Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
HIKAL is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:India
Founded:2009
Employees:1,948
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Europe
Manufacturing Facilities
2 sites worldwide
Hikal Limited
Plot No. 629/630-B, GIDC Estate, Panoli, Bharuch, Gujarat, 394116
Site Capabilities
1 capabilityAPI MANUFACTURE
Hikal Limited
72 & 82/A, KIADB Industrial Area Jigani, Anekal Taluk, Bengaluru, Karnataka, 560105
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
4
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval LLW7GV
EMA · #APR-V4Z8RS34 · 2021-08-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-OIHZKOUC
Issued: 2020-06-04
Expires: 2025-06-24
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-MR82ES5C
Issued: 2020-10-05
Expires: 2025-12-17
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-SY76MVDL
Issued: 2020-06-27
Expires: 2025-02-18
Loading CDMO intelligence...
Key facts about HIKAL
- HIKAL is headquartered in India.
- HIKAL was founded in 2009.
- HIKAL has 1,948 employees.
- HIKAL has 2 manufacturing sites listed on CDMO Hub, in Bharuch, India and Bengaluru, India.
- HIKAL's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
Find CDMOs like HIKAL
Directory pages this company appears in, each with the full list of matching manufacturers.