Active Pharmaceutical Ingredient

Pimecrolimus — CAS 137071-32-0

Also known as: Elidel; ASM981

GMP Certified IP / BP / USP Calcineurin Inhibitor / Immunomodulator Aurangabad, India
Pimecrolimus API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Pimecrolimus IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 137071-32-0

Product Overview

Pimecrolimus is a calcineurin inhibitor used as a topical immunomodulator for the treatment of atopic dermatitis (eczema). It inhibits T-cell activation and cytokine release by binding to macrophilin-12, preventing calcineurin activation. Mediocon Inc manufactures Pimecrolimus API at its GMP-certified facility in Aurangabad, Maharashtra, India.

Therapeutic Applications
  • Topical treatment of mild to moderate atopic dermatitis
  • Second-line treatment for eczema in patients unresponsive to corticosteroids
  • Treatment of seborrheic dermatitis and psoriasis
  • Management of facial and intertriginous area eczema

Technical Specifications

ParameterSpecification
CAS Number137071-32-0
Molecular FormulaC43H68N4O11
Molecular Weight810.02 g/mol
GradeIP / BP / USP
CategoryCalcineurin Inhibitor / Immunomodulator
AppearanceWhite to off-white, crystalline powder
SolubilityFreely soluble in methanol, slightly soluble in ethanol, practically insoluble in water
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoPIM/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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