Oncology & Anticancer

Peg L-AsparaginaseThird Party Manufacturing in India

Looking to get Peg L-Asparaginase manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
9015-68-3
Drug Class
Asparagine depleting enzyme
Molecular Weight
Combination product
Grade Standards
IP, USP
Therapeutic Category
Oncology & Anticancer
MOQ
500 vials per batch
Dosage Forms
Lyophilized Injection

Mechanism of Action

Peg L-Asparaginase works by catalyzing the cleavage of systemic L-asparagine into aspartic acid and ammonia. Leukemic cells lack the enzyme asparagine synthetase and rely on circulating exogenous L-asparagine for protein synthesis, leading to cellular starvation and death when depleted. Unlike native bacterial asparaginase, the covalent attachment of polyethylene glycol blocks immunogenic epitopes, extending the plasma half-life and lowering the frequency of hypersensitivity reactions. It is highly effective and well-tolerated in pediatric and adult leukemia protocols.

Therapeutic Uses & Indications

Therapeutic Uses

  • Acute Lymphoblastic Leukemia: Integral component of multi-agent chemotherapy regimens for first-line treatment.
  • NK/T-cell Lymphoma: Used as part of specialized therapeutic combinations for aggressive extranodal variants.

Why Manufacturers Choose Peg L-Asparaginase

This pegylated biological entity presents unique manufacturing complexities that deter general formulation companies. Peg L-Asparaginase third party manufacturing in India requires precise macromolecular handling and specialized lyophilization capabilities to retain enzymatic activity under CAS 9015-68-3. Our partner network features cold-chain logistics integrated directly into operational setups, where our production facilities are WHO-GMP certified for sterile biological processing. We provide distributors with a reliable procurement route for this high-value asset, ensuring compliance with strict international biological regulations.

Dosage Forms We Manufacture

Lyophilized Injection
3750 IU

Frequently Asked Questions

What is the minimum order quantity for Peg L-Asparaginase?
Minimum order quantity for Peg L-Asparaginase is 500 vials per batch. Please contact us for bulk pricing and custom quantities.
What dosage forms of Peg L-Asparaginase can you manufacture?
We manufacture Peg L-Asparaginase as: Lyophilized Injection (3750 IU).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Peg L-Asparaginase for export?
Yes. We provide export-ready Peg L-Asparaginase formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Peg L-Asparaginase?
We manufacture Peg L-Asparaginase to IP, USP pharmacopoeial standards.
Third Party Manufacturing

Get Peg L-Asparaginase made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • MOQ from 500 vials per batch
Get a Manufacturing QuoteWhatsApp Us Now

+91 9689237122 · replies within hours

Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

Sterile lyophilization vials with specialized low-temperature seals. Packaging customized to client brand guidelines.

Start Manufacturing Peg L-Asparaginase Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Peg L-Asparaginase across all dosage forms. PCD franchise and export orders welcome.

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