Formulation Development & Analytical Development Lab (Unit – I, Bhayla Location)
Cubit Life sciences believes that Research & Development is the growth engine for its foray into the regulated and semi regulated markets. All R&D initiatives are guided by the organizational philosophy of providing affordable yet high quality medicines for health care and wellness.
With belief of quality based product development and concept that “Research is creating new knowledge”, Cubit has set own product development lab set up with ultra-modern equipment having small scale and with similar design and working principles as to commercial manufacturing facility where all products are developed with and approach of QBD (Quality by design) and transferred systematically for commercial scale.
Products are developed by expert scientist with required evaluation of drug product molecule for mainly oral solid dosage forms and other dosage forms.
In support of F&D a well-designed Analytical development department equipped with modern analytical instruments and with team of qualified analyst to support the development function. ADL performs the analytical method development and method transfer activities.
F&D team focuses on development of specialized formulations like sustain release, dispersible type, delayed release type and bilayer controlled release formulations along with IR formulations.
F&D team mainly focus to develop the products which are stable, cost effective and with an optimized process and smooth technology transfer concept based design right from starting to pre formulation study to final stability study as per ICH guidelines.
Products are transferred for higher scale manufacturing by following approved procedure of technology transfer with required evaluation of product development parameters and analytical development datas.
Scientist of F&D and ADL lab are having Strong background of educational qualification and rich experience to execute the product and analytical development activities.
DSIR approval and recognition is under progress for F&D lab.
Manufacturing Unit – I - Bhayla Location
A 100 % Export oriented manufacturing unit is created and qualified for manufacturing of oral solid dosage forms (Tablets and capsules) spread over 7500 Square meter area and equipped with the state of art machineries with semiautomatic to an automatic control system with modernized concept of man and materials movement as per the national and international regulatory guide lines and compliances.
Facility has been approved by FDCA Gujarat State and WHO cGMP along with regulatory authority of various worldwide markets with required inspection at regular intervals.
Manufacturing facility has capacity to produce the 800 MN units of tablets and 200 MN units of capsules dosage forms with provision of expansion of capacity in future.
Manufacturing, packaging and materials handling operations are supervised and controlled by the qualified, competent and trained team members under guidance of highly experienced Management Team.
Materials used for manufacturing and packing activities are procured from approved vendors and quality based DMF grade as per the regulatory requirements and norms.
Company has its own warehouses for storage of materials and finished products to store in safe and effective manner with required control of temperature and humidity (as applicable) till distribution of products.
A well experienced engineering team handling utility equipments to supply the purified water, Environment control from HVAC system, steam supply and compressed air system for manufacturing requirements as per the norms of regulatory guidance.
With philosophy “We Believe in Quality “Unit – I has been supported by well-established In house quality control and microbiology laboratory set up to perform the analysis of raw materials, packing materials and finished drug products as per the approved and stringent specifications.
We are endowed with a rich pool of experienced QC team acting as drivers of growth, to raise the laboratory’s capabilities to global standards.
QC lab is set with modernized instruments to perform the in – House analytical test to give assurance and guarantee for the results along with purity safety and efficacy of products.
In – house QC lab resulted achieving results for analysis in timely and accurate manner as a part of product quality checks.
For data generation, collection, evaluation and processing of data manufacturing, QC and warehouse is set up with strong IT set up with latest software and instruments.
Monitoring of quality throughout the life cycle of product is the most important aspects for patient’s safety and ultimate success of company.
Cubit has well planned QA & RA team set up ,to monitor the quality right from starting raw materials to finished product stages Cubit has well defined and qualified team of quality assurance with full dedication and adherence to quality policy and approved quality management system.
Our QA team is always trying their best to monitor and control the predefined specifications of product at all stage of manufacturing, storage and distribution. Products are only released for market distribution after approval from QA with required review of Manufacturing Documents, Analytical results and comparison with approved specifications.
QA plays a vital role in process validation, product stability studies, cleaning validation and market complaint handling along with self-inspection of facility at regular time intervals.
Regulatory team of Cubit is the core strength of company based on their highly experience and qualified team members aware the all other departments for regulatory updation, prevalent regulations and technical supports to generate and compile the quality dossiers.
In dossier bank of RA Cubit has more than 75 dossier and many others are under progress. RA prepares the dossier as per the regulatory requirements in form of CTD, eCTD and ACTD forms as per the company and client requirements.
Manufacturing Unit – II - Bhayla Location
With concept of 100 % supply to domestic product requirements is under conceptualization and erection for all type of dosage forms like tablets, capsules, Liquids, Dry powders and ointment With Target to be operational by 2023.
