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Patient Centric Clinical Trial Services

Serialisation to Pharmaceutical Authentication & Patient Safety

ISO Certification

Belgium Site

UK Site

GMP Certificate 2022

Sharp Packaging US Supports Launch of Two Cancer Therapies

Capacity Expansion in the US & UK

Sharp Packaging Solutions Increasing Packaging Capacity by 30%

Sharp Selects Werum IT Solutions as Strategic MES Partners

Corporate Video

Serialisation Update

Sharp Partners with Domino for Serialisation Services

DATA COMPILATION #PharmaFlow

Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397 Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17 13 37 Taiwan 9 6 5 4 24 Switzerland 15 4 4 23 France 16 6 22 Japan 18 1 19 United Kingdom 12 1 2 15 Mexico 9 1 1 11 Ireland 5 5 1 11 Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years.

Impressions: 14788

COMPANY BIO #AboutSupplier

Sharp | Pharmaceutical Packaging | Contract Packaging

View Sharp's contract pharmaceutical packaging services, including primary packaging & secondary packaging services on PharmaCompass. How do Sharp’s capabilities and global expertise establish it as a leader in pharmaceutical packaging? Sharp has positioned itself as a leader in pharmaceutical packaging by offering end‑to‑end commercial solutions that span primary packaging services and secondary packaging services. With facilities strategically located in the US, UK, and EU, Sharp provides innovative, scalable pharma packaging solutions for a wide range of dosage forms, including oral solids and injectables Their expertise covers pharmaceutical packaging design, serialization, aggregation, and sustainable pharma packaging, enabling them to manage complex regulatory requirements while ensuring quality, safety, and efficiency. By integrating global expertise with advanced technologies, Sharp supports pharmaceutical and biotech clients from clinical stages through commercial launch, making them a trusted partner in contract packaging. Sharp offers an extensive range of formats from bottles, blisters, pouches, and sachets while specializing in complex requirements such as cold‑chain labeling, clinical trial blinding, and sterile manufacturing. This breadth allows Sharp to serve both small clinical batches and large‑scale commercial volumes with speed, flexibility, and reliability. By combining global reach, regulatory expertise, and technical versatility, Sharp delivers innovative, right‑first‑time solutions that reduce risk and accelerate market entry, reinforcing its reputation as a trusted provider of contract pharma packaging services, contract packaging, and both primary packaging services and secondary packaging services worldwide. How does Sharp ensure global serialization and aggregation compliance? Sharp is a leader in commercial packaging, clinical services, and sterile manufacturing with a heritage spanning more than 70 years. In the field of pharmaceutical packaging, Sharp ensures full compliance with global serialization and aggregation requirements by combining deep domain expertise and robust technologies for primary packaging and secondary packaging services. Their serialization practice dates back to 2007, and their team of specialists in engineering, design, quality, validation, and project management deliver reliable, regulatory‑compliant traceability across both primary packaging and secondary packaging operations. To manage the complexity of track‑and‑trace regulations, Sharp maintains a flexible, interoperable architecture that supports various regional frameworks. Powerful traceability systems integrated with pharmaceutical packaging lines apply unique serial numbers and manage aggregation data, ensuring every unit, case, and pallet is fully trackable. By applying proven, uniform methods across global sites, Sharp minimizes complexity and reduces implementation timelines for clients seeking pharmaceutical contract packaging services. Their scalable GMP facilities, serialization‑ready lines, and standardized vendor platforms reduce integration risks, simplify data exchange, and ensure consistent compliance across markets. In short, Sharp’s expertise in contract packaging, pharmaceutical packaging, and pharma packaging combined with decades of serialization leadership guarantees compliance and reliability. By embedding serialization and aggregation into every primary packaging and secondary packaging operation, Sharp strengthens supply chain visibility and establishes itself as a trusted partner in pharmaceutical contract packaging services worldwide. What are the key packaging challenges in the pharmaceutical industry, and how does Sharp address them? In the pharmaceutical