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Quality first

Quality you can verify — not just claim.

Sada Pharma operates a quality management system certified to ISO 9001:2015, so that every batch meets the chemical specification agreed for it. Three disciplines carry that commitment: analytical rigour, comprehensive documentation, and EHS and process safety.

01Analytical & documentation capability
HPLC
Assay, related substances, purity
Gas chromatography
Residual solvents & volatiles
Wet analysis
Titrimetric & gravimetric methods
Karl Fischer
Moisture content titration
Certificate of Analysis
Batch-wise COA with every consignment
MSDS / SDS
Safety data for handling & transport
Route of Synthesis
ROS disclosure on request, under NDA
EHS & solvent recovery
Environmental, health & safety practice
02Certification ISO 9001:2015

Certified, and checkable.

Our quality management system is certified to ISO 9001:2015 for the manufacture of pharmaceutical intermediates, advanced intermediate materials and rare chemicals at our Humnabad works. The certificate is reproduced here in full, with its number, so that it can be verified against the issuing body's own registry rather than taken on trust. Certificates for any other standard we hold can be supplied against enquiry.

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Standard
ISO 9001:2015 — quality management systems
Scope
Manufacturing of pharmaceutical intermediates, advanced intermediate materials and rare chemicals
Certified site
Plot No. 80-P1, Humnabad, KIADB Industrial Estate, Gadawanti, Bidar, Karnataka 585353, India
Certificate no.
QMS-MMXXV-06-15638
Issued by
WRG Certifications
Valid
6 June 2025 – 5 June 2028, subject to surveillance audits in May 2026 and May 2027
NACE code
DG-24.40

01 · Analytical rigour

Modern analytical laboratory capabilities underpin every specification we agree. Analysis is not treated as a gate at the end of a campaign — the method is developed alongside the chemistry, so that by the time a batch is made, the means of proving it already exists and has been shown to work.

  • High-Performance Liquid Chromatography (HPLC) — assay, related substances and purity determination across the catalogue.Assay · Related substances
  • Gas Chromatography (GC) — residual solvents and volatile impurities, including the solvents carried in from earlier steps.Residual solvents · Volatiles
  • Wet analysis — titrimetric and gravimetric methods where they remain the most reliable measurement available.Titrimetric · Gravimetric
  • Moisture titration (Karl Fischer) — water content determination, which for many intermediates is the specification that decides downstream yield.Karl Fischer

02 · Comprehensive documentation

Full regulatory support accompanies what we supply. Our customers file with regulators; the documentation we provide has to survive that scrutiny rather than merely accompany a delivery note.

  • Certificate of Analysis (COA) — batch-specific, issued against the agreed specification with every consignment.Per batch
  • Material Safety Data Sheets (MSDS / SDS) — safety data for handling, storage and transport.Per product
  • Route of Synthesis (ROS) disclosure — provided on request under confidentiality where your submission requires it.Under NDA
  • Impurity tracking — impurity profiles recorded and trended batch to batch, not merely measured once at qualification.Batch to batch

03 · EHS & process safety

We adhere to Environmental, Health and Safety (EHS) standards across our operations. Robust solvent recovery systems and defined chemical handling protocols are part of how a route is designed, not a compliance layer applied to it afterwards — a route that cannot be run safely and cannot recover its solvent is not a route we consider finished.

  • EHS standards — environmental, health and safety practice applied across operations.Operational
  • Solvent recovery — robust recovery systems, with recovery treated as a design parameter of the route.Design parameter
  • Chemical handling protocols — defined handling, storage and disposal procedures for every material we process.Handling · Storage · Disposal
  • Green chemistry & waste reduction — a standing commitment to green chemistry principles and safe environmental practices.Sustainability

04 · Supply chain integrity

Quality that only appears in the qualification batch is not quality. Our commitment is to assured on-time delivery, batch-to-batch consistency and transparent procurement processes — so that an intermediate qualified once into your route keeps meeting the same specification on every campaign that follows, and you are never re-qualifying a material you have already approved.

Uncompromising adherence to purity benchmarks and regulatory compliance is the first of our values, and it is the one the other two depend on. If a batch does not meet specification, it does not ship.

Request a specification or COA