Plant Overview

A world-class sterile manufacturing facility.

Akums Drugs & Pharmaceuticals Ltd. — Unit III
Facility Type: Sterile Preparations Manufacturing Facility
Address: Plot No. 2, 3, 4 & 5, Sector-6B, IIE, SIDCUL, Ranipur, Haridwar – 249403, Uttarakhand, India

Akums Plant 3 has been specifically designed to manufacture sterile pharmaceutical products under highly controlled environmental conditions. The facility integrates advanced cleanroom technologies, validated manufacturing systems, automated process controls, and comprehensive quality assurance practices to ensure sterility, product integrity, and regulatory compliance throughout the manufacturing lifecycle.

Every manufacturing operation is executed in accordance with current Good Manufacturing Practices (cGMP), supported by robust quality systems, environmental monitoring programs, and validated aseptic processing techniques that minimize contamination risks while ensuring consistent product quality.

At Akums Plant 3, we combine advanced manufacturing technologies, validated aseptic processes, and decades of pharmaceutical expertise to deliver sterile dosage forms that meet the highest international quality standards.

Located in Haridwar's pharmaceutical manufacturing hub, the facility serves both domestic and international markets with world-class infrastructure, highly trained professionals, and globally accepted quality systems that ensure consistency from development to commercial production.

5

Dedicated Manufacturing Units

ISO

9001, 14001, 45001 & 50001 Certified

11+

Global Regulatory Approvals

cGMP

Compliant Manufacturing

Manufacturing Capabilities

Comprehensive sterile dosage form expertise, unit by unit.

Akums Plant 3 is equipped to manufacture a broad portfolio of sterile pharmaceutical products, giving customers access to multiple manufacturing capabilities under one integrated facility.

Unit I — Sterile Injectables

Dedicated to high-quality sterile injectable formulations across diverse packaging formats, employing validated aseptic filling systems, advanced sterilization technologies, and stringent environmental controls.

Ampoules
Vials
Three-Piece Systems
Large Volume Parenterals (LVP)
Small Volume Parenterals (SVP)
Prefilled Syringes (PFS)

Unit II — Dry Powder Injectables (Cephalosporins)

Dedicated containment systems and segregated manufacturing areas for cephalosporin antibiotics, ensuring complete product segregation and contamination control.

Complete product segregation
Specialized HVAC systems
Validated cleaning procedures
Controlled manufacturing environments

Unit III — Dry Powder Injectables (Penicillin)

Exclusively designed for penicillin-based sterile products with complete segregation from other manufacturing areas.

Controlled personnel movement
Validated cleaning protocols
Specialized air handling systems
International regulatory alignment

Sterile Ophthalmic and Nasal Preparations

Unit IV — Sterile Ophthalmic & Nasal Preparations

Supports production of sterile eye drops and nasal drops, manufactured under aseptic conditions with stringent environmental monitoring.

Eye drops
Nasal drops
Sterility & product stability assurance
Patient-safety focused processing

Unit V — Dry Powder Injection Manufacturing

Additional sterile dry powder injectable manufacturing, providing scalable manufacturing capacity for diverse therapeutic applications.

Scalable manufacturing capacity
Diverse therapeutic applications
Highest quality standards

Water for Injection & Clean Steam

Critical sterile utility systems supporting aseptic production and injectable manufacturing across every unit.

Water for Injection (WFI) systems
Clean Steam generation
Validated utilities

Engineering Excellence

Built for Reliable Sterile Manufacturing

Akums Plant 3 has been developed using modern pharmaceutical engineering principles. The integrated facility design minimizes cross-contamination risks while ensuring operational efficiency, regulatory compliance, and manufacturing consistency.

Advanced Cleanroom Environments

Validated HVAC Systems

Controlled Aseptic Processing Areas

Automated Filling & Sealing Systems

High-Performance Sterilization Equipment

Environmental Monitoring Systems

Water for Injection (WFI) Systems

Clean Steam Generation

Validated Utilities

Controlled Material & Personnel Flow

Electronic Process Monitoring

Comprehensive Quality Control Laboratories

Quality Excellence

Quality built into every batch.

Quality is not limited to final product testing — it is integrated into every stage of manufacturing. From raw material qualification to final product release, every manufacturing activity follows validated Standard Operating Procedures supported by scientific risk management and continuous quality oversight.

Quality by Design (QbD)

Manufacturing processes are developed and continuously optimized to ensure consistent product quality and process robustness.

Sterility Assurance

Validated aseptic processing, environmental monitoring, personnel qualification, and sterilization validation collectively ensure sterility throughout production.

Data Integrity

Electronic systems, validated documentation practices, and audit-ready processes ensure complete traceability across every manufacturing stage.

Continuous Improvement

Manufacturing processes are routinely reviewed to identify opportunities for efficiency enhancement, quality improvement, and operational excellence.

