Custom Manufacturing, Project Outsourcing, your Trusted Partner from China
The pharmaceutical industry is governed by a rigorous framework of regulations and quality standards designed to ensure the safety, efficacy, and reliability of medicines. Central to this are the manufacturing practices and quality assurance protocols for pharmaceutical intermediates, the foundational components of APIs. NINGBO INNO PHARMCHEM CO.,LTD. understands this intrinsically, prioritizing adherence to globally recognized standards such as Good Manufacturing Practices (GMP), ISO 9001, and FDA guidelines in the production of critical intermediates like the one used for Acalabrutinib synthesis (CAS 1420478-88-1).
GMP (Good Manufacturing Practices) is a system for ensuring that products are consistently produced and controlled according to quality standards. For pharmaceutical intermediates, this means meticulous control over raw materials, manufacturing processes, facility hygiene, and documentation. NINGBO INNO PHARMCHEM CO.,LTD.'s commitment to GMP ensures that every batch of (2S)-2-(8-Amino-1-Bromoimidazo[1,5-a]Pyrazin-3-yl)-1-Pyrrolidinecarboxylate meets the highest levels of purity and consistency, making it a trusted component for API manufacturers.
ISO 9001 certification is a testament to a company's robust quality management system. By implementing ISO 9001, NINGBO INNO PHARMCHEM CO.,LTD. demonstrates its ability to consistently provide products and services that meet customer and regulatory requirements. This certification not only enhances operational efficiency but also builds confidence among clients, assuring them of a reliable partner in their complex supply chains.
Furthermore, FDA (Food and Drug Administration) compliance is crucial for any chemical or intermediate intended for use in pharmaceuticals destined for the United States market. While specific FDA approval may not be required for all intermediates, understanding and adhering to FDA principles in manufacturing and documentation is essential for smooth integration into the regulated pharmaceutical production process. NINGBO INNO PHARMCHEM CO.,LTD.'s alignment with FDA expectations facilitates market access and regulatory approval for their clients' final drug products.
In essence, the quality certifications held by suppliers like NINGBO INNO PHARMCHEM CO.,LTD. are not mere badges; they are foundational pillars that support the entire pharmaceutical value chain. When procuring essential intermediates for drugs like Acalabrutinib, partnering with a supplier that champions these rigorous standards is paramount for ensuring product integrity and patient safety.
Manufacturing Facilities
Professional Export Experience
to Global Customers
1. 20 years of R&D, manufacturing and sales experience, serving customers in 60 countries and regions around the world;
2. Own R&D laboratory, pilot platform and large-scale production workshop, which can meet the audit requirements of global customers;
3. We can satisfy customers' perfect transition from small scale lab requirements (gram level) to commercialization requirements (hundred tons level).
A: We don't have Minimum Order Quantity, exact quantity should be provided before quotation for us to calculate the exact cost.
A: We don't provide free samples due to lots of request and expensive international courier's cost, we can deduct the sample charge after commercial order placed.
A: Our payment terms: Small or sample order: T/T IN ADVANCE. Commercial order: First order should be by T/T IN ADVANCE or L/C at sight, and following orders T/T 30~90days is acceptable subject to approval of credit application.
