Quality & Regulatory
How every batch is made, tested, documented and shipped.
Quality System
Every product is manufactured under a documented quality system aligned with GMP practices: traceability from raw material to dispatch, batch manufacturing records, release analysis against agreed specifications, and formal change control. Both the Sinnar (Nashik) and Erandol (Jalgaon) sites run under the same system.
Traceability
Batch records link each lot to its raw materials, process parameters and release results, so a certificate of analysis can always be traced back to the data behind it.
Impurity Control
Products are made with tight control on impurity profiles, supported by defined process parameters and QC verification against the specification agreed with you.
Change Control
Changes to process, raw material source or specification go through formal change control, so what you qualified is what you keep receiving.
Analytical & Development Capabilities
In-house analytical laboratories, an R&D lab and pilot plants support both manufacturing sites. Catalyst design, equipment design and process development are done in-house, which is what lets us scale a route from laboratory to commercial volume without handing it to a third party.
- Gas chromatography (GC) for assay and impurity profiling
- HPLC for non-volatile intermediates and related substances
- Karl Fischer titration for water content
- Pilot plants for scale-up and campaign trials
Core transformations
Processes we run at commercial scale, led by our liquid-phase catalytic hydrogenation technology.
Compounds outside the catalogue can be developed on these competencies. Describe what you need and our R&D team will respond with feasibility and timelines.
Documentation
Available on request for every catalogue product. Ask for them with your quote request or at any time afterwards.
COA
Certificate of Analysis per batch
MSDS / SDS
Safety data sheet
TDS / Specification
Product specification sheet
Certificate of Origin
For customs and preferential tariffs
Regulatory Compliance
- EU REACH. Products supplied into the European Union comply with the REACH regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals).
- MSME ZED Gold. The highest tier of the Government of India's Zero Defect Zero Effect certification, assessed by the Quality Council of India.
- Ecovadis. Rated on environment, labour and human rights, ethics and sustainable procurement.
- Halal and Kosher. Facility-wide certification covering production lines, raw materials and handling.
Green Chemistry
Catalytic hydrogenation replaces stoichiometric reagents with hydrogen and a recoverable catalyst, which is where our environmental record starts. Across the portfolio we apply green-chemistry principles wherever feasible: catalysis, solvent and process optimisation, waste minimisation and energy-efficient operation.
Between 1991 and 2005 the group developed green routes for over 50 products, work recognised by the Green Chemistry Award. See awards.
Packaging & Logistics
Both plants have efficient road access to JNPT (Nhava Sheva), Mumbai, for sea freight worldwide.
Liquids
Drums, IBC tanks and ISO tank containers, depending on volume.
Solids
Drums with LDPE or aluminium liner bags where the product requires it.
Export
Supplying 30+ countries; documentation prepared for the destination market.
Need a specification, COA or a supplier questionnaire filled?
Send the product and CAS number and our QA team will respond with the documents.