Company Profile

MOLCLONE LABS PRIVATE LIMITED is a Chennai (Madras) based, Private Limited Company for the manufacture of Active Pharmaceutical Ingredients and Drug Intermediates. The company is managed by technocrats having vast experience in the field of manufacture and marketing of active pharmaceutical ingredients (API) and its intermediates.

The company has a state of the art API manufacturing facility located at 30Kms South of Chennai, capable of synthesizing complex organic molecules and active pharmaceutical ingredients. The manufacturing facility is in conformity with cGMP requirements and WHO GMP certified. Also it meets the requirements of international regulatory bodies too.

Management

Managing Director

Mr. M.U.G.Thirumavalavan is a Post Graduate in Chemistry having more than three decades of experience in the Research & Development of API, Scale up and Project Execution in both Pharmaceutical and Biotechnology. He has serviced in Pharma and Biotech divisions of M/s Southern Petrochemical Corporation Limited (SPIC LTD) at Middle Management position.

He has specialized himself in the synthesis and scale up of varieties Active Pharmaceutical Ingredients right from bench scale to Production batches. Also he is leading our R & D team of Chemists for the process development of new API’s for future business and service to Pharma Industry. Developed the process for the manufacture of Pentosan Polysulphate Sodium, Calcium L-5- Methyltetrahydrofolate(USP) other salts of L-5- Methyltetrahydrofolate, Melarsomine Dihydrochloride.

Director

T.Vikneshkannan has completed his B.E and MBA(Marketing) is taking care of Formulation Marketing in India for our in-house products and takes care of HR requirements in the organization. Being young and new to the organization he is involving himself into various departments and learning about the business.

HEAD – QA/Reg. Affairs

Mr.A.R.Umare Faruk, Head-Quality Assurance, is a Post Graduate in Chemistry, having a experience of more than 2 decades in the field of Pharmaceutical Quality Control, Quality Assurance and Regulatory Affairs of various divisions of SPIC Limited India. He has been well versed in establishing, implementing and maintaining the cGMP requirements of API Plant /Formulated Dosage Forms unit, Training of Personnel, Process, Analytical Methods and cleaning validations, Internal Quality auditing, conducting product quality reviews and maintaining its relevant documentation to ensure the regulatory compliance. He has also been experienced in the preparation and Filing of DMF / Dossiers to meet various regulatory agencies. He is a certified person for release of final products of APIs, Dosage Forms and Intermediates.

Our Facilities

Our clean area for API is designed with HVAC‘s fitted with HEPA filters at the supply, thereby meeting the requirement of class 10,000.

We have been granted the DRUG MANUFACRURING LICENSE FOR THE MANUFACTURE OF DRUG SUBSTANCES IN FORM-25 AND FORM-28 by the State Drugs Control Authorities and also Manufacturing license for Calcium L-5-Methyltetrahydrofolate in Form 28.

Our Quality Control Laboratory is equipped with sophisticated analytical Instruments consisting of UV Spectrophotometer, FTIR Spectrophotometer, TOC analyzer, Gas chromatograph with Head space, HPLC with UV and RI detector along with GPC option, Capillary Zone Electrophoresis and Well equipped Microbiology section for testing of Total count, pathogens and endotoxins.

We have three Stability chambers of 600 Liters each with software support for Accelerated, Intermediate and Real time testing as per ICH guidelines.

We have our own SS water plant with RO and Ion exchange system for Purified Water generation meeting the requirement of IP/BP/USP.

Quality Policy

Our Quality Policy is Defined and Strongly driven by the Following Management Principles.

  • Build a mutually profitable relationship with our customers, ensuring their long-term success, through the understanding of their needs.
  • Achieve our commitments for Quality, Cost and Schedule.
  • Use of best preventive practices at all levels are promoted to ensure reliable Quality Management.
  • Incorporate commitment to Quality in new employee orientation and training.
  • Empower employees to assume responsibility for knowledge and compliance with the Company’s Quality system.
  • Encourage employees to assume responsibility and authority for identifying and reporting deviations from the Quality system