Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.

Start Date29 Apr 2025

Sponsor / Collaborator

The General Hospital Corp.

[+1]

CTRI/2024/12/077576

/ Not yet recruitingPhase 2IIT

Pilot exploratory clinical study to evaluate the safety and efficacy of SPONDYGON P50 tablet in the management of Spondylosis - NIL

Start Date17 Dec 2024

Sponsor / Collaborator-

IRCT20241107063630N1

/ RecruitingPhase 2/3IIT

Comparison of maternal and neonatal outcomes of two methods of administering prophylactic antibiotics: ampicillin and azithromycin versus ampicillin and cefazolin in premature rupture of membranes

Start Date10 Dec 2024

Sponsor / Collaborator

Isfahan University of Medical Sciences

100 Clinical Results associated with Ampicillin

100 Translational Medicine associated with Ampicillin

100 Patents (Medical) associated with Ampicillin

66,552

Literatures (Medical) associated with Ampicillin

31 Dec 2025·Sustainable Environment

A review on the occurrence of antibiotic-resistant bacteria found in abattoir effluent from resource-limited settings: The necessity of a robust One Health framework

Author: Dinginya, Lawrance ; Jambwa, Prosper ; Majuru, Chenai Sipiwe ; Chari, Tawanda Ashley ; Machakwa, Jairus ; Gufe, Claudious ; Mahlangu, Precious ; Marowero, Sheunesu Theo ; Kadungure, Tafadzwa

A review.Abattoirs discharge untreated waste into surrounding bodies of water and the environment, which is extremely harmful to public health.Bacteria that cause disease, especially those resistant to antibiotics, may be present in these wastes.This review was carried out to provide a comprehensive overview of antibiotic-resistant microbes discovered in slaughterhouse wastes in resource-limited settings.Relevant research studies focussing on bacteria isolated from abattoir effluents in resource-limited settings and AMR patterns were searched on Google Scholar, PubMed, Web of Science, and African journals online.The studies showed that numerous bacteria were detected, such as Salmonella spp., Bacillus spp.,Shigella spp.,Escherichia coli, Pseudomonas aeruginosa, Citrobacter freundii, Proteus spp.,Streptococcus spp.,Yersinia spp. and Staphylococcus aureus.Several of these isolates were resistant to multiple antibiotics, including Penicillin, Vancomycin, Clindamycin, Erythromycin, Tetracycline, Ampicillin, Linezolid, Gentamycin, Ciprofloxacin, Ampicillin, Ceftriaxone, Imipenem, Cefotaxime, Chloramphenicol, Trimethoprim-sulfamethoxazole, Piperacillin-Tazobactam, Ceftazidime, Imipenem, and Meropenem.Lack of proper waste management practices due to financial constraints is the major cause of a high prevalence of resistant bacterial strains in abattoir effluents in resource-limited settings.Given the critical role that the environment plays in the spread and maintenance of antibiotic-resistant microorganisms, public health systems must strengthen One Health National Action plans applicable to abattoir effluents to successfully combat antibiotic resistance.

31 Dec 2025·Emerging Microbes & Infections

Identification of host genetic factors modulating β-lactam resistance in Escherichia coli harbouring plasmid-borne β-lactamase through transposon-sequencing

Article

Author: Bell, Travis ; Lee, Kihyun ; Jeong, Jeongyun ; Lee, Changhan ; Bardwell, James C A ; Kim, Hyunhee

Since β-lactam antibiotics are widely used, emergence of bacteria with resistance to them poses a significant threat to society. In particular, acquisition of genes encoding β-lactamase, an enzyme that degrades β-lactam antibiotics, has been a major contributing factor in the emergence of bacteria that are resistant to β-lactam antibiotics. However, relatively few genetic targets for killing these resistant bacteria have been identified to date. Here, we used a systematic approach called transposon-sequencing (Tn-Seq), to screen the Escherichia coli genome for host genetic factors that, when mutated, affect resistance to ampicillin, one of the β-lactam antibiotics, in a strain carrying a plasmid that encodes β-lactamase. This approach enabled not just the isolation of genes previously known to affect β-lactam resistance, but the additional loci skp, gshA, phoPQ and ypfN. Individual mutations in these genes modestly but consistently affected antibiotic resistance. We have identified that these genes are not only implicated in β-lactam resistance by itself but also play a crucial role in conditions associated with the expression of β-lactamase. GshA and phoPQ appear to contribute to β-lactam resistance by regulating membrane integrity. Notably, the overexpression of the uncharacterized membrane-associated protein, ypfN, has been shown to significantly enhance β-lactam resistance. We applied the genes identified from the screening into Salmonella Typhimurium and Pseudomonas aeruginosa strains, both critical human pathogens with antibiotic resistance, and observed their significant impact on β-lactam resistance. Therefore, these genes can potentially be utilized as therapeutic targets to control the survival of β-lactamase-producing bacteria.

