About Us

Contract Pharmacal Corporation India Pvt. Ltd. (CPC India) was founded in 2013 and is a wholly owned subsidiary of Contract Pharmacal Corp. USA. CPC India’s development facility is home to 20 highly skilled scientists engaged in Generic Products development. CPC India is on mission to provide innovative yet cost effective patient-centric products around the world.


  • Intellectual Property Evaluation and Product Identification
  • Formulation Research and Development
  • Analytical Research and Development
  • Technology Transfer
  • Dossier Compilation and Regulatory support
  • Stability studies
  • Bioequivalence and Clinical Services
  • Quality Services

Intellectual Property Evaluation and Product Identification

  • Patent evaluation
  • Strategy design and Product Development
  • Prof of concept studies
Man smiling warmly

Formulation Research and Development

CPC India’s product development services are designed to quickly deliver robust formulations to support our customer’s commercial timelines. We carry out product development using Quality-By-Design tools like Design of Experiment (DOE) along with risk assessment with desired Critical Quality Attributes (CQA). Desired product attributes are identified, and prototype formulations are developed to meet the desired product attributes. Critical process parameters (CPP) are identified, and process optimization studies are carried out based on Quality by Design (QbD) principles.

CPC can develop

Tablets – Immediate release, Delayed release, Sustained release, Film coated, Bilayer

Hard Gelatin Capsules: Granules in Capsules, Tablets in Capsules, Pellets in Capsules

Multiple Unit Particulate Systems (MUPS)

Powder: Powder for Oral Solution/Suspension

Formulation Technologies

  • Dry blending
  • High shear granulation
  • Fluid bed granulation
  • Dry granulation (Roller compaction)
  • Wurster coating
  • Spray drying


  • High Shear Mixer Granulator (2 Liter – 50 Liter)
  • Fluid Bed dryer (0.2 kg – 5kg)
  • Fluid bed process (Top spray and Wurster)
  • Milling machine (C0-mill, Communiting mill)
  • V-Blender (2 Liter – 200 Liter)
  • Tablet press with Bi-layer capability
  • Capsule filling machine
  • Auto coater (0.5 kg – 4 kg)
  • Blister packing (PVC, PVDC and Alu Blister)
  • Induction sealing machine
  • IPQC Instruments

Analytical Research and Development

CPC India’s cost-effective Analytical Research and Development team is efficient, accurate and robust. Analytical research and development lab is a state-of-art laboratory with all modern instruments to carry out the method development and validation required for formulation development.

scientists on computers working

Analytical Expertise

  • Analytical Method Development and Validation by
  • Residual solvent Analysis
  • Dissolution studies (Comparative dissolution studies, multimedia, and DDR)
  • Elemental Analysis
  • Particle size analysis
  • Identification and qualification by UV and FTIR
  • Stability studies as per ICH
  • Reverse engineering study


  • HPLC/UPLC with PDA Detector
  • GC-MS
  • GC with Head Space
  • Malvern Particle size analyzer
  • USP Type I and II Dissolution apparatus with auto sampler
  • FT-IR
  • UV-Visible spectrophotometer
  • Karl-Fischer Titrator
  • Auto titrator
  • Stability chamber as per ICH storage conditions
  • 2°C to 8°C refrigerator
Gansons machinery

Technology Transfer

CPC India routinely carries out transfer of methods and technology to various global manufacturing sites for scale-up and commercializing of pharmaceutical dosage forms like oral solids and liquids. While providing seamless transfer of methods and technology, CPC implements all the necessary controls, with the use of systematic protocol-based project management, including analytical support and an independent stability monitoring group to complement the needs.

Dossier Compilation and Regulatory support

At CPC India, our regulatory team has a sound understanding of global regulatory requirements. Our in-house team of regulatory experts facilitates meeting challenging timelines, and our processes are designed to provide cost effective study management solutions towards regulatory authorizations.

We provide the following regulatory services:
  • Strategies to obtain effective and efficient pathway towards required regulatory approvals
  • Submit dossiers to US FDA and other global authorities for approvals
  • Address deficiency questions and generation of data during registration phase
  • Product Life cycle management

Stability studies

CPC India offers release testing, stability testing, and stability storage in a state-of-the-art facility with comprehensive expertise in the areas of pharmaceutical products. With more than 10,000-liter samples on storage, CPC has the capacity to handle all pharmaceutical Rx, OTC, and dietary supplement stability projects. Our stability services focus on the delivery of timely and reliable data to support every stage of the product development lifecycle. Our stability studies support all phases of drug development.

Bioequivalence and Clinical services

  • Bioequivalence site Identification
  • Protocol Design and study monitoring
  • IVIVC studies
  • BE failure investigation and formulation strategy
  • BCS based bio-waiver
  • Biorelevant in-vitro dissolution development
  • Bioequivalence strategies for BCS class II and IV drugs

Quality Services

  • Conducting vendor Audit for API and Excipients
  • Review of development report, protocols, specifications, analytical method validation documents
  • Conducting vendor Audit for API and Excipients
  • Review of development report, protocols, specifications, analytical method validation documents