packaging industry, pharma packaging faces multiple complex challenges from ensuring patient safety and regulatory compliance to optimizing logistics, sustainability, and usability. Sharp addresses these with specialized expertise and innovative solutions. Complex secondary packaging services design: Pharmaceutical Packaging formats like blister carding, tertiary trays, shipper design, and kitting involve a wide variety of materials and configurations. Sharp’s design team composed of structural engineers, graphic designers, and regulatory experts can navigate this complexity to deliver contract packaging that is both high‑quality and efficient. Sustainability and Protection: Pharmaceutical industry is increasingly adopting eco‑friendly materials, but many of these newer materials pose design and cost challenges. Sharp’s Sustainable Materials Innovation Group explores alternatives like recycled thermoform plastics, mono‑material cardboards, and biodegradable PaperFoam®, validating these for sterility and stability without compromising patient safety. Sharp also tackles challenges like global serialization and aggregation requirements, ensuring every unit is traceable and compliant with DSCSA and EU FMD standards. Their expertise in primary packaging services and secondary packaging services ensures reliability across formats. User‑friendly safety design: Designing packages that are both child‑resistant (CR) and senior‑friendly (SF) is particularly challenging. Sharp’s global design team addresses this by engineering compliant CR/SF packaging in accordance with standards like ISO 8317 and 16 CFR‑1700.20.They also run design iterations and testing, carefully balancing resistance for child safety with usability for older or physically challenged users. Sharp develops child‑resistant formats such as bottles and blister packs that comply with safety regulations yet are easy for adults to use, striking the right balance between protection and accessibility. Patient‑centric usability: Beyond resistance, Sharp prioritizes user experience. For example, in injectables, their designers have developed trays that maintain sterility while allowing easy, ergonomic removal of the device by patients including those with limited dexterity. Logistics and shipping risk: Ensuring that pharma packaging can withstand real‑world transportation is critical. Sharp conducts rigorous shipping studies, simulating vibration, impact, and environmental stress to make sure that pharmaceutical contract packaging services protect the product all the way to the patient.By combining innovation, compliance, and global expertise, Sharp strengthens its role as a trusted leader in contract pharma packaging services, pharma packaging, and pharmaceutical packaging worldwide. What quality systems and GMP standards does Sharp follow in its secondary packaging to ensure reliability and safety? Sharp maintains the highest standards of reliability and safety in its secondary packaging through a comprehensive Pharmaceutical Quality System (PQS) and a cloud-based Quality Management System (QMS) that ensures consistent document control, CAPA management, and process compliance across all its global facilities. Its GMP-certified sites in the US, EU, and UK are regularly inspected and follow validated procedures for vial labeling, cartoning, kitting, and serialization, ensuring adherence to international regulatory requirements. Every process is validated, monitored, and continuously improved to ensure pharma packaging integrity, patient safety, and compliance with international regulatory authorities such as the FDA, EMA, and MHRA By embedding GMP principles into both clinical packaging and commercial packaging, Sharp guarantees reliability and consistency at every stage. Their “right‑first‑time” approach, combined with employee accountability for quality, ensures medicines are packaged safely, traceably, and in full compliance with global standards, reinforcing Sharp’s role as a trusted partner in pharmaceutical packaging services. Sharp’s design and engineering teams work closely with quality and regulatory experts to integrate compliance, usability, and safety into every package. Child-resistant and senior-friendly features, correct component verification, and serialization are carefully embedded into the process. This multi-layered approach allows Sharp to deliver consistent, compliant, and high-quality contract packaging solutions that pharmaceutical companies can trust. By combining expertise in contract pharma packaging, commercial packaging, clinical packaging, and pharmaceutical packaging services, Sharp reinforces its reputation as a global leader in reliable and safe pharma packaging operations.

