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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: 13868

COMPANY BIO #AboutSupplier

View Sharp's clinical trial supply & contract pharmaceutical packaging services for injectables and oral dosage forms on PharmaCompass.

View Sharp's clinical trial supply & contract pharmaceutical packaging services for injectables and oral dosage forms on PharmaCompass. What is pharmaceutical contract packaging and how is Sharp a reliable packaging partner for the pharmaceutical and biotech industries? Pharmaceutical packaging can be defined as a set of operations including filling, sealing, packaging, and labeling of semi-finished or finished products. Pharma packaging is an economical means to present, preserve, identify, provide information, maintain product integrity, and ensure stability. It also plays a crucial role in the transportation of sensitive and strictly controlled products. Pharmaceutical contract packaging refers to packaging that is executed and supplied by a licensed third-party service provider that comprises both initial packaging and repackaging. These contract packaging service providers may offer clinical and commercial packaging solutions for pharmaceutical products. Pharmaceutical contract packaging organizations are well-equipped to offer a comprehensive range of primary, secondary, and tertiary packaging solutions. Primary packaging surrounds the pharmaceutical formulation and includes bottles, blisterings, pouches, sachets, tubes, auto-injector pens, etc. Whereas secondary packaging offers further external protection and includes artwork design, labeling for parenteral and injectables, child-resistant and compliance prompting packaging, etc. Additionally, tertiary packaging is used during transportation to absorb physical impacts, moisture, and dust and includes cardboard boxes, stretch wraps, shrink films, and wooden and plastic pallets. Sharp is a leading contract packaging organizations that offer pharmaceutical packaging services among others. It has more than 70 years of experience in pharmaceutical clinical packaging, clinical trial supply services, and small-scale sterile manufacturing. Sharp has more than 2,000 employees who work in its state-of-the-art GMP facilities in the US, UK, Belgium, and the Netherlands. Sharp, offers contract manufacturing and packaging services and support from phase I clinical trial supplies to commercial launch and lifecycle management to its pharmaceutical and biotechnology partners across the world. It has deep expertise in clinical trial packaging and labeling along with a skilled global design team that utilizes cutting-edge software and technology ensuring patient-friendly and differentiated packaging for drug products. Apart from this, Sharp is also a reliable partner for sourcing packaging material and offers integrated pharmaceutical packaging and labeling services along with over-encapsulation of oral solids and the production of placebo capsules for study blinding. Sharp is a contract packaging organization that offers commercial packaging services including contract blister packaging services, bottle packaging, sachet packaging, injectable packaging, and other solid dose packaging solutions. Additionally, it offers clinical packaging and labeling solutions such as clinical trial material packaging, clinical trial packaging and labeling, clinical trial logistics and packaging, and clinical trial supply services, or clinical supplies. Its clinical and commercial packaging services are outlined below: Clinical Packaging Solutions Sharps clinical packaging solutions encompass primary packaging and labeling and secondary packaging. Its pharmaceutical primary packaging offers reliable clinical packaging services, clinical supply chain services, primary packaging solutions, and cold-chain secondary packaging and labeling at 2-8°C, -20°C, and even at -70°C. Sharp also provides reliable clinical pharma packaging services and labeling, secondary packaging solutions, pharmaceutical clinical packaging and labeling solutions along with expertise and capabilities in handling cold-chain pharmaceutical labeling and packaging from 2-8°C to -70°C. Commercial Packaging Solutions For more than 65 years, Sharp has been providing a full range of commercial primary and secondary packaging solutions, blister packaging, and contract manufacturing and packaging services for pharmaceutical oral solid dosage forms. It offers contract blister packaging services and bottle packaging for pharmaceutical drug products. Apart from this Sharp provides pharma packaging contract services for small and large-volume batch sizes of injectables. It offers pharmaceutical packaging services for cold chain storage, packaging in temperature- and light-controlled environments, serialization, and customized distribution. Additionally, Sharp is involved in the pharma packaging of oral solids, liquids, and semi-solids. Moreover, Sharp is a premier commercial packaging service provider for high-value, low-volume gene therapy. It also offers pharmaceutical packaging services, expertise, and powerful technology that facilitates product serialization and aggregation. Therefore, Sharp’s pharma packaging contract services, spanning from clinical supplies to commercial include pharma clinical trial material manufacturing, clinical primary packaging services, clinical secondary packaging solutions, clinical trial packaging and labeling, and clinical trial logistics and packaging. Furthermore, Sharp’s contract manufacturing