Manufacturing Facility

Mac-Chem API facility is located at Boisar, 100 kms away from the financial capital of India - Mumbai. This plant, spread over 3976 occupies 1750 constructed area which includes Administrative Block, 3 Production Blocks (For General API, Oncology API and Lyophilized Bulk Sterile), Quality Control, Quality Assurance, Warehouse and Utilities. Mac-Chem has established world class infrastructure for manufacturing APIs complying with the requirements of regulated and semi-regulated markets.

Our plant comprises of followings:
  • 8 Stainless Steel Reactors of 500 L, 1000 L and 2500 L Capacities.
  • 2 Lyophilizers of 140 L and 400 L Capacities.
  • 1 Dry Heat Sterilizer of 500 L Capacity.
  • Different type of Dryers (ANFD and VTD).
  • 6 Glass Lined Reactors of 63 L, 250 L, 500 L, 1000 L and 1600 L Capacities.
  • 2 Steam Sterilizer of 430 L and 810 L Capacities.
  • 8 Stainless steel Isolators.
  • Multi Mill, Shifter, Blender and Filters.
Our Infrastructure
  • State-of-the art Cat III & IV Containment Facility.
  • Glove Box technology for highly potent cytotoxic pharmaceutical substances.
  • Powder processing with minimum OEL limit.
  • Lyophilisation Technology.
  • Modern QA, QC, Microbiological and PD Lab supported with high-tech equipment.
  • Capabilities for gram level to kilo level.
  • Fully automated electronically controlled operating system as per GAMP (Good Automated Manufacturing Practice).
  • Effluent Treatment Plant (ETP) with a capacity of 10,000 litres per day.
  • Total reaction capacities – 1900 litres.
  • Annual Production Capacity –
    • Oncology API : 15000 Kgs.
    • Bulk Sterile     : 15000 Kgs.
    • General API    : 10000 Kgs.
Technical Expertise
  • A team of 41 scientists (both in Synthesis and Analytical) working round the clock at our API - R&D center.
  • Other support staff include Regulatory and Project Management.
  • Our Analytical team comprises scientists and lab assistants with experience of handling all the latest analytical equipment. We also have a specialized team with vast experience in method development and validations, which supports the robustness of product specifications and compliances as per the requirement.
  • Mac-Chem ensures adherence and compliance with all the applicable cGMP and ICH guidelines and regulatory requirements.
  • Our Regulatory team act as a liaison with regulatory agencies and provide expertise & regulatory intelligence in translating their requirements into practical workable plans. They also evaluate products and their ROS in line with regulatory guidelines and prepare valid DMF for submissions.
Key Strengths
Oncology APIs
General and Bulk Sterile APIs
Expertise in Lyophilisation
Strong R&D
Expert Regulatory Team & In-house IP cell
Strict adherence to EHS program
Safety Health and Enviroment Policy Download PDF
Quality Policy
  • Mac-Chem Group is committed in manufacturing and supplying the APIs to meet the established requirements of customers and applicable statutory and regulatory requirements.
  • We will strive to enhance satisfaction of our customers by effective application of process approach to improve each of our processes.
  • We will effectively involve all our employees and vendors in our effort to exceed customer expectations.
  • Various training methodologies are used for imparting learning such as instructor led training, experiential learning, simulation based learning, activity oriented learning, e-learning , case study based approach etc.
  • Our induction and handholding itself starts with a structured onboarding to acclimatize the new employees to our products/ processes/ culture and ensure a smooth transition into the organization.
  • Other than formal and structured training interventions, our leaders and managers continuously provide informal mentoring to their team members to groom them for growth and larger roles.