喷他佐辛注射液获得研制立项批件 Pentazocine inj approved of developmemt

2018年9月13日，美享医药获得国家药品监督管理局颁发的麻醉药品和精神药品研制立项批件，同意我公司引进的印度生产的喷他佐辛注射液进口立项。
On September 13, 2018, Maxmind Pharma was granted approval for the development of narcotic drugs and psychotropic drugs by CFDA, agreeing to the import of Pentazocin injection from India.

喷他佐辛注射液为人工合成阿片类药，是临床必需的镇痛及麻醉辅助用药，按照我国药品管制规定，属第二类精神药品。目前在国内市场上获批生产销售的仅有华润双鹤药业股份有限公司，为1998年上市，未见通过仿制药一致性评价信息。
As a kind of synthetic opioid, Pentazoxine injection is a analgesic and anesthetic assistant drug of clinical need .At present, only CR Double Crane pharmaceutical co., ltd. has been approved for production and sales in China, which was launched in 1998, and has not passed the generic drug consistency evaluation.

我公司引进的印度生产的喷他佐辛注射液，执行英美药典，生产厂具备WHO GMP证书，是与原研质量、疗效一致的国际先进水平仿制药，可保证临床必需止痛药品喷他佐辛注射液的高质量供应，大大提高广大患者临床获益。
The product is manufactured according to BP and USP, while adopting WHO GMP, is an advanced generic consistent with the reference product both in quality and efficacy, will greatly improve the clinical benefit of the patients.

我公司已在整理准备该产品进口注册申报资料，预计年内可提交国家药品监督管理局。
Our company has been preparing the registration dossier, and expected to make the submission within the year.