利格列汀/盐酸二甲双胍(Linagliptin/Metformin Hydrochloride) - 药物靶点：DPP-4 x PRKAB1_在研适应症：2型糖尿病_专利_临床

Comparative bioequivalence study of the Linagliptin 2.5 mg / Metformin 1000 mg tablets manufactured by Darman Yab Darou vs Trajentamet® tablets manufactured by Boehringer Ingelheim Pharmaceutical Company in healthy volunteers

开始日期2025-12-27

申办/合作机构-

NCT07763964

/ CompletedN/A

Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 100 mg/1000 mg in Healthy Subjects Under Feed Conditions.

Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study

开始日期2025-12-08

申办/合作机构

Adium Pharma SA

NCT07763951

/ CompletedN/A

Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 100 mg/1000 mg in Healthy Subjects Under Fast Conditions.

Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study

开始日期2025-12-03

申办/合作机构

Adium Pharma SA

100 项与利格列汀/盐酸二甲双胍相关的临床结果

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100 项与利格列汀/盐酸二甲双胍相关的转化医学

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100 项与利格列汀/盐酸二甲双胍相关的专利（医药）

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5

项与利格列汀/盐酸二甲双胍相关的文献（医药）

2019-01-01·Journal of pharmaceutical and biomedical analysis3区 · 医学

A validated LC-MS/MS method for simultaneous determination of linagliptin and metformin in spiked human plasma coupled with solid phase extraction: Application to a pharmacokinetic study in healthy volunteers

3区 · 医学

Article

作者: Abbas Moussa, Bahia ; Mahrouse, Marianne Alphonse ; Fawzy, Michael Gamal

Combination therapy has a pivotal role in type II diabetes mellitus management in patients unable to maintain normal glycemic level using metformin alone. Addition of linagliptin, dipeptidyl peptidase-IV inhibitor, to metformin improves glycemic control. This study is concerned with the development of an HPLC-MS/MS method for simultaneous quantification of linagliptin and metformin in spiked human plasma. The method was applied to evaluate the potential pharmacokinetic interactions between the cited drugs in healthy volunteers. Solid phase extraction was applied using Strata™ X cartridge. Separation was carried out on Symmetry^® C₁₈ column using methanol: 10 mM ammonium formate buffer (containing 0.2% formic acid) in a ratio of (95: 5, v/v) as mobile phase at flow rate 0.25 mL min^-1. Quantification was performed with multiple reaction monitoring in positive ionization mode. The monitored transitions were set at m/z 473.24 → 419.94, 130.14 → 60.18 and 340.27 → 116.07 for linagliptin, metformin and alogliptin (internal standard), respectively. The method was validated according to FDA guidelines. The method showed excellent linearity over concentration ranges 0.25-10 and 25-2000 ng mL^-1 for linagliptin and metformin, respectively. The validated HPLC-MS/MS method was successfully applied to pharmacokinetic study of linagliptin and metformin in healthy volunteers after oral administration of Jentadueto^® tablets.

2014-10-01·Drugs1区 · 医学

Linagliptin: An Update of Its Use in Patients with Type 2 Diabetes Mellitus

1区 · 医学

Review

作者: McKeage, Kate

Linagliptin (Trajenta(®), Tradjenta(®)) is a dipeptidyl peptidase (DPP)-4 inhibitor approved for the treatment of adults with type 2 diabetes mellitus in several countries. A fixed-dose combination of linagliptin/metformin (Jentadueto(®)) is also available. This article reviews the pharmacology, therapeutic efficacy and tolerability of linagliptin in the management of type 2 diabetes, with the aim of updating its place in therapy based on recently published data. In randomized, controlled trials, oral linagliptin 5 mg once daily (or 2.5 mg twice daily when combined with metformin) improved glycaemic control when used alone or in combination with other antidiabetic agents, including metformin, a sulfonylurea, thiazolidinedione or insulin. Improvements in glycaemic control were also shown in patients with renal impairment, including severe impairment, and the elderly (aged ≥70 years). Linagliptin is the first DPP-4 inhibitor to be eliminated primarily via a nonrenal route, enabling its use without dosage adjustment in patients with any degree of renal impairment. Linagliptin is generally well tolerated and, as with other DPP-4 inhibitors, it is associated with a low risk of hypoglycaemia and has no effect on bodyweight. Some data indicate that linagliptin may have beneficial effects on cardiovascular and renal safety profiles in patients with type 2 diabetes, but more data are needed. Meanwhile, the low risk of hypoglycaemia and the nonrenal route of elimination may provide important advantages for some patient groups, including elderly or renally impaired patients.

