Our core_

Services

Formulation
Development Services

Formulation.
Tech Transfer.

Facility_

SUSHEN’s state-of-the-art R&D facility offers FnD services, to our International valued clients.

  • 43,000 Sq. Ft. Area & 38,000 Sq. Ft. of constructed area
  • WHO-GMP certified, DSIR-Govt of India approved R&D facility and in process for US FDA and UL MHRA approval
  • Formulation Development set-up
  • Facility includes UPLC/HPLC, GC, FTIR, AAS, Walk-in Stability Chambers etc
  • Stability Studies Management
  • Total Validation support
  • Knowledge Management Sharing
  • Pilot batch as well as Scale-up facility

At SUSHEN, we believe that our real capital is a dedicated team of highly qualified team of scientists, pharmacists and engineers having in-depth knowledge and vast experience of project management as well as Formulation and Development (FnD) which does

  • Contract Research Activities
  • Formulation & Development (FnD)

Strengthening Product Portfolio_

  • SUSHEN delivers a broad range of drug formulation and development services for molecules in a variety of dosage forms such as–Tablet (IR, SR, MR, Mouth Dissolving, Sub Lingual, Chewable, Dispersible, etc.) Capsules and Pallets
  • GMP manufacturing facility for Clinical Trial batches
  • Formulation Development with Pilot BE batch and Tech Transfer to the manufacturing site
  • Development of specification and method of Analysis (MOA)
  • Separation and Purification of Impurities
  • Method Development, Optimization and Validation
  • Organizing BA/BE Studies
  • Preparation of CTD / ANDA Dossiers
  • Microbiology studies
  • Endotoxin Testing
  • Identification of microbes up to genus and species level
  • Physiochemical characteristics of the drug
  • Solubility characteristics of the drug
  • Drug-Excipient Compatibility
  • Analytical method development & validation
  • Stability studies
  • Tablets : Immediate Release(IR), Modified Release(MR), Controlled Release(CR), Mouth-Dissolving, Sub-lingual, Enteric coated, Chewable etc.
  • Capsules
  • Pellets
  • Sample storage at various conditions
  • Continuous recording of storage parameters with 21 CFR compliance
  • Timely retrieval of sample & Analysis
  • Preparation of final report and documentation for submission
  • Providing rental storage facility
  • Project design Equipment selection
  • Scale - up Studies
  • Process validation

Validation and Support activities_

  • Validation Master Plan (VMP)
  • Qualification protocols like DQ, IQ, OQ, PQ.
  • Validation protocol for utility systems,processes, cleaning, analytical method with validation summary report
  • Actual qualification and Validation support for equipment, system and processes
  • Training

Pharmaceutical Project
Management Services

Pharma Project.
Turnkey Solutions.

The company provides you with critical understanding of the global pharmaceutical requirements for production and marketing of various formulations. SUSHEN’s range of services covers right from conceptualization and designing of a new plant to its construction, setting up manufacturing facilities to its commissioning.

The company’s expertise also includes extension and expansion of an existing plant with all modern and regulatory aspects. In short, we provide a complete turnkey solution for the pharmaceutical industry.

Designing of Plant
(as per WHO-GMP/ USFDA / UK MHRA)_

  • Site master planning
  • Conceptualization & capacity balancing
  • Equipment sizing & selection
  • Architectural design services
  • Civil and structural work
  • Heating Ventilation and air conditioning (HVAC) engineering
  • Mechanical and piping engineering
  • Electrical engineering

Equipment and
processing specifications_

  • Expertise in procurement, installation and qualification for requirement & machineries
  • Provide supply of complete production equipment as well HVAC and cleaning room panel system
  • Preparations of these equipment and system qualifications protocol such as URS, DQ, IQ, OQ, PQ

Engineering Services_

  • Inception to Execution
  • Commissioning of Plant
  • Mock Audit
  • Inspection for Gap Analysis
  • Documentation (SOPs)

We endeavor to offer the best price in the market, with the objective of building a long-term relationship with our clients.

Cost and time overruns lead to losses for clients. Hence, we lay great emphasis on timely completion of the projects, which leads to customer satisfaction and retention.