Optimus Pharma (p) Limited

Optimus has been set up by a team of young professionals who had more than 15 years of experience in Synthesis, production,Quality control, Quality Assurance & Regulatory requirements. Optimus objective to target complex and niche product portfolios for regulated as well as semi regulated markets has been the inspiration behind the launch of optimus.


At Optimus, the mission is to provide superior value to our customers by being innovative, focused & specialized. Optimus is one of the few Independent Indian API suppliers with Outstanding work force, Cutting edge Science, State- of- the art technology base & Knowledge intensive Initiatives. Optimus has been set up for working on Innovative solutions for tomorrows health care problems. We are recognized as  a strong partner in all major pharmaceutical markets in domestic as well as globally.

Quality & Regulatory:

Optimus is committed to deliver highest quality products by implementing and complying to various Quality systems through our Quality assurance & Quality Control Organisations.


Quality Systems/Compliance:

• Established Quality Systems(as per ICH) Quality systems got audited by several clients and got approved.

• GMP certifications/Quality certifications.

• Optimus facility has received ISO 9001: 2000  certification

• Optimus facility has received the WHO cGMP certification.

Quality Control Facility:

Optimus QC is equipped with state of the art quality testing equipments which are handled by  well qualified and trained personals to ensure the quality specifications of the products are met as per the customer requirements.


Quality control activities:

• Testing of samples to meet customer specifications.
  

• Control of all raw materials, Intermediates and final API.

• Chemical analysis, Instrumental analysis & particle size analysis.

• Control samples storage.

• Various analytical techniques are employed to meet customer specifications.

Quality assurance department:

Optimus quality assurance is mainly responsible for the site specific maintenance, compliance and realization of internal quality management system.The quality assurance guarantees that pharmaceutical ingredients and other products comply with the respective requirements and are developed produced, tested and released accordingly to WHO cGMP demands. The Quality control supports the quality assurance in the accomplishment of the WHO cGMP demands, mainly in the field of release analytics.


Quality Assurance activities:

• Document control.

• Review of all validation critical processes & procedures.

• Change control & deviations

• On going internal auditing, customer auditing and reviews.

• Complaints.

• GMP training.

• Product release.

• Annual product reviews.

Regulatory:

Optimus has well qualified Regulatory affairs team who supports various customers throught the world by providing regulatory guidance and documents required for regulatory submission.


Regulatory activities:

• Interactions with various regulatory bodies.

• Preparation & filing of DMF’s of Optimus API and address to queries from regulatory bodies.

• Assisting regulatory authorities during the audit period.

• Modern laboratory supported by state-of-the art instrumentation facility.

• Multipurpose plant with a combination of 20 GLR and SS reactors.

• 1 to 16 KL capacity high pressure SS/Glass/Hastallory auto cloves.

• WHO CGMP approved large volume plant.

• Multi purpose Blocks

• Established in the year 2003

• Loacted approx 50 Kms from Hyderabad city.

• Number of Employees-150+

• 2 production blocks for commercial production, 1 more under construction

• All production blocks with class clean room facility

• Complete onsite QA/QC/RA/R&D support

• Total volume of reactors 82 KL

• Type of reactions(capabilities): Brominations, catalytic hydrogenations,esterifications,

• Condensations,cyanations, Grignard reactions,optical resolutions,chloronations, Friedal-craft reactions,Hydrolysis,Sujuki coupling.

• ISO 9001: 2000 certified.

• WHO CGMP approved plant.

Mission:

Optimus mission is to provide superior value to its customers by being innovative, focused and specialized.


Vision:

Work towards building optimus pharma in top 20 pharma companies in India.

• Optimus has established world class infrastructure for manufacturing API’s complying with the requirements of regulated  & semi regulated markets.

• Our manufacturing plant is WHO GMP approved.

• We have manufacturing capabilities of multipurpose plant for manufacturing of validation quantities, from single to multi kilo lots.

• We have two multi purpose small to large volume blocks with volumes ranging from 50 ltr to 5000 ltrs capacity, with one focusing for semi regulated markets and other complying to US & EU regulatory requirements.

Optimus has a well experienced and qualified  process R & D team with organic chemistry capabilities at all the manufacturing blocks, who plays a significant role in providing technical support during commercialization of the product and to ensure the product is in line with the Regulatory & Quality requirements. The R &D team provides support at various stage of development which includes method development and validation, the synthesis and characterization of impurities, characterization of crystal forms, and the development of in process testing capabilities to successfully track the process through its synthesis. All the activities are practiced strictly under WHO CGMP guidelines.


Optimus process R & D focuses on the following:

• Develop Non- Infringing process.

• Impurities, characterization & Synthesis.

• Synthetic route evaluation of API from grams to kilo lots.

• Technology transfer services.

• Cost reduction & quality improvement.

• Analytical method development & validation.

• Customer Support.

• Development of environment friendly process.

• Development of chiral API’s.

• Ability to comply with the ICH guidelines.

• Analytical equipment from HPLC’s to GCS.

• 3 HPLC Make.

• Gas chromatography with Head space.

• Infrared spectrophotometer.

• Digital polarimeter.

• Ph Meters.

• Melting point apparatus.

• FTIR.

• Magnetic stirrers with Hot plant.

• Double beam UV visible spectrophotometer.

• Environmental chambers for performing stability studies.