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R&D Services
Cutting-edge research and development, creating a shield for life
Generic Drugs

Generic Drug R&D Services

Focused on topical generic development across ointments, patches, sprays and gels, providing one-stop R&D from formulation and process to quality studies and registration.

R&D services

Service Series

  • Ointment
  • Gel
  • Spray
  • Patch
  • List of ongoing research
Research and development of ointment drugs
Ointment

Ointment (Ointment) is a uniform semi-solid topical preparation made by mixing the raw drug with an oily or water-soluble matrix.

At present, Gaomai Pharmaceutical has established a ointment technology platform, mastering the dosage form characteristics of oil-based bases mainly based on white vaseline and water-soluble bases mainly based on polyethylene glycol, and providing a one-stop solution from research and development to application. The semi-solid laboratory is equipped with formulation research and development equipment of different scales, including high-speed dispersion homogenizers, vacuum homogenizing emulsifiers, etc., which can meet the requirements of small-scale trials and pre-amplification research of formulations.

It is also equipped with multiple analytical and testing instruments, including fully automatic transdermal diffusion meters, rheometers, polarizing microscopes, viscometers, high-performance liquid chromatographs, etc., covering the entire process of ointment quality research.

Cream

Cream refers to a uniform semi-solid preparation formed by dissolving or dispersing the raw drug in an emulsion matrix.

At present, Gaomai Pharmaceutical has established a cream technology platform, mastering the characteristics of O/W (oil-in-water) or W/O (water-in-oil) structural dosage forms, and providing a one-stop solution from research and development to application. The semi-solid laboratory is equipped with formulation research and development equipment of different scales, including high-speed dispersion homogenizers, vacuum homogenizing emulsifiers, etc., which can meet the requirements of small-scale trials and pre-amplification research of formulations.

It is also equipped with multiple analytical and testing instruments, including fully automatic transdermal diffusion meters, rheometers, polarizing microscopes, viscometers, high-performance liquid chromatographs, etc., covering the entire process of cream quality research.
Research and development of gel-like drugs
A Gel refers to a thick liquid or semi-solid preparation with gel-like properties, which is made from raw drugs and excipients that can form a gel.

At present, Gaomai Pharmaceutical has established a gel agent technology platform, mastering the characteristics of dosage forms such as carbomer matrix and cellulose derivative matrix, and providing a one-stop solution from research and development to application. The semi-solid laboratory is equipped with formulation research and development equipment of different scales, including high-speed dispersion homogenizers, vacuum homogenizing emulsifiers, etc., which can meet the requirements of small-scale trials and pre-amplification research of formulations.

It is also equipped with multiple analytical and testing instruments, including fully automatic transdermal diffusion meters, rheometers, polarizing microscopes, viscometers, high-performance liquid chromatographs, etc., covering the entire process of gel agent quality research.
Research and development of spray drugs
A Spray refers to a preparation in which the raw drug or suitable excipients are filled in a specially designed device. When used, the contents are released in a mist form by means of the pressure of a manual pump, high-pressure gas, ultrasonic vibration or other methods, and are directly sprayed onto the mucous membranes or skin of cavities, etc.

Sprays are classified into solution type, emulsion type or suspension type based on the composition of their contents. The sprays should undergo the following corresponding inspections, including: total number of sprays per bottle, the amount of each spray, the content of the main drug per spray, the uniformity of the delivered dosage, and the difference in filling volume, etc.

At present, Gaomai Pharmaceutical has established an external spray platform, providing a one-stop solution from research and development to application.
Research and development of plaster drugs
The Transdermal drug delivery system (TDDs) refers to a drug delivery route in which drugs are absorbed through the skin into the human bloodstream and reach an effective blood drug concentration to achieve disease prevention or treatment. It is the third major drug delivery system after oral administration and injection administration. It has the advantages of good therapeutic effect and self-medication, and to a certain extent, it solves the problems such as first-pass metabolism, peak-valley phenomenon and poor compliance of traditional drug administration methods.

There are mainly three types of modern transdermal patches: gel patches (Cataplasm), hot melt patches (Tape), and solvent patches (Patch). At present, Gaomai Pharmaceutical has established a transdermal patch technology platform, focusing on the development of transdermal drug delivery preparations for chemical drugs and traditional Chinese medicine, and providing one-stop solutions from research and development to application. The patch laboratory is equipped with advanced formulation research and development equipment, including planetary mixers, high-speed dispersion homogenizers, small-scale experimental coating machines, laboratory hot melt adhesive coating machines, pilot-scale experimental coating units and other equipment, which can meet the needs of small-scale and pilot-scale formulation trials.

