We engage across a wide variety of development services along the life cycle of your new ideas. The range of our services includes:
Our capabilities include formulation development, technology scale-up and full-scale commercial manufacturing. We have capabilities for both solid and liquid pharmaceutical dosage forms.
Our Key Offerings:
FORMULATIONS
Solid Pharmaceutical Dosage Forms
Liquid Pharmaceutical Dosage Forms
Packaging
We are focused on developing and launching new complex generic products containing APIs i) which are difficult to handle or formulate , ii) needs extended release profile (iii) needs pairing with a device to make a drug-device combo primarily in solid and liquid pharmaceutical dosage forms to provide specialized capabilities to our customers especially for high potency, controlled substances and low-solubility products.
Our R&D laboratories (which include formulation development, analytical development and chemical research areas) are located at Dehradun Plant – I, and are recognized as an in-house R&D unit by the Department of Scientific and Industrial Research, Ministry of Science and Technology, Government of India.
We use our own R&D resources to develop, optimize and standardize our formulation and manufacturing process, and conduct the required stability testing as well as conduct clinical studies through qualified third party contract research organizations to obtain the requisite regulatory licenses required to manufacture such complex generic products. Further, the development and manufacturing of complex generic products typically involves a higher degree of expertise/ trained manpower and also utilizes higher overall process times. Our complex generic products portfolio primarily comprises fixed dosage combinations, fixed dosage plus modified release combinations, customized generics and chewable or dispersible.
Maintaining high standard of quality in our R&D and manufacturing operations is critical in Pharmaceutical field. We have implemented high quality systems across our manufacturing facilities that cover the full product lifecycle from process innovation and R&D, through the stages of process development, manufacturing, sales, and supply chain, to the customer evaluation of our products as well as management systems for ensuring consistent quality, efficacy, and safety of our products. We identify and approve multiple vendors to source our key raw materials pursuant to robust vendor assessment, in addition to the suppliers approved by our customers.
We have one quality staff for every three individuals engaged in our manufacturing operations. Our quality function has two separate departments:
Quality Assurance Department: The department prepares standard operating procedures, oversees new product/ vendor introduction in accordance with the regulatory approval, oversees the compliance of facilities and equipments to current GMP, handles product quality related complaints, manages process deviations, change controls, risk analysis, internal audit, product recalls, personnel trainings, issues all production documentation and maintains all executed records and provides oversight to other functions with respect to compliance to current GMP expectations.
Quality Control Department: This department manages the laboratory test infrastructure required to test materials (raw, in-process and finished goods and stability studies) as per pre-set standards and specifications which is used to release a product to the market by the quality assurance department.
Our products undergo a qualification process throughout the entire life cycle from development to technology transfer to high volume manufacturing. The bill-of-materials, test specifications, test methods and manufacturing processes are all standardized and validated for every product based on historical data and risk assessments. We have also made significant investments in quality management systems and have moved from a ‘paper-based’ approach to ‘electronic-based’ systems in manufacturing and quality controls as well as validation activities which enable us to undertake data analytics and track product level information across the different facilities and teams.
Implementation of our quality policy is done through quality management systems based on WHO GMP and Schedule M in conformity other applicable national standards. Periodic self-inspections and audits are conducted to monitor the effective implementation of quality systems. We are assessed periodically in accordance with applicable GMP. Our manufacturing facilities are regularly inspected for compliance with current GMP and all our manufacturing facilities are Schedule M compliant. Further, our Dehradun Plant – I, Dehradun Plant – II and Dehradun Plant – IV are compliant with standards set by WHO GMP.
We are required to comply with the regulatory requirements of various local, state, provincial, national and international regulatory bodies having jurisdiction in the countries where we manufacture products or where our customers’ products are distributed. In particular, we are subject to laws and regulations concerning research and development, testing, manufacturing processes, equipment and facilities, including compliance with current GMPs, labeling and distribution, import and export, and product registration and listing.
