Manufacturing Site
Unit V – ARV APIs
Jeedimetla, Hyderabad
- Blocks
- 4
- Area
- 58,000 sq.ft
Classification
ISO 8 Clean Room
Manufacturer ProfileAPINEXA Verified
Hetero Drugs Limited
Hetero Drugs Limited
One of the world's largest ARV API producers with deep oncology capability and USFDA / EU GMP / WHO GMP / CEP coverage across 36 manufacturing sites.
- Headquarters
- Hyderabad, India
- Established
- 1993 · 33 years
- Company Type
- API Manufacturer · Exporter
- Region
- Hyderabad · APAC
Compliance Coverage
USFDAEU GMPWHO GMPCEPDMF
Verification & Trust
Pre-qualified, Compliance-Reviewed Supplier
APINEXA verifies every manufacturer for compliance, regulatory documentation availability, and active export capability before listing.
APINEXA Verified
Confirmed
Verified since May 2024
Compliance Review
Cleared
Documentation reviewed by APINEXA team
Export Status
Active
Supplying 126 countries
Match Score
91
AI-derived sourcing confidence
Documentation Availability
Audit-grade documentation pack
- DMF AvailableDrug Master File on request via NDA
- CEP SupportEDQM Certificate of Suitability
- COA per BatchCertificate of Analysis with every shipment
- Stability DataICH Q1A long-term stability available
- Audit ReportRecent third-party audit findings
All Certifications
USFDA
USFDA Site Inspection
U.S. Food & Drug Administration
Valid until Jun 2027
EU
EU GMP Certification
European Medicines Agency
Valid until Jan 2028
WHO
WHO Good Manufacturing
World Health Organization
CEP
Certificate of Suitability
EDQM
DMF
US Drug Master File
USFDA
Company Overview
About Hetero Drugs Limited
Hetero is one of India's leading vertically integrated pharmaceutical companies and the world's largest producer of anti-retroviral drugs. The company manufactures APIs, intermediates, biosimilars and finished dosage forms across a network of 36 manufacturing facilities supplying 126+ countries. Key therapeutic strengths include ARVs, oncology, cardiovascular, anti-infectives and gastrointestinal APIs.
Specialization
Anti-Retrovirals (ARV)Oncology APIsAnti-InfectivesCardiovascular APIsGastrointestinal
Core Strengths
Why buyers choose them
- World's largest ARV API producer
- Strong oncology capability with containment suites
- Cost-competitive commercial-scale supply
- Multi-site redundancy across India & China
Manufacturing Capabilities
Operational strength
Production capacity, technology platforms, and clean-room infrastructure verified at the manufacturer source.
Production Capacity
Mid-large · 600 MT/yr
- Batch size
- 20 kg – 3,000 kg per batch
- Annual capacity
- 600 MT/year aggregate
- Commercial scale
- Mid-large commercial scale with ARV specialization
Facility Footprint
36 manufacturing sites
- Plants
- 36
- Manufacturing blocks
- 7 blocks
- Clean-room classes
- ISO 8 Clean Room · ISO 7 Clean Room · Containment Suite
Technology Capabilities
Process technology
- HPAPI handling
- Containment manufacturing
- Sterile API capability
- Crystallization expertise
Product / API Portfolio
142+ APIs manufactured
A curated view of marquee molecules supplied by this manufacturer. Filter by therapeutic area to narrow results.
- Oncology
Lenalidomide
CAS 191732-72-6
USDMFWHO GMPActive ExportVery HighView API profile - Oncology
Imatinib Mesylate
CAS 220127-57-1
USDMFEU GMPStrong SupplyHighView API profile - Diabetes
Sitagliptin Phosphate
CAS 654671-77-9
USDMFActive ExportHighView API profile - Cardiovascular
Atorvastatin Calcium
CAS 134523-03-8
USDMFWHO GMPStrong SupplyVery HighView API profile
Regulatory Coverage
Export readiness across regulated markets
Authority-by-authority regulatory standing for major regulated and semi-regulated pharmaceutical markets.
Total Markets
5
Approved
4
Coverage
80%
| Region | Authority | Status |
|---|---|---|
United States | USFDA | Approved |
Europe | EU GMP / EDQM | Approved |
Brazil | ANVISA | Approved |
South Africa | SAHPRA | Approved |
Japan | PMDA | Filed |
Export Markets
Active exports across 126 countries
Live supply footprint grouped by market regulatory class — Regulated, Semi-Regulated, and Emerging.
Regulated Markets
2- United States
- Germany
Semi-Regulated Markets
2- Brazil
- South Africa
Emerging Markets
2- Nigeria
- Kenya
Export Statistics
126 countries · 6 highlighted
Active commercial exports across regulated markets, with documentation packs available per region.
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Facility & Infrastructure
Production sites & supporting infrastructure
Each facility is verified for clean-room class, production blocks, and built-up area.
Manufacturing Site
Oncology Block – Nakkapalli
Visakhapatnam, AP
- Blocks
- 3
- Area
- 44,000 sq.ft
Classification
ISO 7 Clean RoomContainment Suite
Supporting Infrastructure
R&D, QC, Warehousing & Stability
- Centralised QC laboratory complex
- Validated stability chambers
- Cold-chain warehousing for ARVs
Supply Capabilities
Procurement decision support
MOQ flexibility, lead times, packaging formats, and supply-flexibility signals to support procurement teams.
MOQ & Lead Time
Order flexibility
- Minimum order quantity
- 10 kg pilot · 200 kg commercial
- Lead time
- 5 – 10 weeks
- Contract manufacturing
- Supported
- Long-term supply
- Multi-year contracts
Packaging Options
Standard packaging formats
- 25 kg HDPE drumsValidated packaging meeting export-grade requirements.
- Aluminium bags within HDPEValidated packaging meeting export-grade requirements.
Certifications & Documents
Downloadable documentation pack
Secure document access. Restricted documents require an NDA submitted through the RFQ form.
RFQ / Supplier Contact
Contact Hetero Drugs Limited
Send a structured inquiry routed through APINEXA's coordination team — confidential, compliance-pre-checked, audit-grade. Typical response in 8 hours.