Impressions: 91

NEWS #PharmaBuzz

Sharp Appoints Samantha as General Counsel

01 Oct 2025

// PRESS RELEASE

Sharp invests $20 million in autoinjector & pen assembly lines

02 Sep 2025

// PRES RELEASE

Sharp's Emissions Reduction Targets Validated by Science Target

15 Jul 2025

// PRESS RELEASE

Berkshire Sterile Mfg, Rebrands to Sharp Sterile Manufacturing

18 Oct 2024

// PRESS RELEASE

Sharp Joins the UN Global Compact Initiative

30 Sep 2024

// PRESS RELEASE

Berkshire Sterile Manufacturing Appoints New President

28 May 2024

// PRESS RELEASE

Services

Discover the service capabilities from this company

Packaging

Discover their expertise for :

Design & Development

01

CLINICAL PACKAGING DESIGN

U.S.A

Sharp’s knowledge of regulatory and supply chain challenges makes them a market leader for pharmaceutical packaging, structural and graphic design. Its capabilities include packaging design services and cartoning of single and multipacks.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Design & Development

Sub Category : Overview

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

CLINICAL PACKAGING DESIGN

Capabilities
#ServicesBio

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Clinical Services

01

CLINICAL TRIAL SERVICES - PACKAGING

U.S.A

Sharp serves pharma and biotech clients by offering clinical trial services including clinical manufacturing, primary and secondary packaging solutions, storage and distribution, etc.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Clinical Services

Sub Category : Overview

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

CLINICAL TRIAL SERVICES - PACKAGING

Sharp serves pharma and biotech clients by offering clinical trial services including clinical manufacturing, primary and secondary packaging solutions, storage and distribution, etc.

02

CLINICAL LABELING & SECONDARY PACKAGING

U.S.A

Sharp’s clinical labeling expertise helps to efficiently package clinical trial IMP to suit patients from any region. With specialist capabilities in key areas, IT can support cold-chain labeling & packaging from 2-8°C to -70°C.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Clinical Services

Sub Category : Label

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

CLINICAL LABELING & SECONDARY PACKAGING

03

BOTTLE PACKAGING SERVICES

U.S.A

Sharp delivers a comprehensive suite of clinical primary packaging services that enable the delivery of high-quality investigational medicinal products (IMP) on time. It provides bottle filling for solid and semi-solid dosage forms.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Clinical Services

Sub Category : Bottle

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

BOTTLE PACKAGING SERVICES

04

PACKAGING FOR CONTROLLED SUBSTANCES

U.S.A

Sharp is engaged in primary & secondary packaging solutions including controlled substance packaging, pouching & powder filling, coldform & thermoform blistering, design engineering & support, etc.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Clinical Services

Sub Category : High Potent / Biologic / Controlled Substance

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

PACKAGING FOR CONTROLLED SUBSTANCES

Sharp is engaged in primary & secondary packaging solutions including controlled substance packaging, pouching & powder filling, coldform & thermoform blistering, design engineering & support, etc.

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Contract Services

01

CONTRACT PHARMA PACKAGING SERVICES

U.S.A

Sharp is a global leader in contract pharmaceutical packaging offering solutions and support to pharmaceutical and biotechnology clients from phase I trials all the way through to commercialization and rapid launch.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Contract Services

Sub Category : Overview

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

CONTRACT PHARMA PACKAGING SERVICES

02

PFS ASSEMBLY, LABELING & PACKAGING

U.S.A

Sharp is highly experienced in the contract pharmaceutical packaging, assembling, labelling and kitting of pre-filled syringes for many leading pharmaceutical packaging companies in the world.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Contract Services

Sub Category : Pre-Filled Syringe

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

PFS ASSEMBLY, LABELING & PACKAGING

Sharp is highly experienced in the contract pharmaceutical packaging, assembling, labelling and kitting of pre-filled syringes for many leading pharmaceutical packaging companies in the world.

