Active Pharmaceutical Ingredient

Leuprolide API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 53714-59-9 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Leuprolide API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Leuprolide API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 53714-59-9 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Leuprolide API is a synthetic gonadotropin-releasing hormone (GnRH) analogue and decapeptide pharmaceutical ingredient used to regulate the hypothalamic-pituitary-gonadal axis. It is structurally related to natural GnRH but contains specific amino-acid substitutions that provide enhanced receptor activity and prolonged biological effects compared with endogenous GnRH.

Leuprolide initially stimulates the pituitary GnRH receptors, producing a transient increase in the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). With continued exposure, however, persistent stimulation results in GnRH-receptor desensitization and downregulation, leading to suppression of LH and FSH secretion and a subsequent reduction in gonadal sex-hormone production.

Leuprolide is commonly encountered in pharmaceutical products as Leuprolide Acetate. It is a peptide API relevant to long-acting injectable and other specialized pharmaceutical formulations. The compound is associated with therapeutic applications involving hormone-dependent conditions, including prostate cancer, endometriosis, uterine fibroids and certain reproductive-health indications.

MEDIOCON INC supplies Leuprolide for applicable pharmaceutical manufacturing, peptide formulation development, analytical research, quality-control testing and bulk API requirements, subject to product availability, applicable regulatory requirements and batch-specific documentation.

Key Applications

  • GnRH analogue formulations
  • Hormone-dependent pharmaceutical formulations
  • Oncology formulations
  • Endometriosis-related formulations
  • Uterine fibroid formulations
  • Reproductive endocrinology research
  • Long-acting injectable formulation development
  • Peptide pharmaceutical research
  • Analytical research
  • Bulk API sourcing

Product Specifications

Product NameLeuprolide API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number53714-59-9
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to off-white powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to off-white powder

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Leuprolide API Manufacturer & Supplier in India | MEDIOCON INC (CAS 53714-59-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Leuprolide API Manufacturer & Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Leuprolide API Manufacturer & Supplier in India | MEDIOCON INC

What is Leuprolide?
Leuprolide is a synthetic GnRH analogue and decapeptide pharmaceutical ingredient that regulates gonadotropin secretion through prolonged stimulation followed by suppression of pituitary GnRH receptors.
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