2013-09-01·Revue medicale de Liege

[Jentadueto, fixed combination of linagliptin plus metformin for the treatment of type 2 diabetes].

Review

作者: Scheen, A J ; Van Gaal, L F

In case of failure of metformin monotherapy, several pharmacological strategies may be considered for the treatment of type 2 diabetes. Among these, the addition of an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme, a medication commonly named as gliptin, is increasingly used because of two main advantages over sulfonylureas, i.e. the absence of both hypoglycaemia and weight gain. The combination of a gliptin and metformin further improves glycaemic control compared to either monotherapy, due to complementary mechanisms of action. Most patients with type 2 diabetes are treated every day with numerous drugs because of the presence of comorbidities so that poor drug compliance is a major concern in such a population. The use of fixed-dose combinations (FDCs) may improve compliance and, therefore, several gliptin-metformin FDCs are now available. The most recent one is Jentadueto, which combines linagliptin, a selective DPP-4 inhibitor without renal excretion, and metformin, the first-line antidiabetic compound. This FDC is commercialized with two dosages of metformin, i.e. 2.5 mg linagliptin/850 mg metformin and 2.5 mg linagliptin/1.000 mg metformin, and should be administered twice daily with meal.While linagliptin may be prescribed whatever the renal function, the use of FDC should take into account classical restrictions imposed by the presence of metformin.

82

项与利格列汀/盐酸二甲双胍相关的新闻（医药）

2026-08-12

·米内网

【突破】国内首个！华润双鹤1657万喜提重磅新品

精彩内容眼科“老药”有了新身份。8月12日，华润双鹤公告称，公司控股子公司中帅医药申报的3类仿制药乙酰唑胺缓释胶囊获批生产并视同过评，为国内首款获批预防或改善急性高山病的药品。乙酰唑胺属于碳酸酐酶抑制剂，其片剂剂型已在国内上市多年，适用于各种类型的青光眼，属于眼科领域的“老药”，2026年一季度在中国三大终端六大市场（统计范围详见本文末）的销售额增速超过30%。近日，中帅医药的乙酰唑胺缓释胶囊获批生产并视同过评，是国内首个获批的乙酰唑胺缓释剂型，拥有3年数据保护期（2029年8月3日）。截至公告日，公司针对该药品累计研发投入为1656.80万元(未经审计)。国内已获批上市的乙酰唑胺制剂产品来源：米内网一键检索值得一提的是，乙酰唑胺缓释胶囊是国内首款获批预防或改善急性高山病的药品。试验结果显示，与安慰剂组相比，用药组（乙酰唑胺缓释胶囊）急性高原病发生率显著降低，其中中重度急性高原病发生率下降14.6%。米内网数据显示，今年以来，华润双鹤有15个品种获批生产并视同过评，其中血液和造血系统药物有5个，神经系统药物、生殖泌尿系统和性激素类药物、消化系统及代谢药、心脑血管系统药物各有2个等。今年以来华润双鹤获批上市的品种来源：米内网中国申报进度（MED）数据库 15个品种中，不乏依折麦布片、复方醋酸钠林格注射液(钠钾镁钙葡萄糖注射液)等2025年在中国三大终端六大市场销售额超10亿元的大品种；以及黄体酮注射液(Ⅱ)、利格列汀二甲双胍片(Ⅱ)等2026年一季度销售额增速达三位数的潜力品种。此外，今年以来，华润双鹤有6个品种以新注册分类报产/报临床获受理。其中，口服用苯丁酸甘油酯、盐酸右哌甲酯片、普瑞巴林缓释片均暂无首仿（含剂型首仿）获批。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至8月12日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。