It is equipped with multiple analytical and testing instruments at the same time, including fully automatic transdermal diffusion instrument, initial adhesion tester, holding adhesion tester, adhesion force tester, rheometer, polarizing microscope, external preparation particle size analyzer, etc., covering the entire process of patch quality research..

阿达帕林凝胶

prescription type:OTC

medical indications:医保乙类

specification::0.1%(30g;30mg)

status::已获批

indications::适用于以粉刺、丘疹和脓包为主要表现的寻常型痤疮的皮肤治疗。亦可用于治疗面部、胸和背部的痤疮。

basic drug:

克立硼罗软膏

prescription type:Rx

medical indications:医保乙类

specification::2%(30g:0.6g)

status::已获批

indications::适用于2岁及以上轻度至中度特应性皮炎患者的局部外用治疗。

basic drug:

盐酸阿莫罗芬乳膏

prescription type:OTC

medical indications:医保乙类

specification::0.25%(20克:50毫克,按阿莫罗芬计)

status::已获批

indications::用于由皮肤真菌引起的皮肤真菌病:足癣(脚癣,运动员脚),股癣,体癣,皮肤念珠菌病。

basic drug:

莫匹罗星软膏

prescription type:OTC

medical indications:医保乙类

specification::2%(15g:0.3g)

status::已获批

indications::本品为局部外用抗生素,适用于革兰阳性球菌引起的皮肤感染,例如:脓疱病、疖肿、毛囊炎等原发性皮肤感染及湿疹合并感染、不超过10厘米×10厘米面积的浅表性创伤合并感染等继发性皮肤感染

basic drug:

夫西地酸乳膏

prescription type:Rx

medical indications:医保乙类

specification::15g/支

status::已获批

indications::本品主治由葡萄菌,链球菌,痤疮丙酸杆菌,极小棒状杆菌及其他对夫西地酸敏感的细菌引起的皮肤感染。主要适应症包括,脓疮症,疖,痈,甲沟炎,创伤感染,须疮,汗腺炎,红癣,毛囊炎,寻常型痤疮。

basic drug:

过氧苯甲酰凝胶

prescription type:OTC

medical indications:医保乙类

specification::30g/支

status::已获批

indications::寻常痤疮的局部治疗。

basic drug:

利丙双卡因乳膏

prescription type:Rx

medical indications:

specification::30g:利多卡因0.75g与丙胺卡因0.75g

status::已获批

indications::用于下列情况的皮肤局部麻醉-针穿刺,例如:置入导管或采血。-浅层外科手术。例如:生殖器粘膜,在浅层外科手术或浸润麻醉之前;腿部溃疡清洁/清创术。

basic drug:

双氯芬酸二乙胺乳胶剂

prescription type:OTC

medical indications:医保乙类

specification::1%(20g:0.2g)

status::已获批

indications::用于缓解肌肉、软组织和关节的轻至中度疼痛。

basic drug:

盐酸特比萘芬喷雾剂

prescription type:OTC

medical indications:非医保

specification::每瓶为30ml,每克喷雾剂含10毫克盐酸特比萘芬

status::已获批

indications::用于治疗手癣、足癣、体癣、股癣及花斑癣等。

basic drug:

阿达帕林过氧苯甲酰凝胶

prescription type:Rx

medical indications:

specification::30g:阿达帕林30mg与过氧苯甲酰750mg

status::已申报

indications::本品适用于伴粉刺、丘疹和脓疱的寻常痤疮的皮肤治疗。本品适用于成人、青少年和9岁及以上儿童

basic drug:

酮洛芬凝胶

prescription type:OTC

medical indications:医保乙类

specification::2.5%(20克:0.5克)

status::已申报

indications::用于各种骨骼肌损伤的急慢性软组织(肌肉、韧带、筋膜)扭伤、挫伤,以及肌肉劳损所引起的疼痛;也可用于骨关节炎的对症治疗。

basic drug:

硝酸咪康唑乳膏

prescription type:OTC

medical indications:医保甲类

specification::2%(30g:0.6g)

status::已申报

indications::由皮真菌、酵母菌及其他真菌引起的皮肤、指(趾)甲感染,如:体股癣、手足癣、花斑癣、头癣、须癣、甲癣;皮肤、指(趾)甲念珠菌病:口角炎、外耳炎。由于本品对革兰阳性菌有抗菌作用,可用于此类细菌引起的继发性感染。

basic drug:

糠酸莫米松乳膏

prescription type:OTC

medical indications:医保乙类

specification::0.1%(15g:15mg)

status::待申报

indications::用于湿疹、神经性皮炎,异位性皮炎及皮肤瘙痒症。

basic drug:

联苯苄唑溶液

prescription type:OTC

medical indications:医保乙类

specification::1%(10ml:0.1g)

status::待申报

indications::治疗以下皮肤真菌感染: (1)癣:足癣、体癣、股癣; (2)念珠菌病:趾间糜烂、趾间藓、皮肤念珠菌病; (3)花斑癣。

basic drug:

丙酸氟替卡松乳膏

prescription type:Rx

medical indications:医保乙类

specification::0.05%(15g:7.5mg) 0.05%(30g:15mg)

status::待申报

indications::本品是一种适用于成年人、一岁及一岁以上儿童的一种外用糖皮质激素,用于缓解对糖皮质激素有应答的皮肤病的炎症和瘙痒症状。 包括下列: 特应性皮炎(包括婴儿特应性皮炎) 、钱币状皮炎(盘状湿疹) 、结节性痒疹 、银屑病(泛发型除外) 、慢性单纯性苔癣(神经性皮炎)和扁平苔藓、 脂溢性皮炎、 刺激性或过敏性接触性皮炎、 盘状红斑狼疮、 作为红皮病中全身糖皮质激素治疗的辅助药物 、虫咬皮炎 、粟粒疹(痱子) 、减少复发风险 、在特应性皮炎急性发作被有效治疗后,使用本品能减少其复发的风险。

basic drug:

阿昔洛韦乳膏

prescription type:OTC

medical indications:医保甲类

specification::5%(10g:0.5g)

status::待申报

indications::适用于治疗皮肤单纯疱疹病毒感染,包括初发性和复发性生殖器疱疹及唇疱疹。

basic drug:

壬二酸凝胶

prescription type:Rx

medical indications:非医保

specification::15%(30g:4.5g) 15%(5g:0.75g)

status::待申报

indications::用于缓解面部轻度至中度丘疹脓疱性痤疮。 用于丘疹脓疱型玫瑰痤疮的局部治疗。

basic drug:

丁酸氢化可的松乳膏

prescription type:OTC

medical indications:医保乙类

specification::0.1%(30g:30mg)

status::待申报

indications::用于过敏性皮炎、脂溢性皮炎、过敏性湿疹及苔藓样瘙痒症等。

basic drug:

利多卡因喷雾剂

prescription type:Rx

medical indications:非医保

specification::50ml/瓶

status::待申报

indications::皮层局麻。

basic drug:

洛索洛芬钠凝胶贴膏

prescription type:Rx

medical indications:医保乙类

specification::每贴(14.0cm×10.0cm)含膏体10g,含洛索洛芬钠100mg(以C15H17NaO3计)

status::待申报

indications::用于以下疾病及症状的消炎、镇痛:骨关节炎、肌肉痛、外伤后的肿胀疼痛。

basic drug:

双氯芬酸钠凝胶

prescription type:OTC

medical indications:非医保

specification::1%(20g:0.2g)

status::待申报

indications::用于缓解肌肉、软组织和关节的轻至中度疼痛。如缓解肌肉、软组织的扭伤、拉伤、挫伤、劳损、腰背部损伤引起的疼痛以及关节疼痛等。也可用于骨关节炎的对症治疗。

basic drug:

氟比洛芬凝胶贴膏

prescription type:Rx

medical indications:医保乙类

specification::每贴(13.6cm×10.0cm) 含膏体12g,含氟比洛芬40mg

status::待申报

indications::骨关节炎、肩周炎、肌腱及腱鞘炎、腱鞘周围炎、肱骨外上髁炎(网球肘)、肌肉痛、外伤所致肿胀、疼痛疾病及症状的镇痛、消炎。

basic drug:

盐酸特比萘芬乳膏

prescription type:OTC

medical indications:医保乙类

specification::1%(10g:0.1g) 1%(15g:0.15g) 1%(30g:0.3g)

status::待申报

indications::用于治疗手癣、足癣、体癣、股癣、花斑癣及皮肤念珠菌病等。

basic drug:

