Generic Drug Development Service Platform

A generic drug is a copy that is the same as a brand name drug in terms of dosage, safety, and strength (regardless of how it is taken), quality, performance, and intended use.

 

During development progress, comprehensive and in-depth comparison with original drug product should be carried out, including but not limited to the critical attributes, such as formulation, manufacturing process, quality specification, crystal form, impurities and the dissolution profiles of solid dosage. Then the generic drug will be proved to have the same efficacy as the original drug product through the bioequivalence study in human volunteers.

 

Shanghai Xihua Pharmaceutical Co., Ltd. can provide one-stop service of generic drug product development from API synthesis to drug product submission, complied with the regulations of China NMPA, FDA/EU/WHO, etc..

 

Our advantages:

Ø One-stop service of consistency evaluation of generic drug development and generic drug product development complied with the regulations at home and abroad. The service includes analysis of RLD (reverse engineering), pre-formulation studies, formulation and process development, analytical procedures development and validation, scale-up manufacturing, process validation manufacturing, stability samples test, preparation of submission documents.

Ø Core team members are all from world famous generic drug company, has rich first-hand development experience for numerous generic drug development FDA for CFDA/EU/WHO.

Ø Core team members have rich experience about formulation and process development, scale-up, technical transfer and analytical method development and validation

Ø Integrity quality assurance system

Ø Equipped completely and advanced instruments to ensure high-efficient development

Core team members

The core team of Xihua Pharmaceutical consist of senior experts from global well-known Generic company of Teva, and experts from famous pharmaceutical companies of China.

 

Service Category

Ø Oral Dosage: immediate-release tablet, sustained-release tablet, controlled-release tablet, delayed-release/enteric release, dispersible tablet; hard capsules, softgel capsules; pellets; oral solution, etc.

Ø Injections: small-volume, large-volume injections, lyophilized products, etc.

Ø Eye drops: single dose eye drops, multi-dose eye drops, etc.

 

Laboratory Equipment

Xihua Pharmaceutical has more than 3,000 m2 of laboratory and office space, and has new and advanced equipment and facilities, including but not limited to the equipment for the formulation and process development for oral dosage, injections, eye drops and corresponding analytical testing equipment.


Generic Drug Development Service Platform

 

Generic Drug Consistency Evaluation Service Platform

高效液相色谱仪HPLC

Generic Drug Consistency Evaluation Service Platform

扫描电镜 SEM

Generic Drug Consistency Evaluation Service Platform

电感耦合等离子体质谱ICP-MS

Generic Drug Consistency Evaluation Service Platform

气相色谱-质谱仪GC-MS

Generic Drug Consistency Evaluation Service Platform

德国GLATT(格拉特)流化床 GLATT Fluidized Bed

Generic Drug Consistency Evaluation Service Platform

德国GLATT(格拉特)制粒机GLATT High-shear Granulator

 Generic Drug Consistency Evaluation Service Platform

高效包衣机 High Efficiency Coater

Generic Drug Consistency Evaluation Service Platform

干法制粒机 Roller Compactor

Generic Drug Consistency Evaluation Service Platform

德国CHRIST冷冻干燥机Germany CHRIST Lyophilizer

 Generic Drug Consistency Evaluation Service Platform

软胶囊机Softgel Capsule Machine


 

Specific services as follows:

1 Pre-formulation Studies

1.1 Literature Research

Ø Drug substance information in Pharmacopoeia in different countries

Ø Drug substance stability, analytical method, impurities and so on in literature

Ø Information of reference listed drug (RLD) and reference standard (RS)

Ø Information such as formulation, manufacturing process, or stability of the marketed product in different markets

Ø Analysis and comparison of formulations, processes, stability and so on of marketed drug products in various countries

1.2 Evaluation of Drug Substance

Ø Analytical method development, optimization and confirmation, such as assay, relevant substance.

Ø Drug substance supplier recommendation through evaluation and comparison of drug substance from different suppliers.

Ø Evaluation of the drug substance solubility (solubility curves in various organic solvents and acid-base solvents, and solubility in simulated gastric and intestinal fluids)

Ø Evaluation of the stability (including the stability under high temperature, high humidity, light, etc.; stability under acidification, alkalization, oxidation and in solutions with various pH)

Ø Evaluation and analysis on gene impurities of drug substance

Ø Evaluation and analysis on element impurities of drug substance

Ø Analysis of crystal form of drug substance

1.3 Reverse Engineering on Reference Listed Drug (RLD)

Ø Analysis on crystal form of drug substance in RLD

Ø Analysis on types and grade of excipients in RLD

Ø Analysis on amount of excipients in RLD

Ø Analysis on assay and impurities of drug substance in RLD

Ø RLD dissolution profiles in multi-medium solutions.

Ø RLD stability studies

1.4 Compatibility Study

 

2 Formulation and Process Development and Optimization of Drug Product

Ø Define the critical quality attributes of finished product

Ø Develop the evaluation method of critical quality attributes (including solid dosage multi-medium dissolution profiles and discriminating dissolution method)

Ø Selection of drug product manufacturing process

Ø Selection of excipients grade

Ø Development of formulation and process (including the development on lyophilized curves of lyophilized product)

Ø Optimization of formulation and process (including optimization on lyophilized curves of lyophilized product)

Ø Comprehensive quality comparison with RLD

Ø Selection of packaging material (including the compatibility study of packaging material and pipe material)

Ø Stability study of test product (including Stress testing) and comparison with RLD

Ø Establish finished product quality specification

 

3 Process Scale-ups, Technique Transfer and manufacturing the Submission Batches

Ø Validation and transfer of analytical method

Ø Preparation and review of scale-up/submission batch protocols

Ø Preparation and review of scale-up/submission batch manufacturing records

Ø On site support during the scale-up/submission batch manufacturing

Ø Preparation and review of scale-up/submission batch report

 

4 Stability Study

Ø Stress testing of test product and RLD

Ø Accelerated/long-term stability study of Test product and RLD

Ø Compatibility study of packaging material (such as extractables, leachables)