Sharp PFS Assembly, Labeling & Packaging

03

BLISTER CONTRACT PACKAGING SERVICES

U.S.A

Sharp is a leader in blister packaging of pharmaceutical oral solid dose drugs for 70 years. It offers primary & secondary contract pharma packaging solutions including blister packaging (any configuration), cold form & thermoform blistering.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Contract Services

Sub Category : Blister

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

BLISTER CONTRACT PACKAGING SERVICES

04

SECONDARY PACKAGING SERVICES

U.S.A

Sharp provides expert pharmaceutical contract packaging services, including packaging design, labeling, kitting and serialization solutions to support its clients' complex packaging needs.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Contract Services

Sub Category : Secondary Packaging

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

SECONDARY PACKAGING SERVICES

Sharp provides expert pharmaceutical contract packaging services, including packaging design, labeling, kitting and serialization solutions to support its clients' complex packaging needs.

05

PHARMA SERIALIZATION & AGGREGATION

U.S.A

Sharp has both experience and expertise to design a vast range of solutions for your product. It provides pharmaceutical contract packaging services, including packaging design and serialization solutions to support your complex packaging needs.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Contract Services

Sub Category : Serialization Compliance

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

PHARMA SERIALIZATION & AGGREGATION

Pharmaceutical Serialization & Aggregation

06

HPAPI CONTRACT PACKAGING

U.S.A

Sharp provides advanced packaging services to the biotechnology industry, offering state-of-the-art vial labelling and packaging including highly potent APIs (HPAPI) such as cytotoxics and hormones.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Contract Services

Sub Category : High Potent / Biologic / Controlled Substance

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

HPAPI CONTRACT PACKAGING

Sharp provides advanced packaging services to the biotechnology industry, offering state-of-the-art vial labelling and packaging including highly potent APIs (HPAPI) such as cytotoxics and hormones.

07

VIAL CONTRACT PACKAGING

U.S.A

Sharp provides pharmaceutical & biotech vial labeling & packaging solutions from its US & EU facilities. It offers vial labelling and packaging services with capabilities including multiple vial labelling lines, in-line cartoning of labeled vials, etc.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Contract Services

Sub Category : Vial

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

VIAL CONTRACT PACKAGING

08

AUTOINJECTOR ASSEMBLY & PACKAGING

U.S.A

Sharp offers a comprehensive array of solutions for your autoinjector or pen device from our US and EU packaging facilities. It can engineer and run a dedicated line for your autoinjector or pen device.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Contract Services

Sub Category : Auto Injector / Pen

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

AUTOINJECTOR ASSEMBLY & PACKAGING

09

BOTTLE PACKAGING

U.S.A

Sharp provides deep expertise and flexibility in the delivery of pharmaceutical oral solid dose bottling and packaging services, it ensures the best packaging solution for your drug product.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

Sharp

Category : Contract Services

Sub Category : Bottle

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Packaging

BOTTLE PACKAGING

Sharp provides deep expertise and flexibility in the delivery of pharmaceutical oral solid dose bottling and packaging services, it ensures the best packaging solution for your drug product.

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Analytical

Discover their expertise for :

Analytical Method Development

01

CLINICAL ANALYTICAL & RESEARCH SERVICES

U.S.A

Sharp offers clinical trial services and develops analytical methods used throughout various phases of their clients’ drug development and manufacturing projects.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Analytical

Sharp

Category : Analytical Method Development

Sub Category : Method Development and Validation

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Analytical

CLINICAL ANALYTICAL & RESEARCH SERVICES

Sharp offers clinical trial services and develops analytical methods used throughout various phases of their clients’ drug development and manufacturing projects.

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Drug Product Manufacturing

Discover their expertise for :

Capsule

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Suspension

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Lyophilization

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Injectable / Parenteral

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Cream / Lotion / Ointment

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Liquid

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Tablet

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API & Drug Product Development

Discover their expertise for :

Preformulation & Material Science

01

CLINICAL PRE-FORMULATION SERVICES

U.S.A

Sharp provides pre-formulation services like physical properties and product characterisation, hygroscopicity studies, photostability of APIs, reverse engineering, etc.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : API & Drug Product Development

Sharp

Category : Preformulation & Material Science

Sub Category : Solid State Characterization

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : API & Drug Product Development

CLINICAL PRE-FORMULATION SERVICES

Sharp provides pre-formulation services like physical properties and product characterisation, hygroscopicity studies, photostability of APIs, reverse engineering, etc.

