Proven R& D:

Process Development

We believe in history’s lessons that companies with strong Research & Development foundations will see far more success than those without. Acting on this belief, we established our R&D laboratory in October 2015, long before commencing our commercial manufacturing operations, with a focus on robust process development.

Our main strength is our people, who have core R&D experience from other highly successful and reputed organizations. Our Senior Management team has a collective experience of 100 years in R&D, with a proven track record of helping the companies grow significantly with their contributions. We are also well-staffed with a balance between experience and qualified young talent, which has been recruited from top universities in India.

We understand the market requirements, maintain cost competitiveness and strive to work on developing the most cost-effective and non-infringing processes by adopting the latest trends in chemistry.

We are committed to develop robust, cost effective, scalable and non-hazardous processes by following the steps mentioned below:

• Extensive literature survey and evaluation of patent landscape
• Brain storming sessions to finalize the synthetic scheme/s
• Completion of feasibility and a full length process optimization at lab
• Protecting the inventions by filing patent applications to have Free to Operate position
• Identification of potential impurities and synthesizing impurities at lab level
• Setting the critical parameters of the processes and mitigation plan incase of any process deviations
• Recovery and reuse of solvents/reagents/catalysts to check the process capability
• Process validations at lab level
• Support to analytical research team for the development of best suitable analytical method
• Adopting structured review mechanism over the process during optimization stage
• Generation of technical documents to support the customers

We can address the queries of various regulatory authorities with supporting documentation upon the request of our customers for their finished product approvals.

Analytical Research and Development:

Our management team supports the AR&D team efficiently by developing suitable analytical methods to identify impurities at various phases of product development. They are well-versed in analytical method development, preparation of method of analysis reports, analytical method validations and transfer of analytical documents to the Quality Control team.

Our team can develop alternate methods that meet ICH specifications. They have considerable experience in API, intermediate, raw material characterization and reference standards with the help of sophisticated analytical equipment.

We evaluate genotoxic impurities immediately after process optimization and show the limit of detection at an appropriate stage of the process. We support our customers by providing the intermediate holding study data, stability data for intermediates and APIs at various stability conditions. The end-to-end analytical documents are archived systematically in high secured servers.

World-Class Facilities:

Our R&D laboratory located in Hyderabad is modern and fully functional, while state of the art greenfield manufacturing plant is near Vishakhapatnam.

Manufacturing

• Plant located near Achutapuram in a 10 acre layout.  Currently the facility buildings occupy only 25% of the space. 
• Intermediate block with Reactors,  two suites of clean rooms for API manufacturing, Pilot plant with reactors
• cGMP followed in the entire plant area with all SOPs in place and being implemented from day one of starting operations
• COE and CFE obtained form AP Pollution Control Board
• All the statutory licenses including Fire safety, usage of Methanol, Ethanol, Acetic Anhydride in place
• 41 reactors with a total volume of ~122 KL. Civil construction ready for adding further ~80 KL capacity.
• Hydrogenation block with capacity pressure
• sq.ft of ware house, with segregation of spaces for low temperature and room temperature.
• All the utilities are built keeping in view the requirements for future expansion
• any other points

Quality Control and Quality Assurance

• All SOPs are in place and being implemented in all the areas including production, warehouse, Quality Control etc.
• The plant has been successfully audited by some of the big generic companies
• Senior teams in QC and QA, including the management are highly experienced in handling successful  regulatory audits by global health authorities. 
• Innovare is highly committed to support our customers by sharing the authentic documentation for hassle free regulatory approvals.