上市批准

2026-08-10

·adalvo.com

Adalvo Announces DCP Submission for Linagliptin and Metformin Fixed-Dose Combination Tablets

Extending the company's dossier list in one of the most commercially relevant oral diabetes therapies in the global generics market. Zug, Switzerland, 10 August 2026: Adalvo today announced the submission of its Decentralised Procedure (DCP) for its generic Linagliptin and Metformin fixed-dose combination (FDC) tablets. The filing builds on the recent DCP approval and marketing authorisation of Adalvo's Linagliptin 5mg film-coated tablet extending the company's dossier list in one of the most commercially relevant oral diabetes therapies in the global generics market. With one of the few generic's portfolios spanning both oral and injectable diabetes treatments, Adalvo is establishing itself as a leader in this space. Developed as a generic of Jentadueto®, the Linagliptin and Metformin fixed-dose combination is indicated for the treatment of type 2 diabetes mellitus in adults. Type 2 diabetes is one of the most urgent and fast-growing challenges in global healthcare. A 2025 report from the International Diabetes Federation estimates that 589 million adults of adults aged 20-79, 11.1% are living with diabetes, a figure projected to reach 853 million by 20501. Low- and middle-income countries carry 80% of the diabetes burden, and over half of those affected in these regions remain undiagnosed. As diagnostic coverage improves, patient numbers will rise sharply, driving significant demand for affordable oral therapies. According to IQVIA, the total addressable market for Linagliptin and Metformin was USD 393M as of 2025, and with type 2 diabetes cases set to keep rising, the commercial opportunity for licensing partners is substantial and growing. The submission reflects Adalvo's long-term investment in complex generics and its clearly defined intellectual property strategy. This submission reflects Adalvo's commitment to advancing high-quality, differentiated generic medicines and expanding future treatment options for patients through rigorous development and regulatory execution. Disclaimer: Products which are subject to patent protection are currently not offered or made available in countries where patents are in force. Jentadueto® is a registered trademark of Boehringer Ingelheim International GmbH.

