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Home
About Us
Company Overview
Strategic Acquisition
Leadership Team
Products
Product List
API Products
Intermediates Under Devlopement
Parents Company Intermediate
API (Suleshvari Pharma)
API (Hemdeep Organics)
Quality
QC Laboratory
Quality Policy
Safety Policy
Infrastructure
Regulatory
Global Filings
Approval Timeline
Inspections
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Home
About Us
Company Overview
Strategic Acquisition
Leadership Team
Products
Product List
API Products
Intermediates Under Devlopement
Parents Company Intermediate
API (Suleshvari Pharma)
API (Hemdeep Organics)
Quality
QC Laboratory
Quality Policy
Safety Policy
Infrastructure
Regulatory
Global Filings
Approval Timeline
Inspections
Home
About Us
Company Overview
Strategic Acquisition
Leadership Team
Products
Product List
API Products
Intermediates Under Devlopement
Parents Company Intermediate
API (Suleshvari Pharma)
API (Hemdeep Organics)
Quality
QC Laboratory
Quality Policy
Safety Policy
Infrastructure
Regulatory
Global Filings
Approval Timeline
Inspections
Approval Timeline
Factory License
India · Statutory factory registration
Received
Gujarat Pollution Control Board (GPCB) License
Gujarat, India · Environmental compliance approval
Received
Manufacturing License
FDCA, Gandhinagar
April 2026*
WHO GMP Certificate
World Health Organization · Good Manufacturing Practice
May 2026
Written Confirmation (WC)
EU Written Confirmation for API export
June 2026
Submission to Regulatory Authorities
Filing dossiers to PMDA (Japan), CEP (Europe), NMPA (China), and TFDA (Taiwan).
June 2026
Approval / Accreditation
Final regulatory accreditation across all target markets
August 2026
