Perindopril API Manufacturer in Maharashtra, India

WHO Essential Medicine NRTI for HIV-1 Antiretroviral Combination Therapy

Perindopril API Manufacturer and Bulk Supplier in Maharashtra, India – Swapnroop Pharma

Product Specifications

Product Name: Perindopril API
CAS Number: 82834-16-0
Category: Active Pharmaceutical Ingredient
Grade: Perindopril 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%

Perindopril API (CAS No: 82834-16-0)

Nucleoside Reverse Transcriptase Inhibitor (NRTI) for HIV-1 Antiretroviral Therapy

Perindopril (CAS 82834-16-0) is a carbocyclic nucleoside analogue that inhibits HIV-1 reverse transcriptase by competing with the natural substrate deoxyguanosine-5'-triphosphate and incorporating into viral DNA, causing chain termination. It is a cornerstone component of highly active antiretroviral therapy (HAART) and is listed on the WHO Essential Medicines List for HIV treatment in adults and children.

Pharmaceutical companies sourcing Perindopril API require stringent genotoxic impurity control, particularly for carbovir-related process impurities. Perindopril's unique carbocyclic structure demands HPLC purity ≥98% with specific rotation testing and low residual solvent content per ICH Q3C guidelines. Buyers evaluate batch-to-batch consistency in polymorphic form and particle size distribution for tablet compression performance.

Swapnroop Drugs and Pharmaceuticals supplies Perindopril API from our WHO-GMP certified Aurangabad facility with complete IP/BP/USP pharmacopeial compliance. We support ANDA/NDA filing through DMF-referenced documentation, provide fresh monthly batches with 36-month shelf life, and export to 25+ countries with full regulatory dossier support.

Key Features

  • HPLC purity ≥98.0% with full pharmacopeial identification (IR, HPLC, mass spec)
  • Strict genotoxic impurity profiling per ICH M7 guidelines
  • Available as base, hydrochloride, and sulfate salt forms
  • WHO-GMP facility with validated manufacturing process for HAART applications

Applications

  • Combination antiretroviral therapy (HAART) for HIV-1 in adults and paediatrics
  • Fixed-dose combination (FDC) tablets with lamivudine and dolutegravir
  • Oral solution formulation for paediatric HIV treatment programs
  • Generic ARV manufacturing for WHO prequalification programs

Why Choose Swapnroop for Perindopril?

  • WHO-GMP certified Aurangabad facility with audited manufacturing documentation
  • DMF filing support for USFDA, EMA, and CDSCO regulated markets
  • Fresh monthly batch supply with validated 36-month stability data
  • Dedicated account management for ARV procurement programs

Packaging & Supply

Perindopril API is supplied in triple-layer HDPE drums (5 kg, 10 kg, 25 kg) with oxygen absorbers and moisture barrier inner bags to protect the carbocyclic structure during transit. Cold chain logistics (2–8°C) available for export consignments to regulated markets.

Get Bulk Quote

Frequently Asked Questions about Perindopril API

What is the CAS number for Perindopril API?

The CAS number for Perindopril (base form) is 82834-16-0. It is a carbocyclic nucleoside analogue available as base, hydrochloride, and sulfate salt forms from Swapnroop.

What therapeutic class does Perindopril belong to?

Perindopril is a Nucleoside Reverse Transcriptase Inhibitor (NRTI) used as a key component of HAART regimens for HIV-1 treatment in adults and children, listed on the WHO Essential Medicines List.

What purity and grade is Perindopril API available in?

Perindopril API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC purity ≥98.0–102.0%, strict genotoxic impurity profiling per ICH M7, and full pharmacopeial identification testing.

What is the MOQ and lead time for Perindopril 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 available for larger volumes.

Is DMF documentation available for Perindopril API?

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

Perindopril API Bulk Supplier in Aurangabad, Maharashtra, India

Swapnroop Drugs and Pharmaceuticals is a trusted Perindopril 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 Perindopril API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.

Perindopril API Exporter from India – Regulatory Filing Support

As a Perindopril 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 Perindopril API pricing, samples, and sourcing support.