Pioneering Quality & Excellence in
Active Pharmaceutical Ingredients
Chieron Active Ingredients Pvt. Ltd. is promoted by a prominent business house in India with extensive pharmaceutical experience spanning over four decades.
Who We Are & Our Global Footprint
Chieron has established a strong, recognized presence in specific critical therapeutic segments including Cardiovascular and Central Nervous System (CNS). The company continuously adds high-value molecules and expands its global footprint across North America, Europe, Japan, Korea, Brazil, and China.
Chieron stands as a pioneer manufacturer of unique niche Active Pharmaceutical Ingredients (APIs), holding prestigious approvals including six Certificates of Suitability (COS) from EDQM, USFDA approval, and Korean FDA (KFDA) approvals. We are actively pursuing filings with ANVISA (Brazil) and cFDA (China) for our key commercial products.
Our strategic focus on Backward Integration not only ensures cost competitiveness but also guarantees supply reliability and impeccable quality control across Key Starting Materials (KSMs) to finished APIs.
Our Core Mission (Since 2007)
“Delivering Best Quality and Cost Leadership in the supply of Intermediates & APIs to customers globally while achieving the highest levels of customer satisfaction.”
“At Chieron, sustainability drives innovation. Our goal is to build a business that is responsible, resilient, and ready for the future.”
Approved Manufacturing Sites & International Certifications
Our quality systems and regulatory filings are structured to satisfy the world's most stringent regulatory authorities.
USFDA
(United States)USFDA Approved
Approved Manufacturing Site for Active Pharmaceutical Ingredients
EDQM
(Europe)6 COS Approvals
Approved Sites & 6 Certificates of Suitability (COS)
PMDA
(Japan)PMDA Accredited
Accredited Foreign Manufacturer for Pharmaceutical Ingredients
KFDA
(South Korea)KFDA Approved
Korean FDA Approved Manufacturing & Quality Systems
ANVISA
(Brazil)ANVISA Active Filing
Approvals actively under pursuit for key commercial molecules
cFDA
(China)cFDA Active Filing
Filing and approvals actively progressing for global supply
Regulatory Agency & Scope Breakdown
Audit-Ready Facilities| Agency / Authority | Region / Country | Current Status | Scope & Accreditations |
|---|---|---|---|
| USFDA | United States | Approved | Approved Manufacturing Site for Active Pharmaceutical Ingredients |
| EDQM | Europe | Approved | Approved Sites & 6 Certificates of Suitability (COS) |
| PMDA | Japan | Accredited | Accredited Foreign Manufacturer for Pharmaceutical Ingredients |
| KFDA | South Korea | Approved | Korean FDA Approved Manufacturing & Quality Systems |
| ANVISA | Brazil | In Pursuit | Approvals actively under pursuit for key commercial molecules |
| cFDA | China | In Pursuit | Filing and approvals actively progressing for global supply |
Why Global Pharma Leaders Choose Chieron
Combining world-class R&D, backward integration, and certified high-capacity manufacturing.
Backward Integration
In-house production of key starting materials (KSMs) and advanced intermediates guarantees supply stability and protects against global raw material shocks.
Continuous Production
15 to 20 commercial APIs are maintained in continuous production, offering reliable 8 to 10 weeks maximum lead time for customer inventory optimization.
Dedicated Client Teams
Cross-functional teams led by R&D heads for innovators, and dedicated commercial execution teams for generic and specialty chemical partners.
Regulatory Trail Strength
Complete technical support for filing DMFs (US-DMF, CEP, Canada, Australia) with comprehensive genotoxic and nitrosamine impurity profiling.