WHO
GMP
GMP
WHO-GMP Certified
Certificate of Good Manufacturing Practices per WHO TRS No. 908 (2003).
Valid: 29-08-2023 to 28-08-2026
Certifications
WHO-GMP, GMP, GLP and ISO-certified manufacturing for beta-lactam, cephalosporins and general formulations.
Accreditations
Regulatory & quality certifications
Issued by Food Safety & Drug Administration, Uttarakhand for M/s Sucantis Biotech Pvt. Ltd., Plot No. E-127 & 128, Bahadrabad, Haridwar.
GMP
Sch M
Sch M
GMP — Schedule M
Revised Schedule M — Rules 71, 74, 76 & 78, Drugs & Cosmetics Rules 1945.
Issued: 02-05-2024 · Valid 3 years
GLP
GLP Certified
Good Laboratory Practices — Schedule L-1 (150-E), Drugs & Cosmetics Rules.
Issued: 02-05-2024 · Valid 3 years
ISO
9001
9001
ISO 9001:2015
Quality management systems across manufacturing operations.
Official documents
GMP — Schedule M
Issued 02-05-2024 · Valid 3 years
GLP Certified
Schedule L-1 · Issued 02-05-2024
WHO-GMP Certificate
WHO TRS 908 · Valid to 28-08-2028
Export Neutral Code
Granted 27-06-2024
Scanned certificates & export approval
Issued by Food Safety & Drug Administration, Uttarakhand for M/s Sucantis Biotech Pvt. Ltd., Plot No. E-127 & 128, Bahadrabad, Haridwar.
Licenses
Manufacturing licenses
Sucantis Biotech holds valid drug manufacturing licenses for oral solid and liquid oral dosage forms in segregated beta-lactam and non-beta-lactam categories.
- Form 25 — License No. 21/UA/2023
- Form 28 — License No. 19/UA/SC/P-2023
- Valid until 24-11-2028
- Export neutral code granted (27-06-2024)
Approved dosage forms: Tablets, Capsules (Hard Gelatin), Dry Syrup and Oral Dry Suspension — Beta-Lactam and Non-Beta-Lactam categories.
Export
Neutral code for export
Granted by Food Safety & Drug Administration, Uttarakhand for export of manufactured drugs:
- UK/Drugs/21/UA/2023 (Form 25)
- UK/Drugs/19/UA/SC/P-2023 (Form 28)
Supports third-party export supply of beta-lactam, cephalosporin and general formulations to international partners.
Quality Systems
Built-in quality assurance
QA leadership
Head QA with WHO-Geneva, Uganda FDA, Philippines, Tanzania, Kenya and Ghana inspection experience.
QC laboratories
GLP-compliant testing led by Head QC (Unit-I) with calibrated instruments, retained samples and documented release procedures.
Batch traceability
Batch manufacturing records, COAs, stability data and change-control documentation for partner audits.
Need certificates for a tender or audit?
Share your requirement and our quality team will respond with available documentation.
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