Active Pharmaceutical Ingredient

Clindamycin API Manufacturer & Supplier in India

Also known as: Cleocin (brand)

CAS: 18323-44-9 Lincosamide Antibiotic USP / BP / IP Bulk Supply Available
Clindamycin API Manufacturer India | Mediocon Inc
Clindamycin — Pharmaceutical Grade API

Product Overview

CAS No: 18323-44-9  |  MF: C₁₈H₃₃ClN₂O₅S  |  MW: 424.98 g/mol

Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis at the 50S ribosomal subunit. It is effective against anaerobic bacteria and certain gram-positive organisms. It is used for skin and soft tissue infections, dental infections, bone and joint infections, and as an alternative for penicillin-allergic patients. Mediocon Inc supplies pharmaceutical-grade Clindamycin meeting IP/BP/EP/USP standards.

Key Features

  • Lincosamide antibiotic – excellent anaerobic coverage
  • IP/BP/EP/USP compliant, Assay 99.0% Min.
  • Effective for MRSA-associated skin infections
  • Suitable for oral capsule, topical, and IV formulations

Applications

  • Skin and soft tissue infection treatment
  • Dental abscess and oral infection therapy
  • Bone and joint infection treatment
  • Acne topical gel and solution formulations

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameClindamycin
Also Known AsCleocin (brand)
CAS Number18323-44-9
Molecular FormulaC₁₈H₃₃ClN₂O₅S
Molecular Weight424.98 g/mol
CategoryAntibiotic / Lincosamide
AppearanceWhite to Off-White Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay99.0% Min.
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Related SubstancesComplies
Microbial LimitsComplies with pharmacopoeia
Packing25 kg HDPE drums / as per requirement

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Clindamycin (CAS 18323-44-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Clindamycin is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Clindamycin API

What is the minimum order quantity for Clindamycin API?
Mediocon Inc supplies Clindamycin with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Clindamycin does Mediocon supply?
We supply Clindamycin conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Clindamycin API?
Every shipment of Clindamycin comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Clindamycin bulk orders?
Standard lead time for Clindamycin is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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