Non-opioid centrally acting analgesic API

Flupirtine Maleate API

Name: Flupirtine Maleate API
Brand: Apex Pharma API

CAS 75507-68-5 C15H17FN4O2·C4H4O4 M.W. 420.40

Manufactured in-house at our Saykha GIDC plant in USP, EP and in-house specification grades — supplied with batch CoA as standard and DMF support for regulated filings.

Flupirtine Maleate API — bulk active pharmaceutical ingredient

Overview

Flupirtine maleate is a non-opioid, centrally acting analgesic used in formulations for the management of acute pain where an opioid mechanism is not wanted. It is a specialised molecule with a limited supplier base, which makes a documented, reproducible impurity profile and dependable delivery the deciding factors for formulators sourcing it.

Apex Pharma API has manufactured Flupirtine Maleate since 2015 on a single established route, so the impurity profile stays consistent between campaigns. You buy directly from the plant that makes it, with the QC team that released the batch available to answer your questions.

Specifications

Product name	Flupirtine Maleate (bulk active pharmaceutical ingredient)
CAS number	75507-68-5
Molecular formula	C15H17FN4O2·C4H4O4
Molecular weight	420.40
Grades available	USP · EP · In-house specification
Appearance	Yellow to greenish-yellow crystalline powder
Assay	Per applicable pharmacopoeial monograph (grade-specific)
Packaging	1 kg / 5 kg / 25 kg — HDPE drum with double LDPE liner; other configurations on request
Storage	Store in a tightly closed container, protected from light and moisture, at controlled room temperature
Supply capacity	Trial quantities to repeat commercial volumes — confirmed at quotation

Full specification sheet and method of analysis issued with the quotation. Packaging and storage confirmed per destination market.

Applications

Non-opioid analgesic formulations

Oral solid dosage forms for the management of acute pain without opioid mechanisms.

Musculoskeletal pain products

Tablets and capsules used where a centrally acting, non-opioid analgesic is indicated.

Modified-release development

Reference-grade material for formulators developing controlled-release presentations.

Combination products

Fixed-dose combinations where a consistent impurity profile is critical across batches.

Regulatory & documentation

Everything your QA and regulatory teams need to open a file on us, issued at quotation stage rather than after the order.

GMP MANUFACTUREDDMF ON REQUESTCoA PER BATCHMSDSSPECIFICATION SHEETMETHOD OF ANALYSIS

See the full quality & certifications detail →

Flupirtine Maleate API — buyer questions

What is the MOQ for Flupirtine Maleate API?

Supply starts at trial quantities. The commercial minimum is agreed against your grade and packaging requirement at quotation and is not a single fixed figure.

Will a sample come with a CoA?

Yes. Samples are issued together with the batch CoA so your QC team can verify against your specification before committing to a purchase order.

How quickly can you despatch?

Stocked grades move within days of order confirmation. Larger campaign quantities are scheduled and a firm date is confirmed before you commit.

Is documentation available for regulated filings?

DMF support and open-part documentation are provided on request. Share the target market and we will confirm what documentation we can make available.