Lutetium Lu 177 Dotatate API Manufacturer India

High-Purity Peptide Receptor Radionuclide Therapy Agent for Neuroendocrine Tumour Formulations

Quick Answer: Lutetium Lu 177 Dotatate API (CAS 1310096-19-3) is a Radiopharmaceutical (Peptide Receptor Radionuclide) manufactured and supplied in bulk by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified facility in Maharashtra, India. It is available in Radiopharmaceutical / Injectable Grade grades with full CoA, MSDS, and DMF documentation, MOQ from 1 kg (sample) to 25 kg+ (commercial), standard lead time 2–4 weeks, and export support to 40+ countries.

Reviewed by Swapnroop Quality Assurance Team · Last updated
Swapnroop Pharma  ·  WHO-GMP Certified  ·  +91 87670 62101
📞 Call Now💬 WhatsApp Quote
Lutetium Lu 177 Dotatate API Manufacturer India

Product Specifications

Product Name: Lutetium Lu 177 Dotatate API
CAS Number: 1310096-19-3
Category: Radiopharmaceutical (Peptide Receptor Radionuclide)
Grade: Radiopharmaceutical / Injectable Grade
Appearance: Clear, colourless to slightly yellow solution
Standards: Radiopharmaceutical / Injectable Grade compliant

Detailed Specifications

ParameterSpecification
AppearanceClear, colourless to slightly yellow solution
IdentificationPeptide Map / HPLC compliant
Purity (SE-HPLC)≥98.0%
Protein ContentAs per label claim ± 10%
EndotoxinNMT 0.5 EU/mg
BioburdenWithin compendial limits
pHAs per product specification
Host Cell ProteinWithin qualified limits
Aggregates/FragmentsWithin compendial limits

Get Bulk Quote for Lutetium Lu 177 Dotatate API

WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries

💬 WhatsApp Quote✉ Email Enquiry📞 +91 87670 62101

What is Lutetium Lu 177 Dotatate API? (CAS No: 1310096-19-3)

High-Purity Peptide Receptor Radionuclide Therapy Agent for Neuroendocrine Tumour Formulations

Lutetium Lu 177 Dotatate API is a Radiopharmaceutical (Peptide Receptor Radionuclide) sold in bulk as an Active Pharmaceutical Ingredient (API), positioned for companies seeking a dependable ingredient source backed by organized quality systems and scalable supply support.

Our manufacturing and supply approach for Lutetium Lu 177 Dotatate emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.

Lutetium Lu 177 Dotatate is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.

Key Features

  • Documentation support aligned with customer qualification needs
  • Batch-to-batch consistency focused for commercial supply
  • Bulk packaging options designed for safe storage and dispatch
  • Supply planning suited to domestic and export demand

Applications

  • Suitable for formulation development and scale-up studies
  • Used by pharmaceutical buyers seeking consistent raw material supply and documentation coordination
  • Can support commercial procurement, validation batches, and routine production programs
  • Supports manufacturers and radiopharmacies working on peptide receptor radionuclide therapy formulations under applicable radioactive-material licensing.

How to Order Lutetium Lu 177 Dotatate API

  1. Send an enquiry via WhatsApp, email, or phone with your required quantity and grade.
  2. Receive product specifications, a CoA sample, and a formal bulk quote from our team.
  3. Confirm order terms, request samples if needed, and finalize documentation (MSDS, DMF, regulatory dossier).
  4. Receive scheduled dispatch with export documentation for domestic or international delivery.

Why Choose Us

  • Consistent commercial communication and responsive quotation support
  • Focus on repeatability, supply continuity, and practical business support
  • Bulk packaging and logistics support for domestic and export dispatch
  • Structured documentation assistance for buyer evaluation

Packaging & Supply

We offer Lutetium Lu 177 Dotatate in pharma-oriented cold-chain packaging formats including single-use vials with validated insulated shippers and temperature monitoring, helping maintain product integrity during storage, shipping, and routine cold-chain supply movement.

Get Bulk Quote

Related Pharmaceutical APIs

Other APIs available from Swapnroop Pharma

API ManufacturerAbacavirAPI ManufacturerAbirateroneAPI ManufacturerAcalabrutinibAPI ManufacturerAceclofenacAPI ManufacturerParacetamolAPI ManufacturerAcyclovir

Frequently Asked Questions about Lutetium Lu 177 Dotatate API

What is Lutetium Lu 177 Dotatate API used for?

Lutetium Lu 177 Dotatate API is a Radiopharmaceutical (Peptide Receptor Radionuclide) supplied in bulk to licensed pharmaceutical manufacturers, who use it as the active ingredient to formulate finished dosage forms, subject to regulatory approval in the destination market.

What is the CAS number for Lutetium Lu 177 Dotatate API?

The CAS number for Lutetium Lu 177 Dotatate API is 1310096-19-3. It is an Active Pharmaceutical Ingredient (API) manufactured by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified company in Maharashtra, India.

What pharmacopeial grades is Lutetium Lu 177 Dotatate API available in?

Lutetium Lu 177 Dotatate API is available in Radiopharmaceutical / Injectable Grade pharmacopeial grades with HPLC purity ≥98.0%. All batches come with full CoA, MSDS, and pharmacopeial identification testing.

What is the MOQ and lead time for Lutetium Lu 177 Dotatate API?

Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Expedited supply is available for larger volumes.

Is DMF documentation available for Lutetium Lu 177 Dotatate API?

Yes, Swapnroop provides full DMF-grade documentation for Lutetium Lu 177 Dotatate API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.

Does Swapnroop export Lutetium Lu 177 Dotatate API internationally?

Yes, Swapnroop exports Lutetium Lu 177 Dotatate API to 40+ countries including the USA, UK, UAE, Germany, Australia, South Africa, Nigeria, Kenya, Brazil, and Southeast Asian markets. We provide full export documentation and regulatory support.

Lutetium Lu 177 Dotatate API Bulk Supplier in India

For companies evaluating Lutetium Lu 177 Dotatate API manufacturer options in India, this page offers a clear overview of the product profile, quality approach, and supply readiness.

Lutetium Lu 177 Dotatate API Manufacturer for Commercial Sourcing

Our team works with buyers who need Lutetium Lu 177 Dotatate API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.