2026-08-03

·中国中小企业河南网

福元医药亮了！

日前，福元医药2款产品糠酸莫米松乳膏（10g:10mg）、联苯苄唑溶液（30ml:0.3g）新增品规的补充申请获批，公司14个品种拟参与第十二批集采。2019年至今，福元医药已有79个重磅品种获批上市，94个产品获批过评（25个首家），累计18个品种国采中选。公司稳步推进“仿创结合”研发策略，3款创新药步入Ⅰ期临床及以上阶段，33款高端仿制药报产在审。斩获79个重磅品种，33款仿制药冲刺上市日前，福元医药公告称，其2款产品的补充申请获得批准——糠酸莫米松乳膏新增品规10g:10mg，联苯苄唑溶液新增品规30ml:0.3g。糠酸莫米松乳膏用于湿疹、神经性皮炎等，为国家基药、医保乙类药和OTC甲类品种；联苯苄唑溶液用于治疗皮肤真菌病，为国家医保乙类药、OTC乙类品种。其2025年在中国三大终端六大市场（统计范围详见本文末）销售额分别超8亿元和3亿元，为皮肤病用皮质激素制剂TOP2产品、皮肤病用抗真菌药TOP5产品。米内网数据显示，2019年至今，福元医药已成功斩获79个重磅品种（按产品名称统计，下同），包括阿卡波糖片、瑞舒伐他汀钙片、阿托伐他汀钙片、艾司奥美拉唑镁肠溶干混悬剂、替米沙坦氢氯噻嗪片、阿戈美拉汀片、艾拉莫德片、地屈孕酮片、乳果糖口服溶液、磷酸特地唑胺片等，进一步丰富公司产品线。截至目前，福元医药共有33款仿制药报产在审，其中，洛索洛芬钠贴剂、酮洛芬贴剂、阿达帕林过氧苯甲酰凝胶、佩玛贝特片、盐酸毛果芸香碱滴眼液等国内暂未有仿制药获批上市，利伐沙班口崩片、利格列汀二甲双胍缓释片、雌二醇片/雌二醇地屈孕酮片复合包装、泊沙康唑口服混悬液、戊酸雌二醇片等有望冲击国产第2家，甲磺酸溴隐亭片、罗替高汀贴片、对乙酰氨基酚布洛芬片、奈妥匹坦帕洛诺司琼胶囊、普罗布考片等有望冲击国产第3家。 94个过评产品太猛了，14个品种备战新国采福元医药持续开展高质量的仿制药一致性评价工作，目前已有94个产品过评/视同过评，其中2019年有6个，2020年有9个，2021年有8个，2022年有5个，2023年有9个，2024年有19个，2025年有22个，2026年至今有16个。过评产品数呈稳步攀升之势。从剂型上看，片剂为主力军，占比接近70%，胶囊剂和软膏剂各占约10%；按治疗大类统计，心脑血管系统药物、消化系统及代谢药在数量上遥遥领先，均有超20个产品在列，皮肤病用药以14个产品位居其后。 94个过评/视同过评产品中，有25个品种为首家过评（含同日过评），包括氯沙坦钾氢氯噻嗪片、盐酸文拉法辛缓释胶囊、富马酸贝达喹啉片、莫匹罗星软膏、达格列净片、盐酸特比萘芬喷雾剂、复方α-酮酸片、黄体酮软胶囊、磷酸特地唑胺片、替米沙坦氢氯噻嗪片、沙格列汀二甲双胍缓释片(Ⅰ)/(Ⅲ)、丙戊酸钠缓释片(Ⅰ)、美沙拉秦肠溶片、美阿沙坦钾片、丙酸氟替卡松乳膏等。