Lincomycin hydrochloride monohydrate

Product Category:Pharmaceutical raw materials

Cas.NO:7179-49-9

Quality standard: ChP/USP/EP
Registered trademark: North Anhui
Packaging: 20kg(active)/ drum; 25 kg/drum; Customer requirements.
Domestic and international registration:

 

China NMPA	Drug approval number: SFDA approval numberH34020969 CDE Registration no.: Y20190002010
America FDA	DMF register DMF No.: 19056
EU EDQM	CEP certificate Certificate number: R0-CEP 2017-168-Rev01 Certificate number: R0-CEP 2020-105-Rev 00
Japan PMDA	MF register MF No.: 231MF10034
Canada	MF register: MF No.: f2015906

 

Products honor

 In November 2018, lincomycin hydrochloride production line successfully passed the on-site inspection of PMDA GMP certification of Japan and obtained the Notice of Investigation Result of Medical Conformity.（Serial number: AA37150）
• In March 2014 and October 2017, lincomycin hydrochloride production line passed the German GMP certification review and inspection twice.
•In March 2013, September 2016, and March 2019, lincomycin hydrochloride production line successfully passed America FDA cGMP  inspection for three times.
• The project "Breeding of Lincomycin Producing Strain by Modern Mutagenesis Technology and Its Industrialization Research" won the third prize of Anhui Provincial Science and Technology Progress Award in 2013.
• In October 2013, "Lincomycin Hydrochloride Fermentation and Extraction" project was listed as a core patent industrialization project by Anhui Intellectual Property Office (ZL 2009 1 0144359.5).
• In November 2011, the invention patent of "a production method of lincomycin hydrochloride" was authorized (ZL 2009 1 0144359.5).
• In April 2011, passed the on-site inspection of German GMP certification and obtained the German GMP certificate.
In March 2010, lincomycin hydrochloride  production line successfully passed America FDA cGMP certification (DMF No.19056).
• In 2009, the scientific and technological achievements of "using genetic engineering and other new technologies to improve lincomycin producing bacteria and industrial development" won the third prize of scientific and technological progress in Anhui Province.
• In 2005, undertaken the National Torch Program Project "Optimized Strain and New Resin Adsorption Process for the Production of Lincomycin Hydrochloride Active Pharmaceutical Vinaigrette"
• The project "Using Genetic Engineering and Other New Technologies to Improve Lincomycin Producing Bacteria and Industrial Development" undertaken in 2005 (Anhui Province "Tenth Five-Year Plan" Major Science and Technology Special Project) passed the acceptance of the results.
• In 2000, lincomycin hydrochloride products won the first prize of outstanding high-tech products in Anhui Province.
• In 2000, the project "Lincomycin High-yield and High-quality Strain Breeding and New Technology Research" won the second prize of Science and Technology Progress of Anhui Province.
• 1999 Lincomycin Hydrochloride Active Pharmaceutical Ingredients was approved as a high-tech product.
• In 1999, lincomycin hydrochloride raw materials and injections were rated as "Anhui Famous Brand Products".
• In 1999, "Wanbei" brand lincomycin active pharmaceutical ingredient and injection was awarded "Famous Trademark of Anhui Province" by Anhui Administration for Industry and Commerce

【English name】Lincomycin Hydrochloride 
【Chinese pinyin】Yansuan Linkemeisu 
【Structural formula】 
【Molecular formula】C₁₈H₃₄N₂O₆S·HCl·H₂O
【Molecular weight】461.02
【Appearance】This product is white crystalline powder; Have a slight odor or special odor; Bitter taste. 
【Category】This product is an antibiotic drug. Its preparation is effective against respiratory tract infection, skin and soft tissue infection, female genital tract infection and pelvic and abdominal infection caused by sensitive staphylococcus, streptococcus, streptococcus pneumoniae and anaerobe, the latter two diseases can be used alone or in combination with other antimicrobial agents according to the situation. In addition, this product can be used as an alternative drug for patients with indications of penicillin use, such as patients allergic to penicillin or those who are not suitable for penicillin use. 
【Packing】20kg(active)/ barrel; 5kg(active)/ tin; 25 kg/barrel.