Brexanolone API Manufacturer India

High-Quality Neurosteroid API for Postpartum Depression Injectable Formulations

Quick Answer: Brexanolone API (CAS 516-54-1) is a Neurosteroid (GABA-A Modulator) manufactured and supplied in bulk by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified facility in Maharashtra, India. It is available in Injectable / USP Grade grades with full CoA, MSDS, and DMF documentation, MOQ from 1 kg (sample) to 25 kg+ (commercial), standard lead time 2–4 weeks, and export support to 40+ countries.

Reviewed by Swapnroop Quality Assurance Team · Last updated
Swapnroop Pharma  ·  WHO-GMP Certified  ·  +91 87670 62101
📞 Call Now💬 WhatsApp Quote
Brexanolone API Manufacturer India

Product Specifications

Product Name: Brexanolone API
CAS Number: 516-54-1
Category: Neurosteroid (GABA-A Modulator)
Grade: Injectable / USP Grade
Appearance: White to off-white crystalline powder
Standards: Injectable / USP Grade compliant

Detailed Specifications

ParameterSpecification
AppearanceWhite to off-white crystalline powder
IdentificationIR & HPLC compliant
Assay (HPLC)≥98.0–102.0%
Loss on DryingNMT 1.0%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)2.0 – 4.0
Individual Impurity≤ 0.5%
Total Impurities≤ 1.5%

Get Bulk Quote for Brexanolone API

WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries

💬 WhatsApp Quote✉ Email Enquiry📞 +91 87670 62101

What is Brexanolone API? (CAS No: 516-54-1)

High-Quality Neurosteroid API for Postpartum Depression Injectable Formulations

Brexanolone API is a Neurosteroid (GABA-A Modulator) sold in bulk as an Active Pharmaceutical Ingredient (API), positioned for companies seeking a dependable ingredient source backed by organized quality systems and scalable supply support.

Our manufacturing and supply approach for Brexanolone emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.

Brexanolone is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.

Key Features

  • Documentation support aligned with customer qualification needs
  • Batch-to-batch consistency focused for commercial supply
  • Bulk packaging options designed for safe storage and dispatch
  • Supply planning suited to domestic and export demand

Applications

  • Suitable for formulation development and scale-up studies
  • Used by pharmaceutical buyers seeking consistent raw material supply and documentation coordination
  • Can support commercial procurement, validation batches, and routine production programs
  • Supports manufacturers working on neurosteroid-based injectable CNS formulations.

How to Order Brexanolone API

  1. Send an enquiry via WhatsApp, email, or phone with your required quantity and grade.
  2. Receive product specifications, a CoA sample, and a formal bulk quote from our team.
  3. Confirm order terms, request samples if needed, and finalize documentation (MSDS, DMF, regulatory dossier).
  4. Receive scheduled dispatch with export documentation for domestic or international delivery.

Why Choose Us

  • Consistent commercial communication and responsive quotation support
  • Focus on repeatability, supply continuity, and practical business support
  • Bulk packaging and logistics support for domestic and export dispatch
  • Structured documentation assistance for buyer evaluation

Packaging & Supply

We offer Brexanolone API in pharma-oriented packaging formats including HDPE or fiber drum options with inner protection layers, helping maintain handling quality during storage, shipping, and routine supply movement.

Get Bulk Quote

Related Pharmaceutical APIs

Other APIs available from Swapnroop Pharma

API ManufacturerAbacavirAPI ManufacturerAbirateroneAPI ManufacturerAcalabrutinibAPI ManufacturerAceclofenacAPI ManufacturerParacetamolAPI ManufacturerAcyclovir

Frequently Asked Questions about Brexanolone API

What is Brexanolone API used for?

Brexanolone API is a Neurosteroid (GABA-A Modulator) supplied in bulk to licensed pharmaceutical manufacturers, who use it as the active ingredient to formulate finished dosage forms, subject to regulatory approval in the destination market.

What is the CAS number for Brexanolone API?

The CAS number for Brexanolone API is 516-54-1. It is an Active Pharmaceutical Ingredient (API) manufactured by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified company in Maharashtra, India.

What pharmacopeial grades is Brexanolone API available in?

Brexanolone API is available in Injectable / USP Grade pharmacopeial grades with HPLC purity ≥98.0–102.0%. All batches come with full CoA, MSDS, and pharmacopeial identification testing.

What is the MOQ and lead time for Brexanolone API?

Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Expedited supply is available for larger volumes.

Is DMF documentation available for Brexanolone API?

Yes, Swapnroop provides full DMF-grade documentation for Brexanolone API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.

Does Swapnroop export Brexanolone API internationally?

Yes, Swapnroop exports Brexanolone API to 40+ countries including the USA, UK, UAE, Germany, Australia, South Africa, Nigeria, Kenya, Brazil, and Southeast Asian markets. We provide full export documentation and regulatory support.

Brexanolone API Bulk Supplier in India

For companies evaluating Brexanolone API manufacturer options in India, this page offers a clear overview of the product profile, quality approach, and supply readiness.

Brexanolone API Manufacturer for Commercial Sourcing

Our team works with buyers who need Brexanolone API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.