01 Oct 2025·TALANTA

Smartphone-integrated ratiometric colorimetric aptasensor for visual detection of ampicillin residue in animal-derived food samples

Article

Author: Solanki, Pratima R ; Sajwan, Reena K

The antibiotic residue in food accelerates bacteria's resistance process that is responsible for serious health issues. A smartphone-integrated ratiometric colorimetric aptasensor has been developed for ampicillin (AMP) detection in milk and egg samples. The sensing phenomenon utilizes the optical and color-changing properties of gold nanoparticles (AuNPs) and specific aptamer with higher affinity towards AMP for its selective detection. The aptasensor shows linear response with AMP concentration 0.06-9.9 μM with a lower detection limit (LOD) of 45.0 nM. The smartphone-integrated color analyzer application was used to identify the solution's red, green, and blue (RGB) color intensity and calculate the G/R ratio of color intensities in the presence of AMP. Aptasensor show linear response with AMP concentration (0-6.6 μM), with a LOD of 53.0 nM. The sensor's results were further validated with liquid chromatography and mass spectroscopy techniques (LC-MS), showing that the developed sensor is suitable for food monitoring and safety applications.

News (Medical) associated with Ampicillin

21 Apr 2025

·www.globenewswire.com

Basilea reports presentation of new data for fosmanogepix, isavuconazole (Cresemba®) and ceftobiprole (Zevtera®) at ESCMID Global 2025

