Manufacturing Site
API Unit 1 – Bollaram
Bollaram, Hyderabad
- Blocks
- 5
- Area
- 76,000 sq.ft
Classification
ISO 7 Clean Room
Manufacturer ProfileAPINEXA Verified
Dr. Reddy's Laboratories
Dr. Reddy's Laboratories Limited
Globally recognized API & generics manufacturer with deep oncology, cardiovascular and biosimilar capability across USFDA / EMA / PMDA inspected sites.
- Headquarters
- Hyderabad, India
- Established
- 1984 · 42 years
- Company Type
- API Manufacturer · CDMO · Exporter
- Region
- Hyderabad · APAC
Compliance Coverage
USFDAEU GMPWHO GMPPMDADMFISO 14001
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 Jan 2024
Compliance Review
Cleared
Documentation reviewed by APINEXA team
Export Status
Active
Supplying 142 countries
Match Score
94
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 Sep 2027
EU
EU GMP Certification
European Medicines Agency
Valid until Feb 2028
WHO
WHO Good Manufacturing
World Health Organization
PMDA
PMDA Approval
Pharmaceuticals & Medical Devices Agency, Japan
DMF
US Drug Master File
USFDA
ISO
Environmental Management
International Standards Org.
Company Overview
About Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is a leading integrated pharmaceutical company offering portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. The PSAI (Pharmaceutical Services & Active Ingredients) division supplies APIs and steroids to global innovators, generics and CDMO partners across regulated and semi-regulated markets.
Specialization
Oncology APIsSteroids & HormonesCardiovascular APIsCustom SynthesisBiosimilars
Core Strengths
Why buyers choose them
- PSAI vertical integration with finished-dose handoff
- Differentiated steroid & hormone capability
- Custom synthesis & contract manufacturing
- Strong USFDA/EMA inspection track record
Manufacturing Capabilities
Operational strength
Production capacity, technology platforms, and clean-room infrastructure verified at the manufacturer source.
Production Capacity
Large scale · 1,200+ MT/yr
- Batch size
- 10 kg pilot · up to 8,000 kg commercial
- Annual capacity
- 1,200+ MT/year across PSAI sites
- Commercial scale
- Multi-product, multi-site commercial scale
Facility Footprint
9 manufacturing sites
- Plants
- 9
- Manufacturing blocks
- 12 blocks
- Clean-room classes
- ISO 7 Clean Room · Containment Suite
Technology Capabilities
Process technology
- HPAPI handling (OEB 4-5)
- Steroid & hormone capability
- Lyophilization
- Peptide & oligonucleotide research
Product / API Portfolio
168+ 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
USDMFWHO GMPStrong SupplyVery HighView API profile - Oncology
Lenalidomide
CAS 191732-72-6
USDMFEU GMPActive ExportVery HighView API profile - Oncology
Capecitabine
CAS 154361-50-9
USDMFCEPStrong SupplyHighView API profile - Oncology
Imatinib Mesylate
CAS 220127-57-1
USDMFEU GMPActive ExportHighView API profile - Cardiovascular
Rosuvastatin Calcium
CAS 147098-20-2
USDMFCEPStrong SupplyHighView API profile
Regulatory Coverage
Export readiness across regulated markets
Authority-by-authority regulatory standing for major regulated and semi-regulated pharmaceutical markets.
Total Markets
6
Approved
6
Coverage
100%
| Region | Authority | Status |
|---|---|---|
United States | USFDA | Approved |
Europe | EU GMP / EDQM | Approved |
Japan | PMDA | Approved |
Brazil | ANVISA | Approved |
Russia | Roszdravnadzor | Approved |
Mexico | COFEPRIS | Approved |
Export Markets
Active exports across 142 countries
Live supply footprint grouped by market regulatory class — Regulated, Semi-Regulated, and Emerging.
Regulated Markets
4- United States
- United Kingdom
- Germany
- Japan
Semi-Regulated Markets
4- Brazil
- Russia
- Mexico
- South Africa
Emerging Markets
0No countries in this category.
Export Statistics
142 countries · 8 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
API Unit 3 – Pydibhimavaram
Srikakulam, Andhra Pradesh
- Blocks
- 7
- Area
- 112,000 sq.ft
Classification
ISO 7 Clean RoomContainment Suite
Supporting Infrastructure
R&D, QC, Warehousing & Stability
- Integrated R&D centre at Bachupally
- USFDA inspected QC laboratories
- Validated cold-chain warehousing
- Dedicated stability storage chambers
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 · 50 kg commercial
- Lead time
- 3 – 6 weeks
- 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.
Certifications & Documents
Downloadable documentation pack
Secure document access. Restricted documents require an NDA submitted through the RFQ form.
RFQ / Supplier Contact
Contact Dr. Reddy's Laboratories
Send a structured inquiry routed through APINEXA's coordination team — confidential, compliance-pre-checked, audit-grade. Typical response in 4 hours.