Qitl

Qitl is committed to drug research and development, including raw materials, plant extracts, solid preparations, aerosols, injections, oral liquids, ointments, innovative drugs CMC, genotoxicity and element impurities, drug packaging materials, process components, method development, etc. Quality research and overall research. Qitl focuses on drug synthesis, formulations, quality analysis, drug packaging compatibility research, microbiology, standard physical and chemical testing, drug registration and application, and other comprehensive drug development and drug clinical trial research.

Qitl's pre-clinical research on chemical drugs for drug registration, including the synthesis process of chemical drugs, extraction methods, physical and chemical properties and purity, dosage form selection, prescription screening, preparation process, inspection methods, quality indicators, stability, pharmacology, toxicity Physics, animal pharmacokinetics; and pre-clinical studies of biological products including bacterial strains, cell strains, biological tissues, starting material quality standards, storage conditions, genetic stability and immunology.

Registration Declaration

Qitl Pharmaceutical currently has more than 30 full-time imported drug registration elites on duty.

Qitl selects products suitable for introduction into China based on factors such as patents, pharmacology, toxicology, side effects, therapeutic advantages, product characteristics, intermediate structure, domestic environmental protection, and capacity conversion of domestic pharmaceutical manufacturers.

For imported drugs, marketing authorization includes drug registration approval documents, imported drug registration standards, and imported drug license (Imported Drug License-IDL). These documents are issued at the same time as IDL is issued. The industry usually refers to marketing authorization documents collectively as IDL. IDL is issued by NMPA, and the process from application to IDL is called import drug registration or IDL application.

Approved Varieties    Related Varieties    Variety in report    National Medicine Standard

Psychotropic Drugs

ideal Medicine attaches great importance to the research and development of psychotropic drugs. It has obtained the pre-approval from the National Medical Products Administration [National Medical Products Administration-(NMPA)] to establish a psychotropic drug research laboratory.

The second-class psychotropic drug "phenobarbital tablets" successfully obtained the drug GMP certificate: On February 2, 2019, Shanghai Ideal Pharmaceutical Co., Ltd. successfully obtained the "drug GMP certificate".

The second-class psychotropic drug caffeine tablets project approval was approved: Shanghai Ideal Pharmaceutical Co., Ltd.'s second-class psychoactive drug "caffeine tablets" was approved for experimental research by the National Medical Products Administration on November 6, 2019, approval number: TYL2019- 0240.

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