The role of R&D is crucial for the development of Dhanishta, therefore the company management places great emphasis on innovations that focus on the research and development of active pharmaceutical ingredients, intermediates, and specialized chemicals.

Company does the contract manufacturing of Intermediates and API's based on the requirement. And, We are also open to help companies in getting contract manufacturing units / Pilot scale plants for the production of intermediates and API's on contract basis to provide comprehensive services from Drug development to drug manufacturing.

We are an innovative CRO expertise in Custom synthesis, chemistry-driven, global service provider for pharmaceutical companies. We believe in quality work and timely deliverance of services are cost effective.

Dhanishta pharma has got its reliable and trustworthy Trading partners, R&D and Manufacturing partners across the globe whom we represent in the Indian market. China is our biggest strength in Imports.

WE PROVIDE LOCAL SOURCES AS IMPORT SUBSTITUTE FOR OUR CLIENTS WITH THE FOLLOWING SUPPORT: Alternative to China Document support for Regulated market. Audit Compliance as per WHO GMP/FDA. Stable Supplies and assured quantity. Transparency in communication for the client directly with the manufacturer.

We buy excisable goods from the Indian manufacturers and export to our various clients from our premises. We also handle exports done by Indian manufacturer directly to our overseas clients.

SOURCING EVALUATION IS DONE THOROUGHLY AS BELOW: Visit/ Verification of the real manufacturing site and coordinates. Product license/ Certifications available to the manufacturing site. Sourcing product status: campaign/ regular/ made against order & in-house standard specs/ MOA. Check whether they have basic cGMP systems. Product price history for past one year to six months. Installed capacity and % usage of the capacity at present. Check if the source has been audited by any company/ agency. Tech support with documents and Regulatory status. We provide Samples, Pre-shipment samples, Third Party Analysis if required

Analytical research and development for BBs, Intermediates, NCEs. Instrument calibration of systems as per schedule. Method development for reverse phase, normal phase and chiral HPLC systems using PDA, RI, CAD and ELSD detectors. Method development for OVI by GC analysis using GC HS. Comprehensive Impurity profile studies using LC MS and GC MS to elucidate the structure of compounds. Separation of compounds using prep HPLC for both achiral and chiral compounds. Preparation of tech pack and transfer of analytical methods to quality group. Identification of new polymorphs and salt screening studies in conjunction with Formulation team.

We are closely associated with a Regulatory service support partner to offer Quality/Regulatory Services. Listed below are some of them for reference. Review of NCEs, NMEs Chemistry and Manufacturing Controls (CMC) Design, Review and Qualification of Mfg., Laboratory, Packaging facilities Remediation of existing facilities to bring in compliance with QA/RA. Gap analysis Technology transfers, Batches execution, For-cause audits etc. Due diligence audits Clinical audits (GCP) Quality and Regulatory consultation during development of NCEs/NMEs Development Quality Assurance and RA CAPA management for clients QbD consultation

Dhanishta Pharma has got it expertise in sourcing Intermediates across Technical’ s for Agriculture and crop sciences companies In India and many other countries by adding value to their day to day supply chain management through our most reliable and trustworthy manufacturing partners in China.