Ambenonium Chloride API Manufacturer in Maharashtra, India

Active Pharmaceutical Ingredient – Manufacturer and Bulk Supplier in Maharashtra for Pharmaceutical Formulation Development And Manufacture

Swapnroop Pharma  ·  WHO-GMP Certified  ·  +91 87670 62101
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Ambenonium Chloride API Manufacturer and Bulk Supplier in Maharashtra, India – Swapnroop Pharma

Product Specifications

Product Name: Ambenonium Chloride API
CAS Number: 78-53-5
Category: Active Pharmaceutical Ingredient
Grade: IP / BP / EP / USP
Appearance: White to off-white crystalline powder
Standards: IP / BP / EP / USP 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%

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

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Ambenonium Chloride API (CAS No: 78-53-5)

WHO-GMP Certified Ambenonium Chloride API Manufacturer in Maharashtra, India

Ambenonium Chloride API (CAS 78-53-5) is an Active Pharmaceutical Ingredient used in the formulation of prescription and/or over-the-counter pharmaceutical products. manufactures and supplies Ambenonium Chloride API with pharmacopeial compliance (IP/BP/EP/USP as applicable) from our WHO-GMP certified facility in Aurangabad (MIDC Shendra), Maharashtra — one of India's premier pharmaceutical manufacturing zones with robust regulatory infrastructure.

Pharmaceutical formulation companies sourcing Ambenonium Chloride API require consistent polymorphic or salt form characterisation, batch-to-batch HPLC purity ≥98% (or per specific pharmacopeial monograph), validated residual solvent control per ICH Q3C, and full impurity profiling against pharmacopeial limits. Our quality control laboratory performs complete pharmacopeial testing with USP/EP/IP validated analytical methods before every batch release.

Swapnroop's Ambenonium Chloride API supply is backed by WHO-GMP certified manufacturing, a qualified vendor documentation package (CoA, MSDS, Certificate of Origin, stability data), and dedicated technical support for domestic formulation companies and international export customers. We maintain inventory for rapid order fulfilment across 25+ countries served from our Aurangabad facility.

Key Features

  • HPLC purity ≥98.0% (or per specific IP/BP/USP monograph for Ambenonium Chloride)
  • Complete pharmacopeial testing: identification, assay, impurities, LOD, residue on ignition
  • Residual solvent control per ICH Q3C with validated GC/headspace methodology
  • WHO-GMP certified batch with full documentation package for regulatory submissions

Applications

  • Pharmaceutical tablet and capsule formulation development using Ambenonium Chloride API
  • Injectable or parenteral formulation programs where Ambenonium Chloride is indicated
  • R&D, pilot batch, and commercial manufacturing for domestic and regulated markets
  • Fixed-dose combination (FDC) drug product development programs

Why Choose Swapnroop for Ambenonium Chloride?

  • WHO-GMP certified Aurangabad facility with CDSCO-approved manufacturing unit
  • Complete qualified vendor documentation: CoA, MSDS, CoO, stability reports
  • Export capability to 25+ countries with pharmacopeial-grade API
  • Responsive technical support and dedicated account management for long-term buyers

Packaging & Supply

Ambenonium Chloride API is supplied in double-polyethylene-lined HDPE drums or fiber drums (25 kg net) with desiccant and nitrogen head-space. Smaller quantities (1 kg, 5 kg) in sealed HDPE jars for R&D programs. All packaging labelled with batch, grade, and pharmacopeial standard.

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Frequently Asked Questions about Ambenonium Chloride API

What is the CAS number for Ambenonium Chloride API?

The CAS number for Ambenonium Chloride is 78-53-5. It is a Active Pharmaceutical Ingredient used in pharmaceutical pharmaceutical formulation development and manufacture.

What therapeutic class does Ambenonium Chloride belong to?

Ambenonium Chloride is classified as a Active Pharmaceutical Ingredient. It is used in pharmaceutical formulation development and manufacture and is an established API in both domestic Indian and international pharmaceutical markets.

What grades and purity specifications are available for Ambenonium Chloride API?

Ambenonium Chloride API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC purity ≥98.0–102.0%, complete related substances profiling, and residual solvent analysis per ICH Q3C guidelines.

What is the minimum order quantity and lead time for Ambenonium Chloride 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. Larger volumes may be available from existing stock.

Is DMF-grade documentation available for Ambenonium Chloride API?

Yes, Swapnroop provides complete DMF-grade documentation for Ambenonium Chloride API including Certificate of Analysis (CoA), MSDS, impurity profile, residual solvent certificate, and regulatory filing support for USFDA, EMA, and CDSCO submissions.

Ambenonium Chloride API Bulk Supplier in Aurangabad, Maharashtra, India

Swapnroop Drugs and Pharmaceuticals is a trusted Ambenonium Chloride API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Ambenonium Chloride API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.

Ambenonium Chloride API Exporter from India – Regulatory Filing Support

As a Ambenonium Chloride API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Ambenonium Chloride API pricing, samples, and sourcing support.