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The SPC Edge

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Infrastructure

Infrastructure

Our Plant is located in the heart of GIDC's Industrial Cluster in Ankleshwar, Gujarat. It is supported by & works simultaneously with our commercial office, research, and development center located in the city of Vadodara Gujarat.


  • Ankleshwar Site:
  • Area:
  • Reaction Capacity:
  • Approval:
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Our plant site at Ankleshwar spreads over an area of 10,000 m sq including warehouses, synthesis blocks, QC/QA laboratories, utility blocks, effluent treatment plants, and administrative offices. A routine inspection at our site is a common occurrence by our customers or designated authorities.


The Ankleshwar plant maintains all required quality and environmental standards and keeps improving them on continous basis. Over the years we have invested in human and capital resources enabling our success, development & growth. We have built an infrastructure to meet cGMP and FDA requirements.

Manufacturing

SPC Lifesciences is a result of our knowledge, backed by state-of-the-art technology, supply chain, & manufacturing capabilities. It is a way to ensure our comprehensive product solutions match the ability to deliver across every complex project.


SPC operates four manufacturing blocks for basic intermediates, advanced intermediates, and strategic products respectively at Ankleshwar. Backed by SPC’s technical team and manufacturing services, this site has a processing capacity of 180 KL equipped with five finishing areas for both solid and liquid handling along with warehouse and effluent treatment facilities to ensure multi-product management with regulatory compliance for intermediate of various scales ranging from 1MT to 50 MT per month.

Quality & Compliances

The key reason for our client's unyielding trust is our top-shelf quality & efficient delivery according to the desired demands and requirements hence every step of our process is underlined by our promise to deliver operational excellence to build quality to specification.


We are committed to quality compliance to ensure a singular quality process that is constantly assessed and refined by our team of experts. Using high-quality chemicals our intermediates and APIs are manufactured to ensure desired efficiency and our ONE QUALITY CONCEPT keeps pushing quality standards even higher while setting new benchmarks.


We adhere to ISO 9001 and ISO 14001, GMP standards controlled by the Quality Assurance Group. Documentation on cGMP guidelines right from raw material receipt, manufacturing to finished products & services.


Further control is established by adherence to cGMP guidelines where all activities starting from receipt of raw materials to dispatch of final products including training, safety, and maintenance are documented and controlled.

ADL

Method development Method Transfer R&D Product Testing & Releasing HPLC / GC Techniques Impurity Isolation Establishment of Reference Standard. Preparation of Specification and MOA.

RA

Regulatory compliance Technical Package Customer Satisfaction Declaration to customer Quality Agreement. DMF preparation. Vendor Questionnaire

QC

Sampling, Testing and Releasing Calibration of instruments. Chromatographic Techniques Wet Chemical Techniques Impurity Tracking Method validation Specification Development. Preparation of Specification and MOA GLP implementation Hold time study Testing Preparation of working standard.

QA

IPQA observation. Batch Release & Issuance of Control Record Technology Transfer, Documentation & Approval SOP preparation and compliance, Document Distribution & Control Product Quality Review and Trend Analysis. Process Validation Audit Preparation and hosting ISO/GMP Implementation.

Ensuring Sustainability At All Levels

  • Sustainability

    As we grow, we strive to make business sustainable across all levels . Simply put we define sustainability as : Doing more with less resources . We measure sustainability on below parameters :

  • Economic

    Profitability is vital for the business, it ensures its survival. Ensuring that our business can grow, employees recruited and operate profitably in the future, what we do environmentally and socially must go hand in hand with the profitability of the business.

  • Environmental

    Continual and remarkable improvement in product development and in each stage of the operations to facilitate better efficiency and higher customer satisfaction.

  • Social

    As regards the social aspects of sustainability management, our business should be run as a “good citizen”. This means that our business has to take both “internal” and “external” responsibility. We firmly believe and shall act that no one should be exploited in the production of what we sell.

Location

Visit to explore

Plot No. 284/1, GIDC Estate, Makarpura, Vadodara - 390010, Gujarat - India.

Make a Call

Let’s talk with our experts

Front Desk: +91- 265 - 2658894

Send a Mail

Dont’s hesitate to mail

info@spcls.co.in