同时，福元医药积极参与国家药品带量采购，累计有18个品种（不含续约）在已开展的十批化药集采中中选。其中，在中国公立医疗机构终端，公司的瑞格列奈片市场份额由2021年的8.19%增长至2026Q1的27.07%，格列齐特缓释片市场份额由2021年的23.71%增长至2026Q1的41.95%，盐酸文拉法辛缓释胶囊市场份额由2021年的15.62%增长至2026Q1的35.07%，依折麦布片市场份额由2022年的0.25%增长至2026Q1的24.97%等。 7月22日，国家药品联采办发布《第12批国家组织药品集中带量采购公告（第2号）》，开标时间拟定于7月31日。据统计，福元医药的14个品种有望参与第十二批集采。其中，地屈孕酮口服常释剂型、吡格列酮二甲双胍口服常释剂型、艾拉莫德口服常释剂型、氨氯地平贝那普利口服常释剂型均为2025年中国公立医疗机构终端销售额超10亿元的重磅品种。从企业格局上看，比索洛尔氨氯地平口服常释剂型、美阿沙坦口服常释剂型等竞争比较激烈，均有超20家满足条件；地奈德软膏剂则竞争较为缓和，目前仅7家满足条件。 “仿创结合”研发策略提速，1类新药瞄准1200亿市场在坚持打造首仿、快仿品牌优势，深化布局一致性评价工作的同时，福元医药还积极推进创新药研发，依托核酸技术平台开展多靶点药物研发，加快公司技术升级与战略转型，落实“仿创结合”的发展战略。为此，公司近年来不断加大研发投入，2021-2025年研发投入分别达1.8亿元、2.4亿元、3.5亿元、4.2亿元和4亿元，占营业收入的比例为6.33%、7.40%、10.58%、12.11%和11.51%，研发投入强度保持高位。米内网数据显示，福元医药目前有3款化药新药处于Ⅰ期临床及以上阶段，包括2款1类新药和1款2.3类改良型新药，均属于心脑血管系统药物。在中国三大终端六大市场，心脑血管系统化药2025年销售规模超1200亿元；2026Q1同比增长7.74%，从亚类格局上看，高血压用药和血脂调节剂占主导，市场份额分别达57.5%和21.63%。改良型新药奥美沙坦酯左氨氯地平片是一款复方降压药，由奥美沙坦和左氨氯地平组成，可通过双重机制协同降压，拟用于单药控制不佳的原发性高血压患者，或单药联合使用的患者，目前已步入Ⅲ期临床。 1类新药FY101注射液适用于高脂血症的治疗，给药途径为皮下注射，目前国内外尚无同类型同靶点产品获批上市，其Ⅰ期临床试验正稳步推进中，国内目标入组人数为62人。 1类新药FY103注射液适用于高血压的治疗，给药途径同为皮下注射，目前国内外尚无同类型同靶点产品获批上市。米内网数据显示，该新药于2026年3月首次获批临床，随后于今年4月便进入Ⅰ期临床，可谓是进展神速。资料来源：米内网数据库、公司官网及年报注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至7月23日，如有疏漏，欢迎指正！责任编辑：周艳珍

