Manufacturing Infrastructure
Fully automated. WHO-GMP certified. Independently approved by five international regulatory authorities. Located at Rudrapur, Uttarakhand. Continuously operational since 2007.
Manufacturing Infrastructure — FDFs
Not Just Compliant.
Independently Verified.
The SNDEV manufacturing plant at Jai Nagar-3, Dineshpur Road, Rudrapur is a fully automated, multi-category pharmaceutical manufacturing facility operating under WHO-GMP certificate No. 17P/1/96/2007, issued by the Food Safety & Drugs Administration Authority, Uttarakhand — valid through April 2026.
The facility was joint-inspected on 26-03-2023 and 21-03-2023 and found compliant with Good Manufacturing Practices for all dosage forms, categories, and activities listed in the manufacturing licence. The certificate confirms the facility follows WHO-TRS guidelines in manufacturing and testing.
GMP Certificate — Verified Details
- Jai Nagar-3, Dineshpur Road, Rudrapur — 263 153, Uttarakhand
- WHO-GMP Certified · Cert. No. 17P/1/96/2007 · Valid through April 2026
- Mfr. Licence: Form 25 — 47/UA/2007 · Form 28 — 96/UA/NC/P/2007
- Tablets · Capsules · Oral Liquid · Sterile & Non-Sterile Ointments · Parenterals
- Independent QA/QC laboratories on-site · Validated analytical methods
Jai Nagar-3, Dineshpur Road, Rudrapur — 263 153, Uttarakhand
WHO-GMP Certified · Cert. No. 17P/1/96/2007 · Valid through April 2026
Mfr. Licence: Form 25 — 47/UA/2007 · Form 28 — 96/UA/NC/P/2007
Tablets · Capsules · Oral Liquid · Sterile & Non-Sterile Ointments · Parenterals
Independent QA/QC laboratories on-site · Validated analytical methods
Quality Assurance & Control
QA Does Not Report to Production Here.
At SNDEV, QA and QC are independent functions. A batch that does not meet specification is not released — regardless of delivery timelines.
Raw material testing before production entry
Identity, purity, and potency testing of every raw material before release to the manufacturing floor.
Finished product testing — assay, dissolution, uniformity
Comprehensive finished product QC including assay, dissolution, content uniformity, microbial limits, and all applicable pharmacopoeial tests.
Validated analytical methods
All analytical methods are validated per applicable ICH/WHO guidelines. Instruments calibrated on documented schedule.
In-process controls at defined stages
In-process samples tested at defined intervals — weight variation, hardness, dissolution, pH, viscosity per dosage form.
Independent QA batch release
Batch release is the sole authority of QA — not production, not sales, not logistics. No exceptions.
Deviation management — root cause analysis
All deviations documented, investigated, and closed with root cause analysis. QA documentation reviewed and accepted by five international regulatory authorities.
Raw material testing before production entry
Identity, purity, and potency testing of every raw material before release to the manufacturing floor.
Finished product testing — assay, dissolution, uniformity
Comprehensive finished product QC including assay, dissolution, content uniformity, microbial limits, and all applicable pharmacopoeial tests.
Validated analytical methods
All analytical methods are validated per applicable ICH/WHO guidelines. Instruments calibrated on documented schedule.
In-process controls at defined stages
In-process samples tested at defined intervals — weight variation, hardness, dissolution, pH, viscosity per dosage form.
Independent QA batch release
Batch release is the sole authority of QA — not production, not sales, not logistics. No exceptions.
Deviation management — root cause analysis
All deviations documented, investigated, and closed with root cause analysis. QA documentation reviewed and accepted by five international regulatory authorities.
CRAMS Services
The Complete Pharmaceutical Outsourcing Cycle.
pharmaceutical companies seeking a compliant, multi-jurisdiction certified CRAMS
base in India.
Formulation Development & Scale-Up
Pre-formulation studies, prototype development, analytical method development, and scale-up from lab to commercial batch — with full documentation for regulatory submission.
Technology Transfer
Transfer of existing formulations from originator facilities — with full validation, equivalent batch studies, and documentation suitable for regulatory submission in target markets.
Contract Manufacturing — GMP Batches
WHO-GMP certified contract manufacture across all five categories: Solid Orals, Liquid Orals, SVPs, Sterile Topicals, and Non-Sterile Topicals. Under your brand. Under our quality systems.
Regulatory Dossier Preparation
CTD and market-specific dossiers for Cambodia, Kenya, Nepal, Yemen, Ivory Coast, and other markets in our registration network. We are approved in them — we know them.
Market-Specific Packaging & Labelling
Primary and secondary packaging configured to target market requirements — labelling in required languages, child-resistant packaging where mandated, specifications per market standards.
Quality Partnership & QA Support
QA documentation packages for partner audits, stability data for registration dossiers, ongoing technical support, and site audit readiness — so your supply stays uninterrupted.
Formulation Development & Scale-Up
Pre-formulation studies, prototype development, analytical method development, and scale-up from lab to commercial batch — with full documentation for regulatory submission.
Technology Transfer
Transfer of existing formulations from originator facilities — with full validation, equivalent batch studies, and documentation suitable for regulatory submission in target markets.
Contract Manufacturing — GMP Batches
WHO-GMP certified contract manufacture across all five categories: Solid Orals, Liquid Orals, SVPs, Sterile Topicals, and Non-Sterile Topicals. Under your brand. Under our quality systems.
Regulatory Dossier Preparation
CTD and market-specific dossiers for Cambodia, Kenya, Nepal, Yemen, Ivory Coast, and other markets in our registration network. We are approved in them — we know them.
Market-Specific Packaging & Labelling
Primary and secondary packaging configured to target market requirements — labelling in required languages, child-resistant packaging where mandated, specifications per market standards.
Quality Partnership & QA Support
QA documentation packages for partner audits, stability data for registration dossiers, ongoing technical support, and site audit readiness — so your supply stays uninterrupted.
Partner With SNDEV Healthcare
For CRAMS enquiries, contract manufacturing, or distribution partnerships
— our business development team is ready.