Capabilities
#ServicesBio

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Formulation Development

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Clinical Trials

Discover their expertise for :

Packaging & Logistics

01

CLINICAL TRIAL STORAGE & DISTRIBUTION

U.S.A

Sharp takes real pride in providing clinical storage and distribution services, making sure its clients' product gets to the right place at the right time in optimum condition.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Clinical Trials

Sharp

Category : Packaging & Logistics

Sub Category : Storage Solutions

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Clinical Trials

CLINICAL TRIAL STORAGE & DISTRIBUTION

Sharp takes real pride in providing clinical storage and distribution services, making sure its clients' product gets to the right place at the right time in optimum condition.

02

PHARMACEUTICAL COLD CHAIN SOLUTIONS

U.S.A

Sharp provides services including pre-qualified temperature-controlled packaging, chilled storage and distribution between 2ºC and 8ºC, frozen storage and distribution to -80ºC and controlled ambient storage and distribution between 15ºC and 25ºC.

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Clinical Trials

Sharp

Category : Packaging & Logistics

Sub Category : Cold Chain Solutions

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Pharma Service : Clinical Trials

PHARMACEUTICAL COLD CHAIN SOLUTIONS

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KEY SERVICES

TOP RANKED SUPPLIER FOR:

Primary Pharmaceutical Packaging Services

Inspections and registrations

Check the inspections & registration from this company

FDA

01 FDA Audited

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

District Decision : No Action Indicated

Inspection End Date : 2024-08-29

Sharp

City : Bethlehem

State : Pennsylvania

Country/Area : U.S.A

Zip : 18020

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2024-08-29

Product
Web Link

02 FDA Audited

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

District Decision : No Action Indicated

Inspection End Date : 2023-02-24

Sharp

City : Conshohocken

State : Pennsylvania

Country/Area : U.S.A

Zip : 19428

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2023-02-24

Product
Web Link

03 FDA Audited

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

District Decision : No Action Indicated

Inspection End Date : 2022-12-09

Sharp

City : Macungie

State : Pennsylvania

Country/Area : U.S.A

Zip : 18062

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2022-12-09

Product
Web Link

04 FDA Audited

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-09-02

Sharp

City : Bethlehem

State : Pennsylvania

Country/Area : U.S.A

Zip : 18020

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-09-02

Product
Web Link

05 FDA Audited

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-01-28

Sharp

City : Allentown

State : Pennsylvania

Country/Area : U.S.A

Zip : 18106

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-01-28

Product
Web Link

06 FDA Audited

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-08-30

Sharp

City : Bethlehem

State : Pennsylvania

Country/Area : U.S.A

Zip : 18020

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-08-30

Product
Web Link

07 FDA Audited

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-04-24

Sharp

City : Allentown

State : Pennsylvania

Country/Area : U.S.A

Zip : 18106

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-04-24

Product
Web Link

08 FDA Audited

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

District Decision : No Action Indicated

Inspection End Date : 2018-10-25

Sharp

City : Conshohocken

State : Pennsylvania

Country/Area : U.S.A

Zip : 19428

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2018-10-25

Product
Web Link

09 FDA Audited

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-08-16

Sharp

City : Macungie

State : Pennsylvania

Country/Area : U.S.A

Zip : 18062

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-08-16

Product
Web Link

10 FDA Audited

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

District Decision : No Action Indicated

Inspection End Date : 2018-08-13

Sharp

City : Allentown

State : Pennsylvania

Country/Area : U.S.A

Zip : 18106

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2018-08-13

Product
Web Link

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EDQM

01

GMP Certified

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Sharp

Type : GMP Certificates

Number : NL/H 22/204...

EudraGMDP Key : 148463

Country : U.S.A

Issue Date : 2022-06-14

Post Code :

NCA Ref : 165521766330...

City : Allentown

Product
Web Link

02

GMP Certified

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Sharp

Type : GMP Certificates

Number : UK MIA 1028...

