Active Pharmaceutical Ingredient

Lofepramine Hydrochloride API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 26786-32-3 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Lofepramine Hydrochloride API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Lofepramine Hydrochloride API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 26786-32-3 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Lofepramine Hydrochloride is a pharmaceutical active ingredient belonging to the tricyclic antidepressant (TCA) class and is the hydrochloride salt of lofepramine. Lofepramine is structurally related to the dibenzazepine group of tricyclic antidepressants and is recognized for its pharmacological activity on monoamine neurotransmitter systems, particularly through inhibition of the reuptake of norepinephrine and other neurotransmitters involved in neuronal signaling. Lofepramine is also metabolized to desipramine, an active metabolite that contributes to its pharmacological effects.

Chemically, Lofepramine Hydrochloride is identified as 1-(4-chlorophenyl)-2-[3-(5,6-dihydrobenzo[b][1]benzazepin-11-yl)propyl-methylamino]ethanone hydrochloride. The compound has the molecular formula C₂₆H₂₈Cl₂N₂O, a molecular weight of approximately 455.42–455.4 g/mol, and CAS No. 26786-32-3. The hydrochloride salt is the commercially relevant pharmaceutical form, while the corresponding Lofepramine free base is separately identified by CAS 23047-25-8 and has a molecular weight of approximately 419.0 g/mol.

Lofepramine Hydrochloride has been associated with the treatment and research of depressive disorders and is recognized as a tricyclic antidepressant pharmaceutical compound. Its pharmacological profile is related to modulation of monoaminergic neurotransmission, making the active ingredient relevant to pharmaceutical formulation development and research involving antidepressant therapies. The compound has also been used as a pharmaceutical reference substance for analytical and quality-control purposes.

MEDIOCON INC supplies Lofepramine Hydrochloride for pharmaceutical, formulation-development, analytical, research, and applicable bulk API requirements, subject to product availability, applicable specifications, regulatory requirements, and supporting quality documentation. MEDIOCON INC can support customers requiring Lofepramine Hydrochloride for pharmaceutical development, analytical testing, research programs, and API sourcing, with the exact grade, assay, impurity profile, packaging, storage requirements, and documentation to be confirmed against the applicable Certificate of Analysis and product specification.

Lofepramine Hydrochloride is reported as a powder and commercial reference information reports it as soluble in DMSO and insoluble in water. A commercial reference source reports a melting-point range of approximately 152–154°C. These physical-property values should be regarded as reference information rather than automatically treated as MEDIOCON release specifications.

For pharmaceutical procurement and database management, it is important to distinguish Lofepramine Hydrochloride from Lofepramine free base. Lofepramine Hydrochloride is CAS 26786-32-3, whereas Lofepramine free base is CAS 23047-25-8. The two forms have different molecular formulas and molecular weights and should therefore be maintained as separate products in the MEDIOCON product database.

Key Applications

  • Pharmaceutical API research
  • Antidepressant formulation development
  • Pharmaceutical R&D
  • Analytical research
  • Quality-control testing
  • Drug-development programs
  • Reference-standard applications
  • Bulk API sourcing

Product Specifications

Product NameLofepramine Hydrochloride API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number26786-32-3
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearancePowder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearancePowder
Melting Point152–154°C

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 Lofepramine Hydrochloride API Manufacturer & Supplier in India | MEDIOCON INC (CAS 26786-32-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Lofepramine Hydrochloride 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 — Lofepramine Hydrochloride API Manufacturer & Supplier in India | MEDIOCON INC

What is Lofepramine Hydrochloride?
Lofepramine Hydrochloride is the hydrochloride salt of lofepramine and a pharmaceutical compound belonging to the tricyclic antidepressant class.
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