Manufacturing Excellence

Key strengths behind every batch we manufacture.

Sterile pharmaceutical manufacturing requires far more than advanced equipment — it demands precision, process discipline, regulatory rigor, and an unwavering commitment to quality. Our integrated approach combines advanced manufacturing infrastructure, qualified technical expertise, validated processes, and robust quality systems to ensure reliable production across diverse sterile dosage forms.

Purpose-built sterile manufacturing infrastructure

Segregated manufacturing blocks for specialized product categories

Advanced aseptic processing and contamination control

Robust Quality Management Systems (QMS)

Validated manufacturing and sterilization processes

Scalable production capabilities for commercial manufacturing

Compliance with global regulatory expectations

Continuous process improvement through operational excellence

Certifications & Approvals

Globally certified, internationally approved.

Our management systems demonstrate our commitment to quality, environmental responsibility, workplace safety, and sustainable manufacturing practices. These approvals reinforce our capability to manufacture pharmaceutical products for regulated, semi-regulated, and emerging international markets.

ISO 9001:2015

Quality Management System, certified by QMS Certification Services Pvt. Ltd.

ISO 14001:2015

Environmental Management System, certified by QMS Certification Services Pvt. Ltd.

ISO 45001:2018

Occupational Health & Safety Management System, certified by RIR Certification Pvt. Ltd.

ISO 50001:2018

Energy Management System, certified by BSI Certification.

EU GMP

European Union Good Manufacturing Practice approval.

Global Presence

Approved by regulatory authorities across the globe.

Akums Plant 3 holds approvals from multiple international regulatory authorities, reflecting the facility's adherence to globally accepted pharmaceutical manufacturing standards.

ANVISA

Brazil

Food Safety and Drug Administration Uttarakhand

FSDA

Uttarakhand, India

Bulgarian Drug Agency

Bulgaria

Ministry of Health

Cambodia

EFMHACA

Ethiopia

PMPB

Malawi

MoHP

Nepal

NAFDAC

Nigeria

FDA

Philippines

NMPB

Sudan

National Drug Authority

Uganda

Commitment to Patient Safety

Every batch is made with the patient in mind.

Every sterile product manufactured at Akums Plant 3 ultimately reaches patients who rely on consistent quality and uncompromised safety. This responsibility drives every manufacturing decision we make. From infrastructure design and process validation to quality assurance and regulatory compliance, our teams work together to ensure that every batch leaving our facility meets the highest standards of sterility, safety, efficacy, and quality.

Let's Build Better Healthcare Together

Partner with Confidence —
Ready to Scale with Akums Plant 3?

Akums Plant 3 represents the convergence of advanced sterile manufacturing, scientific expertise, global quality systems, and scalable pharmaceutical production. Whether you are developing innovative therapies, expanding commercial manufacturing, or seeking a reliable CDMO partner, our facility offers the infrastructure, technical expertise, and regulatory excellence needed to accelerate your product journey. Connect with Akums to explore world-class sterile manufacturing solutions tailored to your business needs.

Common Questions About Akums Plant 3

Where is Akums Plant 3 located?

Plant 3 is located at Plot No. 2, 3, 4 & 5, Sector-6B, IIE, SIDCUL, Ranipur, Haridwar – 249403, Uttarakhand, India, within Haridwar's pharmaceutical manufacturing hub.

What sterile dosage forms are manufactured at Plant 3?

Plant 3 manufactures ampoules, vials, three-piece systems, LVP, SVP, prefilled syringes, dry powder injectables (including cephalosporins and penicillin), and sterile ophthalmic and nasal preparations.

How is product segregation maintained across units?

Cephalosporin and penicillin manufacturing are handled in fully segregated, dedicated units with specialized HVAC systems, controlled personnel movement, and validated cleaning protocols to prevent cross-contamination.

What quality certifications does Plant 3 hold?

The facility holds ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, and ISO 50001:2018 certifications, along with EU GMP and multiple international regulatory approvals.

Which international markets does Plant 3 serve?

Plant 3 holds approvals from authorities including ANVISA Brazil, the Bulgarian Drug Agency, NAFDAC Nigeria, the Philippines FDA, and health ministries across Cambodia, Ethiopia, Malawi, Nepal, Sudan, and Uganda, supporting regulated, semi-regulated, and emerging markets.

Can Plant 3 support commercial-scale manufacturing?

Yes. The facility offers scalable production capabilities across all five units, supported by validated utilities, robust quality systems, and continuous process improvement practices.

What quality systems support sterility assurance?

Sterility assurance is supported by validated aseptic processing, environmental monitoring, personnel qualification, sterilization validation, and electronic data integrity systems.

Advancing Sterile Manufacturing with Precision, Compliance & Global Quality