EudraGMDP Key : 80059

Country : United Kingdom

Issue Date : 2020-03-11

Post Code :

NCA Ref : 18457585-SHA...

City : Tredegar

Product
Web Link

03

GMP Certified

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Sharp

Type : GMP Certificates

Number : UK MIA(IMP)...

EudraGMDP Key : 80579

Country : United Kingdom

Issue Date : 2020-03-02

Post Code :

NCA Ref : 18457585-SHA...

City : Tredegar

Product
Web Link

04

GMP Certified

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Sharp

Type : GMP Certificates

Number : UK MIA(IMP)...

EudraGMDP Key : 55410

Country : United Kingdom

Issue Date : 2019-03-29

Post Code :

NCA Ref : 18457585-SHA...

City : Tredegar

Product
Web Link

05

GMP Certified

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Sharp

Type : GMP Certificates

Number : DE_BY_05_GM...

EudraGMDP Key : 46332

Country : U.S.A

Issue Date : 2018-02-05

Post Code :

NCA Ref : 00021524

City : Allentown

Product
Web Link

06

GMP Certified

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Sharp

Type : GMP Certificates

Number : IT/GMP/E/13...

EudraGMDP Key : 39289

Country : U.S.A

Issue Date : 2016-12-22

Post Code :

NCA Ref : 1363-SHARP C...

City : Conshohocken

Product
Web Link

07

GMP Certified

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Inizio

Type : GMP Certificates

Number : 2015/9201/V...

EudraGMDP Key : 29437

Country : Ireland

Issue Date : 2015-06-04

Post Code : Dublin 24

NCA Ref : 114

City : Citywest

Product
Web Link

08

GMP Certified

Inizio

Type : GMP Certificates

Number : 2015/9201/I...

EudraGMDP Key : 29438

Country : Ireland

Issue Date : 2015-06-04

Post Code : Dublin 24

NCA Ref : W00052/00001...

City : Citywest

Product
Web Link

09

GMP Certified

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Sharp

Type : GMP Certificates

Number : DE_SH_01_GM...

EudraGMDP Key : 31465

Country : U.S.A

Issue Date : 2014-10-09

Post Code :

NCA Ref : 00021524

City : Allentown

Product
Web Link

10

GMP Certified

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Sharp

Type : GMP Certificates

Number : UK GMP 1040...

EudraGMDP Key : 15710

Country : U.S.A

Issue Date : 2012-09-25

Post Code :

NCA Ref : 54942-SHARP ...

City : PENNSYLVANIA

Product
Web Link

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GDUFA

01 GDUFA fees paid

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Paid in : 2025

Sharp

API Manufacturer :

FDF Manufacturer : FDF MANUFACTURE

Facility Name : Sharp Sterile Manufacturing LL...

Business Address : 480 Pleasant St Lee MA 01238...

FEI Number : 3012144557

Country : U.S.A

Paid in : 2025

Product
Web Link

02 GDUFA fees paid

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Paid in : 2025

Sharp

API Manufacturer :

FDF Manufacturer : FDF MANUFACTURE

Facility Name : Sharp Packaging Services, LLC

Business Address : 22-23 Carland Road Conshohoc...

FEI Number : 2518332

Country : U.S.A

Paid in : 2025

Product
Web Link

03 GDUFA fees paid

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Paid in : 2025

Sharp

API Manufacturer :

FDF Manufacturer : FDF MANUFACTURE

Facility Name : Sharp Packaging Services, LLC

Business Address : 7570 Industrial Park Way Mac...

FEI Number : 3009566827

Country : U.S.A

Paid in : 2025

Product
Web Link

04 GDUFA fees paid

USA

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

Paid in : 2025

Sharp

API Manufacturer :

FDF Manufacturer : FDF MANUFACTURE

Facility Name : Sharp Packaging Services, LLC

Business Address : 7451 Keebler Way Allentown P...

FEI Number : 3004161147

Country : U.S.A

Paid in : 2025

Product
Web Link