[ Page 19 ] Certifications & Quality

Documented quality, from strain identity to release specification.

Bacospore® is manufactured through fermentation at Star Hi Herbs' Unit-2 (Pharma SEZ) in Hassan, Karnataka, India. Its quality framework combines documented strain identity, standardized viable-spore potency, defined purity limits and microbiological release specifications.

01 · Quality marks

Displayed on the Bacospore® 300B specification.

WHO GMP logo
Certification

WHO GMP

Good Manufacturing Practice quality system supporting controlled production, documented procedures, personnel hygiene and equipment maintenance.

ISO 9001 logo
Certification

ISO 9001

Documented processes, corrective actions, traceability and continual improvement across manufacturing and quality operations.

FSSC 22000 logo
Certification

FSSC 22000

Food Safety System Certification providing a robust quality framework to manage food safety hazards and ensure product safety.

Kosher logo
Certification

Kosher

Certification mark displayed on the Bacospore® 300B specification, supporting products for markets requiring Kosher ingredients.

Halal logo
Certification

Halal

Halal certification mark displayed on the 300B specification, supporting finished products for markets where Halal requirements apply.

FSSAI logo
Certification

FSSAI

Food Safety and Standards Authority of India certification, verifying compliance with national food safety, hygiene, and standards.

02 · Declarations

GMO-free and BSE/TSE-free status.

Bacospore® 300B is declared GMO-free and BSE/TSE-free in its approved product specification. The supplied grade uses maltodextrin sourced from tapioca as its excipient, and the specification confirms that the product is non-irradiated and is not treated with ethylene oxide.

03 · Strain identity

Verified strain identity.

MTCC 25308
Microbial Type Culture Collection & Gene Bank · India
ATCC PTA-126364
American Type Culture Collection · USA
04 · Facility

Facility credentials.

Manufactured by Star Hi Herbs Pvt. Ltd., Unit-2, Plot No. 105-B, Pharma SEZ, Koushika Village, Hassan, Karnataka, India. The approved specification identifies India as the country of origin and fermentation as the manufacturing process.

05 · Documentation

Certificates and documentation on request.

Batch-specific certificates of analysis, the Bacospore® 300B specification, technical data sheet, strain identification, GMO-free and BSE/TSE-free declarations, and non-irradiation and non-ETO statements are available to qualified evaluators from our quality team.

Evaluate Bacospore® in your next formulation.