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About IIL

Manufacturing Capabilities

IIL has set up a new state of the art facility located in the Genome Valley at Karkapatla around 70 kms from Hyderabad, India. Spread over a vast land bank of 48 acres (200,000 Sq Mtr) it has independent and separate blocks for Vaccines and Small Molecule Formulations. The contract manufacturing opportunities are focused around our formulation unit which caters to production for both Human Health and Animal Health products. The formulations units are two distinct blocks one covering Oral Solid Dosage forms and the second one for Small Volume Parenteral. Our capacities for each of these dosage forms is as captured below.

Capacities (per Annum)

Tablets  : 300 million
Bolus  : 100 million
Injections  : 20 million

The plant is a state of the art facility with the latest equipment including automated granulation and compression lines and a state of the art integrated product development line. Scaling up of capacities is not a constraint for committed volumes.

Building Management System

The plant boasts of a world class fully automated, remotely monitored and managed Building Management System. Building management system (BMS) shall be a central monitoring & controlling system. The Building management system shall carry out the monitoring and controlling of various parameters in HVAC system. The Direct Digital Controllers (DDC) of AHU shall be monitoring, controlling and communicating with the central BMS. Temperature, Relative Humidity and Differential Pressure Sensors are all monitored and controlled through the central control system. Any deviations from the stipulated range will activate alarms which get recorded in the BMS system and an immediate control action is initiated. The control system software shall be compliant as per 21 CFR Part 11.

Quality Assurance and Quality Control

Quality is at the core of our business philosophy. Our operations, systems, processes and training is all oriented towards a “No Compromise” ideology. Our adherence to this all-encompassing quality system is reflected in our “INTEGRATED MANAGEMENT SYSTEM POLICY” as captured below.

We produce and deliver safe and efficacious bio- pharmaceuticals using environmental friendly processes and by giving due importance to the health & safety of employees and the society.

We achieve this through continual improvement of the integrated management system, manufacturing processes, industrial safety measures and improvement of the competencies of the personnel working for us.

We are committed to prevent pollution of the environment and prevent injury and damage to health of our people in their work environment. In this respect, we will comply with all statutory and regulatory requirements.

We are also committed to enhance customer satisfaction and experience of customers with our products and services.

IIL has the following key Quality Management System accreditations:

  • ISO – 9001 : 2008
  • ISO – 14001 : 2004
  • BS OHSAS : 18001:2007

 

Our Quality Control infrastructure for the Animal Health business also includes:

  • Small Animal testing facility
  • Large Animal Testing Facility
  • Veterinary Services Department for field trials
  • IIL Network with National and International Institutes for R&D and Trials

 

The formulations unit at our new facility is designed to comply with some of the most stringent international regulatory standards such as:

  • US FDA
  • UK MHRA
  • Australia, TGA
  • Brazil, ANVISA

 

We are seeking partners for contract manufacturing for both Human Health Formulations and Animal Health Formulations for Oral Solid Dosage forms and Small Volume Parenteral. We have the expertise and capabilities to both initiate site change activities (contract manufacturing) and undertake development projects. We solicit cooperation proposals to build synergistic relationships.

Sarthak Vasudeva
Head – International Business

v.sarthak@indimmune.com

Dir : +91 40 2354 1326

Mob: +91 7658 929 444

 

HEAD OFFICE

Road No. 44, Jubilee Hills, Hyderabad-500033, India.

PLANTS

  • Veterinary Biologicals, Rakshapuram, Gachibowli, Hyderabad – 500032, India.
  • Human Biologicals, Gachibowli, Hyderabad – 500032, India.
    Human Biologicals, Udhagamandalam, Tamil Nadu – 643007, India.
  • Animal Health Formulations Genome Valley, Phase III, Karkapatla, Hyderabad, Telangana, India.