April 16, 2025, Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today scientific presentations on Basilea’s clinical-stage novel antifungal fosmanogepix given at ESCMID Global 2025, the annual meeting of the European Society of Clinical Microbiology and Infectious Diseases, which took place from April 11 to 15, 2025 in Vienna, Austria. Further presentations covered the antifungal isavuconazole (Cresemba®) and the antibiotic ceftobiprole (Zevtera®). Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “Invasive fungal infections are an increasing global health problem and novel antifungals are urgently needed. To date more than 250 patients suffering from difficult-to-treat invasive fungal infections have received fosmanogepix via expanded access. The data presented at ESCMID highlight the potential of fosmanogepix as a life-saving treatment option in severe fungal infections, based on the results from a large cohort of patients with invasive fusariosis, as well as from patients with mucormycosis, who received fosmanogepix via expanded access. We look forward to the start of our second phase 3 study with fosmanogepix covering a broad range of mold infections, including aspergillosis, fusariosis and mucormycosis.” More than 250 patients from 11 countries with serious or life-threatening invasive fungal infections, who progressed on antifungal standard-of-care treatment, experienced treatment-limiting toxicities, or had infections with resistant fungal pathogens, received fosmanogepix via expanded access to date (NCT06433128). As presented at ESCMID, treatment with fosmanogepix resulted in favorable response rates of 70% or higher in patients with invasive fusariosis or mucormycosis and it was tolerated for long treatment durations. Further presentations reported on the activity of fosmanogepix against diverse yeast and mold species collected as part of a worldwide surveillance program. — Presentation IPT13: Fosmanogepix – a novel clinical phase 3 stage antifungal agent – M. Engelhardt — Presentation O0419: Fosmanogepix expanded access in patients withFusariuminfections – S. Dadwal, A. Baluch, J. Dickter, J. R. Newman, M. H. Nguyen, R. Weihe, H. Schlamm, L. Ostrosky-Zeichner — Poster P4164: Fosmanogepix expanded access case series in patients with mucormycosis – A. Puing, A. Kaur, Y. J. Lee, P.Chang, A. Koff, D. Tyungu, M. Oldham, M. Shaughnessy, A. Tande, H. Schlamm, J. Maertens — Poster E0237:Activity of manogepix against a worldwide collection of mould isolates from 2023–M. Winkler, S. Edeker, A. Klauer, P. R. Rhomberg, M. Castanheira — Poster P2891:Activity of manogepix against a worldwide collection of yeast isolates from 2023–M. Winkler, S. Edeker, A. Klauer, P. R. Rhomberg, M. Castanheira — Poster P2944: Deciphering Connections between Isavuconazole (ISAV) Drug Exposures and Responses Among Different Infections: Mucorales – L. Kovanda, A. Desai — Poster P2945: Deciphering Connections Between Isavuconazole Drug Exposures and Responses Among Different Infections: Dimorphic Fungi/Mould/Other Filamentous Fungi and Mixed Infections – A. Desai, L. Kovanda — Poster P2946: Deciphering Connections Between Isavuconazole Drug Exposures and Responses Among Different Infections: Invasive Candidiasis – L. Kovanda, A. Desai — Poster E0050: Enhancing Isavuconazole Pharmacokinetics: A Comprehensive Population (PPK) Model from Three Phase 3 Trials and Covariate Exploration – A. Desai, L. Kovanda — Poster E0055: High-dose isavuconazole therapy is well-tolerated and significantly improves survival in a fruit fly model of invasive mucormycosis – S. Wurster, N. D. Albert, N. P. Wiederhold, R. E. Lewis, D. P. Kontoyiannis Ceftobiprole (Zevtera) data presented at ESCMID Global 2025 — Poster E0792: Ceftobiprole alone versus in combination with ampicillin against borderline penicillin-resistant, vancomycin-resistant Enterococcus faecalis – O. Funk, I. Khan, J. Li, J. Cusumano Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections.1 A phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis is ongoing.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the US Food and Drug Administration for seven separate indications, and is designated as a Qualified Infectious Disease Product (QIDP). This project has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration of Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company. Cresemba, with the active ingredient isavuconazole, is an intravenous (i.v.) and oral azole antifungal. In the 27 European Union member states, as well as in Iceland, Liechtenstein and Norway, isavuconazole is approved for patients aged from 1 year of age and older for the treatment of invasive aspergillosis and for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate.3 Isavuconazole is also approved in the United States (US)4 and several additional countries in Europe and beyond, including the United Kingdom5, the Middle East and North Africa region, the Asia Pacific region, China and Japan.6 It has orphan drug designation in the US, Europe and Australia for its approved indications. Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria.7 In several countries in Europe and beyond, the brand is currently approved and marketed as Zevtera® and Mabelio® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP).7 In the United States, ZEVTERA® is indicated for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).8 Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). References K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239 Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis (FAST-IC): ClinicalTrials.gov identifier: NCT05421858 European Public Assessment Report (EPAR) Cresemba: https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: April 15, 2025] Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: April 15, 2025] Summary of Product Characteristics (SmPC) Cresemba: https://www.medicines.org.uk/emc/search?q=cresemba [Accessed: April 15, 2025] The registration status and approved indications may vary from country to country. Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: April 15, 2025] The content above comes from the network. if any infringement, please contact us to modify.

Orphan DrugClinical ResultDrug ApprovalFast Track

03 Dec 2024

·www.echemi.com

Zhejiang Anglikang Invests 79.91 Million for 4,105 Tons of Key Antibiotic Raw Material Production

