Acalabrutinib

Details:

Shanghai Hope-Chem Co.,Ltd is high-tech company integrated with the R&D, production and marketing. It was establish in 2014. The main products are APIs and intermediates of antiviral drug substances and anti-inflammatory, analgesic, non-steroidal pharmaceuticals.

Indrastructure& Facility:

Our GMP plant covers about 43,000.m², the total employee is about 560, more than 42% of personnel have the college above education background, more than 160 people are engineer and technicians. The total asset is about RMB806 million. The products, more than 80%, are exported to overseas including Europe, USA, Asia and twenty other countries.

In March 2015, the Group established a R&D company in New York which specialized in in-America new drug development, FDA registration and market channel connecting. The company has submitted drug registration application to FDA.

Research and Development:

The GMP plant prides itself for being an organizations that thrives on a robust research and development program. We have started investing in R&D in the very beginning of establishment, which gave us a head start for developing an expansive basket of products to meet diverse market requirements across the globe.Also, our extensive focus on R&D helped us transcend API research to successfully expand our capabilities into the realm of API’s and Pharmaceutical Intermediates. In fact, research is a mainstay of our business goals.

Our creative and experienced process chemists are dedicated to design and develop synthetic processes that are experimentally friendly and economically viable.

Quality Control:

A well-equipped advanced lab for quality testing according to the pre-determined MOA as per pharmacopoeia or in-house developed and validated analytical methods, we preform the analysis in compliance with the ICH guidelines.

Quality Assurance:

The GMP plant aim at achieving a high degree of quality in our products and services.

Our vision is to achieve international standards of quality, through persistent hard work and better implementation of knowledge by the people and having quality policy in place. Our quality systems are designed as per ICH guidelinesto implement these standards. We have a thorough training and re-training program in place.

Some of the important activities handled by quality Assurance team.

Document control & Annual product reviews

Monitoring of all validations including cleaning validations

Charge control compliance, batch release & product recall

GMP training & awareness

R&D Strength:

Our team is comprised of an equal balance between process and analytical chemists who work side-by-side to develop safe, salable, efficient and cost-effective chemical processes. Our broad base of chemical development expertise includes:

Heterocyclic Chemistry

Enzymatic Reactions (Diester hydrolysis, Ketone reduction)

Chiral Resolutions(Use of Chiral Amnies and Chiral Acids )

Asymmetric Synthesis (Use of Chiral Catalyst, Chiral Auxliaries)

Cross-coupling Reactions(Suzuki, Heck and Buchwald)

Carbohydrates Reactions