Clindamycin Phosphate API Manufacturer in Maharashtra, India

Topical Antibacterial / Keratolytic – Manufacturer and Bulk Supplier in Maharashtra for Acne And Skin Infection Topical Formulations

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

Product Specifications

Product Name: Clindamycin Phosphate API
CAS Number: 24729-96-2
Category: Active Pharmaceutical Ingredient
Grade: Albendazole 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%

Clindamycin Phosphate API (CAS No: 24729-96-2)

WHO-GMP Certified Clindamycin Phosphate API Manufacturer in Maharashtra, India

Clindamycin Phosphate API (CAS 24729-96-2) is an Active Pharmaceutical Ingredient used in the formulation of prescription and/or over-the-counter pharmaceutical products. Swapnroop Drugs and Pharmaceuticals manufactures and supplies Clindamycin Phosphate 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 Clindamycin Phosphate 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 Clindamycin Phosphate 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 Clindamycin Phosphate)
  • 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 Clindamycin Phosphate API
  • Injectable or parenteral formulation programs where Clindamycin Phosphate 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 Clindamycin Phosphate?

  • 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

Clindamycin Phosphate 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.

Get Bulk Quote

Frequently Asked Questions about Clindamycin Phosphate API

What is the CAS number for Clindamycin Phosphate API?

The CAS number for Clindamycin Phosphate is 24729-96-2. It is a Topical Antibacterial / Keratolytic used in pharmaceutical acne and skin infection topical formulations.

What therapeutic class does Clindamycin Phosphate belong to?

Clindamycin Phosphate is classified as a Topical Antibacterial / Keratolytic. It is used in acne and skin infection topical formulations and is an established API in both domestic Indian and international pharmaceutical markets.

What grades and purity specifications are available for Clindamycin Phosphate API?

Clindamycin Phosphate 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 Clindamycin Phosphate 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 Clindamycin Phosphate API?

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

Clindamycin Phosphate API Bulk Supplier in Aurangabad, Maharashtra, India

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

Clindamycin Phosphate API Exporter from India – Regulatory Filing Support

As a Clindamycin Phosphate 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 Clindamycin Phosphate API pricing, samples, and sourcing support.