100 项与利格列汀/盐酸二甲双胍相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	A10BD11	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
2型糖尿病	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2012-01-30

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02084056 (CTgov)	临床1期	-	74	linagliptin+metformin (L+M 2000 Fasted)	餘鹽淵糧範構積淵壓鬱(築壓衊鹽構餘醖觸構觸) = 齋製艱壓獵願艱鬱廠鑰鏇範淵窪壓繭齋鑰夢顧 (鏇膚鹽蓋簾艱夢齋壓糧, 9.1) 更多	-	2016-08-04
				linagliptin+metformin (FDC 2000 Fasted)	餘鹽淵糧範構積淵壓鬱(築壓衊鹽構餘醖觸構觸) = 鹹鹽遞膚憲醖積簾簾淵鏇範淵窪壓繭齋鑰夢顧 (鏇膚鹽蓋簾艱夢齋壓糧, 9.1) 更多
NCT02084082 (CTgov)	临床1期	-	68	linagliptin+metformin (L+M 1000 Fasted)	範簾鹹廠製艱淵觸齋鏇(廠鏇鏇遞餘餘簾鏇廠鏇) = 遞顧蓋蓋鹹顧觸憲構廠襯製鹹遞襯選膚淵獵願 (餘廠餘顧齋艱衊糧鏇廠, 11.8) 更多	-	2016-08-04
				linagliptin+metformin XR (FDC 1000 Fasted)	範簾鹹廠製艱淵觸齋鏇(廠鏇鏇遞餘餘簾鏇廠鏇) = 鏇壓獵衊壓蓋糧餘顧鏇襯製鹹遞襯選膚淵獵願 (餘廠餘顧齋艱衊糧鏇廠, 11.8) 更多
NCT02121509 (CTgov)	临床1期	-	74	linagliptin+metformin (L+M 1500 Fasted)	製醖觸鏇糧壓構鏇蓋選(窪膚餘憲築醖鹽鏇製鑰) = 鹽淵襯鏇製壓範選壓繭願膚夢壓壓糧選糧遞夢 (襯齋築醖膚鹹觸憲艱築, 11.5) 更多	-	2016-08-04
				linagliptin+metformin (FDC 1500 Fasted)	製醖觸鏇糧壓構鏇蓋選(窪膚餘憲築醖鹽鏇製鑰) = 簾簾蓋壓簾製觸壓衊壓願膚夢壓壓糧選糧遞夢 (襯齋築醖膚鹹觸憲艱築, 11.5) 更多
NCT01708902 (EASD2015)	临床3期	2型糖尿病	733	Linagliptin 5 mg QD	餘餘襯遞製鹽繭襯鑰夢(壓鹽顧觸簾選網艱艱衊) = low across groups 築願範繭窪簾範艱鹹蓋 (艱蓋衊蓋積獵顧觸衊廠 ) 更多	积极	2015-09-17
				Metformin 500 mg BID
NCT01845077 (CTgov)	临床1期	-	72	linagliptin+metformin (FDC1000 Fasted)	築淵衊淵顧夢蓋艱積鏇(膚範醖構築構選鏇齋選) = 夢遞鏇廠鬱網積築鏇壓獵鹽蓋鑰網壓窪鬱範淵 (餘夢築窪糧夢膚製醖蓋, 8.0) 更多	-	2014-08-19
				linagliptin+metformin (L+M1000 Fasted)	築淵衊淵顧夢蓋艱積鏇(膚範醖構築構選鏇齋選) = 築齋構襯餘淵獵鹽鑰憲獵鹽蓋鑰網壓窪鬱範淵 (餘夢築窪糧夢膚製醖蓋, 8.0) 更多
NCT01581931 (CTgov)	临床1期	-	32	Met (Lina+Met Single Tablets)	製鏇簾餘衊鹹餘觸醖顧(觸淵膚夢顧遞憲壓選積) = 夢構夢醖獵蓋膚廠廠選積廠鬱糧糧壓窪繭窪簾 (簾鬱憲築築餘觸衊鬱築, 9.8) 更多	-	2013-08-20
				Met (Lina+Met FDC Tablet)	製鏇簾餘衊鹹餘觸醖顧(觸淵膚夢顧遞憲壓選積) = 鹽獵壓膚願艱衊鹹膚製積廠鬱糧糧壓窪繭窪簾 (簾鬱憲築築餘觸衊鬱築, 9.8) 更多
NCT01540487 (CTgov)	临床1期	-	48	Linagliptin+Metformin (Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet)	夢構齋鏇鏇獵遞餘醖廠(餘繭艱構膚獵壓淵壓鹹) = 鏇壓簾膚獵範積築積簾願築簾窪醖膚顧窪範齋 (艱獵醖醖夢範鹽繭選憲, 14.5) 更多	-	2013-08-06
				Linagliptin+Metformin (Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets)	夢構齋鏇鏇獵遞餘醖廠(餘繭艱構膚獵壓淵壓鹹) = 繭憲獵簾壓夢夢製鏇積願築簾窪醖膚顧窪範齋 (艱獵醖醖夢範鹽繭選憲, 15.3) 更多
NCT01383356 (CTgov)	临床1期	2型糖尿病	58	Met (Lina/Met 2.5mg/500mg)	夢齋簾築鏇願繭膚選顧(鏇鬱艱壓齋膚衊鬱製觸) = 糧願遞壓蓋繭蓋鹹選選衊糧壓衊蓋願鹽願鏇衊 (範鬱鹹餘獵鑰鏇遞壓餘, 262.45) 更多	-	2013-01-24
				Met (Lina 2.5mg Plus Met 500mg)	夢齋簾築鏇願繭膚選顧(鏇鬱艱壓齋膚衊鬱製觸) = 蓋範遞觸蓋夢製顧艱積衊糧壓衊蓋願鹽願鏇衊 (範鬱鹹餘獵鑰鏇遞壓餘, 189.44) 更多
NCT01216397 (CTgov)	临床1期	-	40	linagliptin+metformin (Standard Batch)	壓網構膚餘鹽觸衊製觸(艱窪醖積壓製遞獵遞簾) = 鬱鏇鑰鬱構簾廠齋簾廠夢積廠簾壓餘築積夢鏇 (醖範簾築觸憲遞壓觸鹽, 20.3) 更多	-	2012-04-25
				linagliptin+metformin (Side Batch)	壓網構膚餘鹽觸衊製觸(艱窪醖積壓製遞獵遞簾) = 構遞醖選糧製鹹築獵糧夢積廠簾壓餘築積夢鏇 (醖範簾築觸憲遞壓觸鹽, 20.3) 更多