洛索洛芬钠贴剂

prescription type:Rx

medical indications:医保乙类

specification::50mg/贴(7cm×10cm) 100mg/贴(14cm×10cm)

status::待申报

indications::用于下述疾病及症状的消炎和镇痛:骨关节炎、肌肉痛、外伤导致的肿胀或疼痛

basic drug:

2%双氯芬酸二乙胺乳胶剂

prescription type:OTC

medical indications:医保乙类

specification::2%(30g:0.6g) 2%(50g:1g)

status::待申报

indications::用于缓解肌肉、软组织和关节的轻至中度疼痛。如:缓解肌肉、软组织的扭伤、拉伤、挫伤、劳损、腰背部损伤引起的疼痛以及关节疼痛等。也可用于骨关节炎的对症治疗

basic drug:

盐酸丁卡因凝胶

prescription type:Rx

medical indications:医保乙类

specification::4%(1.5g:60mg)

status::待申报

indications::经皮局部麻醉,在静脉穿刺或静脉插管前对皮肤进行麻醉。

basic drug:

盐酸利多卡因凝胶

prescription type:Rx

medical indications:医保乙类

specification::2%(30g:0.6g)

status::待申报

indications::局麻药、经尿道施行检查和治疗需局部麻醉者。

basic drug:

美沙拉秦栓

prescription type:Rx

medical indications:医保乙类

specification::0.5g/片

status::待申报

indications::本品用于直肠型溃疡性结肠炎的治疗。

basic drug:

克林霉素磷酸酯外用溶液

prescription type:OTC

medical indications:非医保

specification::1%(60ml:0.6g) 1%(30ml:0.3g)

status::待申报

indications::用于治疗寻常痤疮

basic drug:

丙酸氯倍他索头皮敷剂 

prescription type:Rx

medical indications:非医保

specification::0.05%(30ml:15mg) 0.05%(100ml:50mg)

status::待申报

indications::丙酸氯倍他索为超强效外用糖皮质激素,适用于经中弱效类固醇治疗效果不佳的病症的短期疗程。 用于头皮对激素应答的皮肤病,例如:银屑病、难治性皮肤病

basic drug:

盐酸特比萘芬涂膜剂

prescription type:Rx

medical indications:非医保

specification::1%(4g:40mg)

status::待申报

indications::用于15岁及15岁以上青少年和成人由皮肤癣菌如毛癣菌(红色毛癣菌、须癣毛癣菌、疣状毛癣菌、紫色毛癣菌)、犬小孢子菌和絮状表皮癣菌引起的足癣。

basic drug:

卡泊三醇倍他米松软膏

prescription type:Rx

medical indications:医保乙类

specification::15g:卡泊三醇0.75mg与倍他米松7.5mg

status::待申报

indications::主要用于适合局部治疗的稳定性斑块状银屑病。

basic drug:

曲安奈德益康唑乳膏

prescription type:OTC

medical indications:医保乙类

specification::15g:硝酸益康唑0.15g与曲安奈德15mg 30g:硝酸益康唑0.3g与曲安奈德30mg

status::待申报

indications::1.伴有真菌感染或有真菌感染倾向的皮炎、湿疹; 2.由皮肤癣菌、酵母菌和霉菌所致的炎症性皮肤真菌病,如手足癣、体癣、股癣、花斑癣; 3.尿布性皮炎; 4.念珠菌性口角炎。 5.甲沟炎; 6.由真菌、细菌所致的皮肤混合感染。

basic drug:

非那雄胺喷雾剂

prescription type:Rx

medical indications:非医保

specification::18ml:40.95mg,每瓶180喷,每喷含非那雄胺114μg

status::待申报

indications::本品适用于18至41岁男性轻度至中度男性型秃发(雄激素性秃发)的局部外用治疗,以促进头发生长并防止继续脱发。

basic drug:

卡泊三醇软膏

prescription type:Rx

medical indications:医保乙类

specification::0.005%(15g:0.75mg) 0.005%(30g:1.5mg)

status::待申报

indications:: 用于寻常型银屑病的局部治疗。

basic drug:

利多卡因凝胶贴膏

prescription type:Rx

medical indications:医保乙类

specification::每贴(14.0cm×10.0cm)含膏体14g,含利多卡因700mg

status::待申报

indications::于缓解带状疱疹后遗神经痛;糖尿病性周围神经病理性疼痛。用于无破损的皮肤。

basic drug:

克拉考特酮乳膏

prescription type:Rx

medical indications:非医保

specification::1%(10g:0.1g) 1%(30g:0.3g)

status::待申报

indications::12岁及以上患者寻常痤疮的局部治疗。

basic drug:

妥洛特罗贴剂

prescription type:Rx

medical indications:非医保

specification::1mg/贴 2mg/贴

status::待申报

indications::用于缓解支气管哮喘、急性支气管炎、慢性支气管炎、肺气肿等气道阻塞性疾病所致的呼吸困难等症状。

basic drug:

罗替高汀贴片

prescription type:Rx

medical indications:非医保

specification::4.5mg/10cm2(释药量2mg/24h)

status::待申报

indications::本品适用于早期特发性帕金森病症状及体征的单药治疗(不与左旋多巴联用),或与左旋多巴联合用于病程中的各个阶段,直至疾病晚期左旋多巴的疗效减退、不稳定或出现波动时(剂末现象或“开关”现象)

basic drug:

地奈德软膏

prescription type:Rx

medical indications:非医保

specification::0.05%(15g:7.5mg)

status::待申报

indications::用于缓解皮质类固醇反应性皮肤病的炎症和瘙痒。

basic drug:

酮洛芬喷雾剂

prescription type:Rx

medical indications:非医保

specification::10%(12.5ml:1.25g) 10%(25ml:2.5g)

status::待申报

indications::用于缓解因拉伤、扭伤、扭曲和挫伤引起的软组织疼痛和发炎症状。

basic drug:

奥昔布宁透皮贴剂

prescription type:Rx

medical indications:非医保

specification::36mg/39cm2(释药量3.9mg/24hr)

status::待申报

indications::适用于伴有急迫性尿失禁、尿急、尿频症状的膀胱过度活动症的治疗

basic drug:

复方肝素钠尿囊素凝胶

prescription type:Rx

medical indications:非医保

specification::20g/支

status::待申报

indications::增生性瘢痕,瘢痕疙瘩,继发于手术、截肢、烧伤及其它意外后产生的活动受限及影响美观的瘢痕;挛缩性瘢痕如杜普伊特伦挛缩症、外伤引起的肌腱挛缩等;瘢痕性狭窄(萎缩性瘢痕)。

basic drug:

磺胺嘧啶银乳膏

prescription type:OTC

medical indications:医保甲类

specification::25g/支

status::待申报

indications::本品用于预防或治疗Ⅱ、Ⅲ度烧伤继发创面感染,包括对该药呈现敏感的肠杆菌科细菌、铜绿假单胞菌、金黄色葡萄球菌、肠球菌属,念珠菌等真菌所致者。

basic drug:

夫西地酸钠软膏

prescription type:Rx

medical indications:医保乙类

specification::2%(15g:0.3g)

status::待申报

indications::本品用于治疗由葡萄球菌、链球菌、极小棒状杆菌及其它对夫西地酸钠敏感细菌引起的皮肤感染。主要的适应症包括:脓疱疮、疖、汗腺炎、创伤感染、

basic drug:

Improved New Drugs

Improved Drug R&D Services

Focusing on redesign of existing high-value products, we innovate dosage-form strategies to improve treatment adherence and efficacy, and help clients build value-enhancing registration pathways and supporting capabilities.

Dosage Form Improvement & Optimization

Innovating dosage forms for existing drugs to improve patient compliance and medication convenience, and address the limitations of original formulations.

Formulation & Process Upgrade

Optimizing formulation composition and manufacturing processes to enhance product quality stability, reduce production costs, and improve large-scale manufacturing capacity.

Comprehensive Quality System

Establishing a complete quality control system covering raw material screening, intermediate control, and finished product testing to ensure product safety and efficacy.

Regulatory Submission

Providing professional registration strategy consulting and dossier preparation to help clients complete drug registration approval and accelerate product launch.

Innovative Drugs

Innovative Drug R&D Services

Starting from unmet clinical needs, we coordinate drug design, formulation development, and registration dossiers to help innovations move into the next stage.

Dosage Form Improvement & Optimization

Innovating dosage forms for existing drugs to improve patient compliance and medication convenience, and address the limitations of original formulations.

Formulation & Process Upgrade

Optimizing formulation composition and manufacturing processes to enhance product quality stability, reduce production costs, and improve large-scale manufacturing capacity.

Comprehensive Quality System

Establishing a complete quality control system covering raw material screening, intermediate control, and finished product testing to ensure product safety and efficacy.

Regulatory Submission

Providing professional registration strategy consulting and dossier preparation to help clients complete drug registration approval and accelerate product launch.