Pharmaceutical Services
Chemeca Drugs leverages its India cost-base together with its extensive expertise and technology platforms to offer competitive, high quality, custom manufacturing services to a global clientele. Chemeca Drugs’ full set of customer manufacturing capabilities in synthetic chemistry is well known throughout the industry.
cGMP API Manufacturing
We conduct cGMP manufacturing of API’s from bench top volumes to multi-kilos. Our R&D and cGMP manufacturing areas can support different reactor sizes. Our four clean API suites are rated at ISO Class 8, whereas most of our competitor’s cGMP API suites are either Class 100,000 (Class D) or entirely unrated. We are currently involved in the small-scale cGMP contract manufacturing of active pharmaceutical ingredients in many drug classes. Our integrated services offer to allow our customers to move their API products from inception all the way through to cGMP manufacturing all in one company. Chemeca Drugs brings more than a decade of chemistry experience to all API Intermediates and API synthesis projects and we ensure cGMP compliance with our rigorous quality systems.
API Validation (Synthetic)
At Chemeca Drugs we pay special attention to equipment qualification and process validation to provide full regulatory compliance for our cGMP API manufacturing clients. We follow the strictest guidelines, perform the most rigorous testing, and execute studies in a timely fashion to ensure that your product is of the highest quality when it reaches its destination. Chemeca Drugs can develop, create and execute validation protocols and studies required for your products and equipment in accordance with current Guidelines (U.S. FDA, Health Canada , EMA, ICH, WHO) and acceptable formats (prospective, retrospective and concurrent). These include process validation, cleaning validation, environmental control, IQ/OQ/PQ/PV and utility qualifications. Statistical analysis and decision making analysis are also part of our service.
Contract Manufacturing
Chemeca Drugs Private Limited offer world class products and services related to the manufacturing of intermediates and active pharmaceutical ingredients (APIs). This division will deliver fully-consolidated or customized manufacturing solutions for APIs, intermediate chemicals and new chemical entities.
Product Development
- Rigorous Literature evaluation
- Cost effective & environment friendly process/ROS
- Robust & scalable process
- Complete tech-pack preparation
- CMC documentation support
- Preparation of working standards & impurities