Recently, Zhejiang Anglikang Pharmaceutical Co., Ltd. has completed the filing and public announcement for a project to produce 4,105 tons of D(-)-Hydroxyphenylglycine Methyl Ester and 1,230 tons of D(-)-Phenylglycine Hydrochloride. The planned investment for this project is 79.91 million yuan, aimed at utilizing the company's existing land resources to build new production facilities, production lines, and supporting ancillary facilities, with a total construction area expected to be 2,900 square meters. The project will employ advanced synthetic process technology and acquire key production equipment such as reactors and condensers. Upon completion, the project is expected to achieve an annual production capacity of 4,015 tons (dry weight) of D(-)-Hydroxyphenylglycine Methyl Ester and 1,230 tons (dry weight) of D(-)-Phenylglycine Hydrochloride, with an anticipated annual output value of 300 million yuan and tax contributions of 20 million yuan. By-products will include 20% hydrochloric acid (5,686.92 tons/year), ammonium sulfate (4,114.2 tons/year), and ammonium chloride (1,191.8 tons/year). D-Hydroxyphenylglycine Methyl Ester is an important raw material used in the enzymatic production of β-lactam antibiotics such as amoxicillin, cefuroxime axetil, cefaclor, and cefepime. According to previous environmental impact assessment reports, Zhejiang Anglikang Pharmaceutical Co., Ltd.'s project to produce 8,000 tons of amoxicillin and 2,000 tons of ampicillin plans to invest 300 million yuan and is expected to have an annual production capacity of 8,000 tons of amoxicillin and 2,000 tons of ampicillin upon completion, with a by-product of ammonium chloride at 3,164.68 tons/year. The current project can be seen as a further extension of the industrial chain. Zhejiang Anglikang Pharmaceutical Co., Ltd. is a modern pharmaceutical enterprise integrating the research, development, production, and sales of pharmaceutical intermediates, active pharmaceutical ingredients, and drug formulations, focusing on cardiovascular, oral cephalosporin, nephrology, and anesthetics. According to the company's latest financial report, in the first three quarters of the year, it achieved operating revenue of 1.122 billion yuan, a year-on-year decrease of 5.51%; the net profit attributable to the parent company was 49.93 million yuan, a year-on-year decrease of 54.52%; and the net profit after deducting non-recurring gains and losses was 39.91 million yuan, a year-on-year decrease of 54.33%.

Financial Statement

27 Nov 2024

·www.echemi.com

Lyfius Pharma Invests 25 Billion Rupees to Build the World's Largest Penicillin G Factory

Lyfius Pharma Pvt Ltd, a manufacturer of penicillin G, announced the launch of its state-of-the-art manufacturing facility in Kakinada, Andhra Pradesh, on October 29th. The company has invested 25 billion rupees in the plant, which has an annual production capacity of 15,000 tons, under the Production Linked Incentive (PLI) scheme. The facility was inaugurated online by Prime Minister Narendra Modi, with the presence of several Indian ministers, including Chemicals and Fertilizers Minister Jagat Prakash Nadda, Labour and Employment Minister Mansukh Mandaviya, and others. Lyfius Pharma's director, MV Rama Krishna, highlighted the significance of the Pen-G factory's launch as a milestone in strengthening local production and reducing reliance on imported key drug components. The investment underscores the company's commitment to the government's vision of "Atmanirbhar Bharat" (Self-Reliant India), aiming to establish India as a global pharmaceutical manufacturing hub. The company expects commercial production to accelerate in the fiscal year 2025, enhancing domestic output of key starting materials (KSM), drug intermediates (DI), and active pharmaceutical ingredients (API). Lyfius Pharma, a subsidiary of Aurobindo Pharma, operates the advanced facility in Andhra Pradesh, which is one of India's largest fermentation-based antibiotic intermediate plants, featuring large-capacity fermenters and automated starch and glucose plants. The project feasibility report outlines the production of 2,000 tons/year of 7-ACA, 15,000 tons/year of penicillin G, 198,000 tons/year of glucose, and 4,200 tons/year of 6-APA, with co-line products including 1,800 tons/year of amoxicillin trihydrate (enzyme method) and 1,800 tons/year of ampicillin trihydrate (enzyme method). Aurobindo Pharma's Q2FY2025 financial results show an 8.0% year-over-year increase in revenue to 77.96 billion rupees, with an EBITDA of 19.54 billion rupees before research and development, a profit margin of 25.1%, and a net profit of 8.17 billion rupees, up 8.6%. The company's performance indicates positive growth trends, particularly in Europe and growth markets, despite a 22.8% decline in ARV (antiretroviral) business revenue. The API business maintained stable revenue at 11.56 billion rupees, contributing 14.8% to total revenue.

