cGMP and non-GMP intermediates
Materials, Polymer intermediates
Process Development
Process development plays vital role in the manufacture of APIs (NCEs and generic).
GSAI Pharma fully-equipped process research and development lab allows rapid development of scalable and robust chemical processes utilizing advanced methodologies. GSAI Pharma is also equipped with a kilo lab for a quick supply in the early phase of the development.
Our top notched scientists are experts to develop the robust process using PROCESS principles such as Proven, Repeatable, Owner driven, Compatible, Executable, Sustainable, Successful and also SELECT principles such as Safety, Environment, Legal, Economics, Control and Throughput. Our scientists are also experts to develop the sustainable process using GCbD (Green Chemistry by Design).
Our Team offer:
- Early phase process development.
- Late phase process development.
- Commercial scale process development.
- API process development.
- Life cycle management.
Medicinal Chemistry
API Services
The main objectives of GSAI PHARMA are to become a leading company in developing a novel route or non-infringing route for APIs. Our API division has a very outstanding expert route scouting team that can offer the development of novel synthetic routes or non-infringing routes for off-patent APIs.
GSAI is dedicated to providing customers with each kind of high quality biological small-molecule inhibitors (including inhibitor, agonist, and modulator). The products cover a wide range and we are keeping on forming a systematized after-sale service in order to achieve customer satisfaction.
The competitive cost and quality is our main strengths when it comes to finding the off-patent APIs . Our route scouting team will collaborate with customers to identify opportunities early and work closely with them to ensure timely availability of APIs to reinforce their filings and ensure timely market entry.
GSAI PHARMA’S API team offers:
- Process validation of APIs
- Novel synthetic route for off-patented APIs / APIs
- Process development of APIs
- Manufacture of APIs (GMP and non-GMP).
- Non-infringing processes for off-patented APIs / API
Pharma Guide
GSAI Pharma helps the customers to grow without the size of the company and make a huge progress in their drug development and commercialization programs.
Our company has a large network of Advisor–Associates able to support clients with broad and deep expertise and experience and excellent team who perform the tasks perfectly.
We started helping companies to outsource API needs since 2012. Meanwhile our company started helping other companies in other fields ,because customers demanded us to help in other areas and add capacity which made us expand our capabilities. Nowadays ,GSAI leverages our network of experts to pull the best resources into our growing network.
GSAI Pharma Provides its cGMP services in WHO-GMP,ISO-9001:2015 Certified Chemical Phytochemical manufacturing company producing high quality Active Pharmaceutical Ingredients. (API’s)
GSAI performs services that are:Isolation expertise
GSAI PHARMA can provide with guaranteed exclusive Active Pharmaceutical Ingredients (APIs) and qualifies as WHO-GMP Certified Phytochemical manufacturing company standards.
GSAI PHARMA who accepts cGMP guidelines and manufacturing activity is led by an excellent and very proficient team supervised by expert scientists, to ensure high-quality compliance with regulatory authorities and provides APIs fulfilling specifications of various international Pharmacopoeia.
Our company development experts use a simple and cost-effective business model to provide targeted expertise and broad development experience to help you move forward while managing risk, cost and time. GSAI’s pursuit is to develop and supply world class Phytochemical APIs and our company has moved into this journey to change the world, for a better..
We can relate our company to the successful list of companies who lead with proficient teams. We have started a full-fledged Research and Development (R&D) centre to bolster our team in accomplishing our goals. With us, you would never compromise on the quality, safety and efficacy of our products. Our Company is dedicated to observe the highest required standards and excellent business practices , and to maintain the status of integrity at all levels of business.
Formulations
