air Pollution Control Devices like Alkali Wet scrubbers are provided for Gaseous emissions and Multi Cyclone Dust Collector are provided for particulate matter.
CHEMISTRY
See below our partial list of