Manufacturing Site
Unit IX – API
Pashamylaram, Hyderabad
- Blocks
- 6
- Area
- 98,000 sq.ft
Classification
ISO 7 Clean RoomContainment Suite
Manufacturer ProfileAPINEXA Verified
Aurobindo Pharma Ltd
Aurobindo Pharma Limited
Vertically integrated global API manufacturer with USFDA, EU GMP and PMDA compliant facilities supplying regulated markets across 6 continents.
- Headquarters
- Hyderabad, India
- Established
- 1986 · 40 years
- Company Type
- API Manufacturer · CDMO · Exporter
- Region
- Hyderabad · APAC
Compliance Coverage
USFDAEU GMPWHO GMPCEPPMDADMFISO 9001
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 Mar 2024
Compliance Review
Cleared
Documentation reviewed by APINEXA team
Export Status
Active
Supplying 155 countries
Match Score
96
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 Apr 2028
EU
EU GMP Certification
European Medicines Agency
Valid until Nov 2027
WHO
WHO Good Manufacturing
World Health Organization
CEP
Certificate of Suitability
EDQM
Valid until Jul 2029
PMDA
PMDA Approval
Pharmaceuticals & Medical Devices Agency, Japan
Valid until Dec 2027
DMF
US Drug Master File
USFDA
ISO
Quality Management
International Standards Org.
Valid until May 2027
Company Overview
About Aurobindo Pharma Ltd
Aurobindo Pharma is one of the largest vertically integrated pharmaceutical companies in India with a strong global footprint across regulated markets. The company manufactures Active Pharmaceutical Ingredients (APIs), generic finished dosage forms, and biosimilars across multiple therapeutic categories. With a presence in over 150 countries, Aurobindo operates 25+ manufacturing facilities — many of which are USFDA, EU GMP, WHO GMP and PMDA inspected — supporting commercial-scale supply for global generic, branded and innovator partners.
Specialization
Cardiovascular APIsAnti-RetroviralsOncology APIsCNS APIsAntibiotics
Core Strengths
Why buyers choose them
- Vertical integration from KSM to finished dosage
- Regulated-market export readiness
- Flexible MOQ — pilot to commercial
- Multi-site redundancy across India & Portugal
Manufacturing Capabilities
Operational strength
Production capacity, technology platforms, and clean-room infrastructure verified at the manufacturer source.
Production Capacity
Large scale · 800+ MT/yr
- Batch size
- 50 kg – 5,000 kg per batch
- Annual capacity
- 800+ MT/year aggregate
- Commercial scale
- Commercial-scale supply with multi-site redundancy
Facility Footprint
11 manufacturing sites
- Plants
- 11
- Manufacturing blocks
- 15 blocks
- Clean-room classes
- ISO 7 Clean Room · Containment Suite · Sterile Block · ISO 8 Clean Room
Technology Capabilities
Process technology
- HPAPI handling
- Fermentation
- Lyophilization
- Peptide synthesis
- Continuous manufacturing
Product / API Portfolio
287+ APIs manufactured
A curated view of marquee molecules supplied by this manufacturer. Filter by therapeutic area to narrow results.
- Cardiovascular
Atorvastatin Calcium
CAS 134523-03-8
USDMFCEPEU GMPStrong SupplyVery HighView API profile - Diabetes
Metformin HCl
CAS 1115-70-4
USDMFWHO GMPStrong SupplyVery HighView API profile - Cardiovascular
Rosuvastatin Calcium
CAS 147098-20-2
USDMFCEPStrong SupplyHighView API profile - Oncology
Lenalidomide
CAS 191732-72-6
USDMFEU GMPActive ExportVery HighView API profile - Cardiovascular
Clopidogrel Bisulfate
CAS 120202-66-6
USDMFCEPWHO GMPStrong SupplyHighView API profile - Diabetes
Sitagliptin Phosphate
CAS 654671-77-9
USDMFEU GMPActive ExportHighView API profile
Regulatory Coverage
Export readiness across regulated markets
Authority-by-authority regulatory standing for major regulated and semi-regulated pharmaceutical markets.
Total Markets
8
Approved
7
Coverage
88%
| Region | Authority | Status |
|---|---|---|
United States | USFDA | Approved |
Europe | EU GMP / EDQM | Approved |
Japan | PMDA | Approved |
Brazil | ANVISA | Approved |
Australia | TGA | Approved |
South Korea | MFDS | Filed |
Mexico | COFEPRIS | Approved |
Russia | Roszdravnadzor | Approved |
Export Markets
Active exports across 155 countries
Live supply footprint grouped by market regulatory class — Regulated, Semi-Regulated, and Emerging.
Regulated Markets
6- United States
- Germany
- United Kingdom
- Japan
- Australia
- Canada
Semi-Regulated Markets
4- Brazil
- South Africa
- Russia
- Mexico
Emerging Markets
0No countries in this category.
Export Statistics
155 countries · 10 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
Unit XI – Oncology APIs
Jadcherla, Telangana
- Blocks
- 4
- Area
- 62,000 sq.ft
Classification
ISO 7 Clean RoomSterile Block
Manufacturing Site
Unit V – Cardiovascular APIs
Bachupally, Hyderabad
- Blocks
- 5
- Area
- 85,000 sq.ft
Classification
ISO 8 Clean Room
Supporting Infrastructure
R&D, QC, Warehousing & Stability
- Dedicated R&D centre with 600+ scientists
- USFDA inspected QC laboratories
- Controlled-temperature warehousing
- Pilot plant for tech-transfer
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
- 5 kg pilot · 100 kg commercial
- Lead time
- 4 – 8 weeks (depending on scale)
- Contract manufacturing
- Supported
- Long-term supply
- Multi-year contracts
Packaging Options
Standard packaging formats
- 25 kg HDPE drumsValidated packaging meeting export-grade requirements.
- Double polyethylene linerValidated packaging meeting export-grade requirements.
- 50 kg fibre drumsValidated packaging meeting export-grade requirements.
Certifications & Documents
Downloadable documentation pack
Secure document access. Restricted documents require an NDA submitted through the RFQ form.
- GMPDownloadWHO GMP Certificate2026 Renewal · 320 KB
- ISODownloadISO 9001:2015 CertificateActive · 210 KB
- DMFRequestUS DMF Acknowledgement (consolidated)NDAActive · 640 KB
- CEPDownloadEDQM CEP IndexActive · 480 KB
- FDARequestUSFDA Establishment Inspection ReportNDA2026 · 1.2 MB
- TDSDownloadProduct Catalog 2026v8.2 · 3.8 MB
RFQ / Supplier Contact
Contact Aurobindo Pharma Ltd
Send a structured inquiry routed through APINEXA's coordination team — confidential, compliance-pre-checked, audit-grade. Typical response in 6 hours.