Financial Statement

100 Deals associated with Ampicillin

External Link

KEGG	Wiki	ATC	Drug Bank
D02119	Ampicillin	J01CA01 S01AA19	DB00415

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bacterial Infections	Japan	Meiji Seika Pharma Co., Ltd.	27 Aug 1965

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03060473 (TREAT, CTgov)	Phase 3	Preterm Premature Rupture of the Membranes	21	Amoxicillin+Azithromycin+Ampicillin (Azithromycin)	dmruwvimue(ezneicoavd) = wrowixuioo xkrzxlmktn (nkdzykympf, oybnzemqvg - evmlvtsgzs) View more	-	25 Jun 2024
				Amoxicillin+Ampicillin+Erythromycin (Erythromycin)	dmruwvimue(ezneicoavd) = nebvuxovsb xkrzxlmktn (nkdzykympf, itkrarserg - ynmqlbcoto) View more
NCT02579161 (CTgov)	Phase 3	Kidney Calculi	98	Fluoroquinolones+cephalosporins+Gentamicin+Ampicillin+Clindamycin (Antibiotics for a 24 Hour Period)	jnrwigemud = yxustuopuz zfrdcjadac (uxrslylpie, dblwyzuwmn - hgjwijbhru) View more	-	14 Mar 2023
				Fluoroquinolones+cephalosporins+Gentamicin+Ampicillin+Clindamycin (Continued Antibiotics)	jnrwigemud = uroorjabdn zfrdcjadac (uxrslylpie, zuoggnavjq - zcdoemfhda) View more
NCT02477423 (CTgov)	Not Applicable	Enterocolitis, Necrotizing \| Obstetric Labor, Premature	27	Gentamicins+Ampicillin (Randomized & Blinded - Receiving Antibiotics)	nmntfwwdnt(pazvjinhlj) = uwddjolfkl bwaghkfifb (keyqvcedvb, 5.3) View more	-	03 Sep 2020
				Placebo (Randomized & Blinded - Receiving Placebo)	nmntfwwdnt(pazvjinhlj) = gpyfnlrbqs bwaghkfifb (keyqvcedvb, 6.9) View more
NCT02384200 (CTgov)	Phase 4	Kidney Calculi \| Urinary Tract Infections	86	nitrofurantoin monohydrate+gentamicin+ceftriaxone+ampicillin+Vancomycin (Antibiotic)	rxeymitpjk = wtqablnzdg pnloyslffr (drkrobbgdz, ngmvikuhyf - vctpkruqjq) View more	-	22 Aug 2019
				gentamicin+ceftriaxone+ampicillin+Vancomycin (No Preoperative Oral Antibiotics)	rxeymitpjk = ihgnjhdctc pnloyslffr (drkrobbgdz, wqthaekmhm - ukctjptdnr) View more
NCT01994993 (SCAMP, CTgov)	Phase 2/3	Complicated intra-abdominal infection	260	gentamicin+metronidazole+Ampicillin (Group 1)	zknjewgxuf = izpeqdplir nrmhjlkllm (phvucsfqtn, itndubdien - whuwtynlwf) View more	-	27 Feb 2018
				gentamicin+ampicillin+clindamycin (Group 2)	zknjewgxuf = usyktsmyim nrmhjlkllm (phvucsfqtn, jyggfprjtv - nonpsybbau) View more
NCT00879190 (CTgov)	Phase 2/3	Chorioamnionitis	92	Unasyn (Unasyn (Ampicillin/Sulbactam))	ainllzvntq = rkxmgjpisx yjsnlbynde (nuudzspobz, xrcvkkstbs - hlcuypmymv) View more	-	15 Mar 2017
				gentamicin+Ampicillin (Ampicillin/Gentamicin)	ainllzvntq = wstpjladrn yjsnlbynde (nuudzspobz, eupnsmqlxx - vcbaoqlzax) View more
IAS2004	Not Applicable	Chorioamnionitis	1,570	Active treatment (metronidazole 250 mg TID/erythromycin 500 mg TID)	ymdhncfrst(pfofioqzgq) = uaykqvtiib iwpezwljnt (ldwhxagwew )	-	01 Jan 2004
				Placebo	ymdhncfrst(pfofioqzgq) = aheeccqzke iwpezwljnt (ldwhxagwew )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Ampicillin

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation