编号 No |
项目名称 Project name
|
适应症以 Indications |
工作进程 Work process |
详细 Details |
01 |
盐酸利多卡因眼用凝胶 Lidocaine Hydrochloride Eye Gel |
眼科手术,局麻 Eye surgery, local anesthesia 3.5%(5ml:0.175g;1ml:0.035g)
|
在研 At the research institute
|
详细 Details |
02 |
卡波姆眼用凝胶 Carbomer Eye Gel |
干眼症 Dry eye 10g:20mg(0.2%)
|
在研 At the research institute |
详细 Details |
03 |
复方氯替泼诺妥布霉素滴眼液 Compound Loteprednol Tobramycin Eye Drops
|
眼部炎症 Eye inflammation 5ml:氯替泼诺25mg与妥布霉素15mg
|
技术成熟 Mature technology |
详细 Details |
04 |
氯替泼诺原料药及混悬滴眼液 Loteprednol bulk drug and suspension eye drops |
1.眼睑和球结膜炎症 2.眼部手术后的术后炎症 1.
Inflammation of the eyelids and bulbar conjunctiva
|
技术成熟 Mature technology |
详细 Details |
05 | 他克莫司滴眼液研 Tacrolimus Eye Drops Research
|
0.1% |
在研 At the research institute |
详细 Details |
06 |
环孢素眼用乳液(胶束) Cyclosporine ophthalmic emulsion (micelle) |
干眼症 Dry eye 规格:0.09%
|
在研 At the research institute |
详细 Details |
07 | 贝美前列素 Bimatoprost Ophthalmic Solution
|
开角型青光眼、高眼压症 Open angle glaucoma, ocular hypertension |
已申报 Declared |
详细 Details |
08 | 曲伏前列素 Travoprost Eye Drops
|
开角型青光眼、高眼压症 Open angle glaucoma, ocular hypertension |
即将批准生产 Approved for production soon |
详细 Details |
09 |
二氟泼尼酯眼用乳剂 Difluprednate Eye drops |
眼科术后出现的炎症和疼痛 Inflammation and pain after ophthalmology surgery
|
原料工艺确定,分析方法,质量标准已确定,制剂工艺确定 The material technology is determined, the analysis method, the quality standard has been determined, and the preparation technology is determined |
详细 Details |
10 |
地夸磷索钠滴眼液 Diquafosol Sodium Eye Drop s |
治疗干眼症 Treatment of dry eye
|
原料工艺确定,分析方法,质量标准已确定,制剂工艺确定 The material technology is determined, the analysis method, the quality standard has been determined, and the preparation technology is determined
|
详细 Details |
11 |
奈帕芬胺滴眼液 Pranoprofen Eye Drops |
白内障术后疼痛和炎症 Pain and inflammation after cataract surgery
|
原料工艺确定 Raw material process determination |
详细 Details |
12 | Omidria复方眼用洗液 Omidria Compound eye lotion
|
内障和晶状体置换手术中的 扩瞳药物,以防止手术 中瞳孔缩小及缓解术后疼痛。 In cataract and lens
replacement surgery
|
原料来源确定,制剂处方工艺确定 The source of raw materials is determined, and the formulation process is determined. |
详细 Details |
13 | (酮咯酸氨丁三醇-盐酸去氧肾上腺素) Omidria Compound Eye Lotion
|
技术成熟 Mature technology |
详细 Details |
|
14 | 普拉洛芬滴眼液 Pranoprofen Eye Drops
|
外眼及眼前节炎症的对症治疗 Symptomatic treatment of inflammation of the outer eye and anterior segment
|
工艺确定,杂质具备 The process is confirmed, and the impurities are available |
详细 Details |
15 |
瑞巴派特混悬滴眼液 Rebate Pitt Drops |
干眼症 Dry eye
|
负责进口注册申报,已批临床 Responsible for import registration declaration, clinical approved
|
详细 Details |
16 |
莫西沙星滴眼液 Moxifloxacin Hydrochloride Eye Drops |
抗生素 Antibiotics
|
工艺研究完成 Process research is completed. |
详细 Details |
17 | 复方托吡卡胺滴眼液(单剂量) Tropicamide Phenylephrine Eye Drops(Single dose)
|
诊断及治疗为目的的 散瞳和调节麻痹 For the purpose of diagnosis
and treatment
|
实验室研究完成 Laboratory research completed |
详细 Details |
18 |
他氟前列素原料药及滴眼液 Tafluprost Eye Drops and API |
降低开角型青光眼 或眼高压患者的眼内压 Reduce open angle glaucoma
|
技术成熟 Mature technology |
详细 Details |
19 | 阿卡他定滴眼液 LASTACAFT EYE DROPS
|
用于预防与过敏性 结膜炎相关的瘙痒
For prevention and allergy
|
技术成熟 Mature technology
|
详细 Details |
20 |
立他司特原料药及滴眼液 Lifitegrast EYE DROPS and API |
治疗有体征和 症状的干眼症 Treatment has signs and
|
技术成熟 Mature technology |
详细 Details |
21 | 阿托品滴眼液 Atropin EYE DROPS
|
详细 Details
|
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22 |
环孢素眼用乳剂 Cyclosporine ophthalmic emulsion
|
干眼症 Dry eye 规格为0.05%
|
1)目前,该制剂工艺开发并优化完成,单剂量规格(0.05%/0.4ml)已经过GMP车间10万支/批放量生产,工艺稳定,产品质量与原研一致,且稳定性等与原研一致。 1) At present, the preparation process has been developed and optimized. The single-dose specification (0.05%/0.4ml) has been produced in a GMP workshop of 100,000 pieces/batch. The process is stable, the product quality is consistent with the original research, and the stability is consistent with the original research. . 2)0.05%/3ml工艺、质量研究难度大,现已确定。 The process and quality of 0.05%/3ml are difficult to study, and it has been determined. 3)具备批文的合法原料药,且杂质制备获取完备 Legal APIs with approved documents and complete preparation of impurities. 4)分析方法,质量标准建立完善,单剂量申报资料已提交申报,多剂量正在完成。 Analytical methods, quality standards have been established and perfect, single-dose application materials have been submitted, and multiple-dose applications are being completed 5)已获临床批件。技术成熟 Has been clinically approved. Mature technology
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详细 Details |
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