and packaging services encompass commercial pharma packaging solutions and labeling and supply services. Consequently, all the aforementioned offerings position Sharp as a one-stop-shop contract pharmaceutical packaging service provider for clinical and commercial scales. How does Sharp address challenges related to clinical labeling and secondary packaging? Sharp has over 70 years of experience and is a pioneer in clinical trial supply services and pharmaceutical packaging. Dedicated to the right-first-time principle, Sharp is a reliable partner for secondary packaging and clinical pharmaceutical labeling and packaging. It offers a wide range of quick, scalable clinical trial packaging services and labeling and packaging solutions in all formats, with capabilities spanning the complete lifespan of investigational medicinal products (IMPs). Moreover, Sharp can also address challenges related to packaging and labeling and offers pharmaceutical packaging and labeling services and clinical packaging and labeling services to its clients. Additionally, its clinical packaging and labeling solutions also include in-house auxiliary variable data printing outsourced booklet labels, client-supplied randomization fully supported, and annex 13 compliant and 21 CFR Part 11 compliant PRISYM software for label design. Sharp's pharmaceutical packaging and labeling services include single and multi-panel labels and booklets, 2D barcoding capabilities, randomized and open, 128 barcoding. It also offers regulatory and translation services, sequentially numbered, variable text, code break, and randomized generation among other clinical packaging and labeling solutions. Sharp is a leader in providing pharmaceutical clinical packaging, contract packaging services, and labeling and supply services in compliance with strict regulatory guidelines. It has special pharma packaging and labeling expertise and capabilities for packaging drug products. Sharp addresses various challenges related to pharma packaging and labeling which includes: Sharp can provide cold-chain pharmaceutical labeling and packaging from 2-8°C to -70°C for drug products that need low temperatures for their transportation and storage. Sharp can support the secondary packaging for most complex drug candidates, such as controlled substance packaging (DEA schedule I-V), and has the capabilities to scale up to commercial supplies. Its design and logistics staff can also assist with the challenges of blinding products and syringes for clinical trial services. Sharp does this by providing annex 13 compliant and 21 CFR Part 11 compliant PRISYM software for label design, client-supplied randomization fully supported, and in-house auxiliary variable data printing outsourced booklet labels. With issues related to timely delivery and efficient labeling, Sharp provides pharmaceutical labeling and packaging solutions by using Scan assembly technology and Interactive Response Technologies (IRT), storage, and distribution. To overcome the label readability issues for clients worldwide, Sharp designs and prints multilingual clinical labels. Therefore, Sharp acts as a one-stop-shop packaging organization that provides pharmaceutical contract packaging services, clinical primary packaging services, primary and secondary clinical packaging, and labeling and supply services to its clients worldwide. What range of packaging design and kitting services does Sharp offer? Sharp is a market leader in the design and delivery of primary and secondary packaging. Due to its structural, graphic, and design engineers as well as its understanding of supply chain and regulatory issues, Sharp excels in pharmaceutical packaging. Sharp has years of experience in creating cutting-edge pharma packaging solutions. It is skilled in brand creation, modifying current artwork, marketing research, FDA filing standards, 3D rendering, senior, child-friendly, or child-resistant design, and labeling and supply services. Sharp's global design team provides the creativity and accuracy required to design highly functional and compliant primary and secondary commercial and clinical pharma packaging services. Sharp offers a wide range of design services and pharmaceutical packaging solutions using the latest tools and technologies to guarantee premium and user-friendly product packaging. Additionally, it provides structural and graphic design development for quick launch and regular upgrades for commercial artwork. Sharp’s wide range of packaging design services for pharmaceutical products includes: Artwork Design Services: Sharp can provide pharma packaging contract services including customized artwork as per specific markets from initial mock-ups to product registration. Packaging Samples: Sharp’s contract pharmaceutical packaging services can create production-quality models for use in marketing presentations, human factor research, and photography that closely match the commercial package. Tray Design: Sharp precisely assesses product components to create a tray design that best suits the drug. 3D Printing: Sharp can rapidly confirm that all product components fit by using its technology to create 3D printed prototypes of trays and other packaging component designs. Shipper and Pallet Design: The structural designers at Sharp develop pallet layouts and shippers based on finished items to guarantee drug safety during distribution and storage. CR/SF Compliant Design and Testing: Sharp offers pharmaceutical contract packaging services and can determine the level of toxicity in child-friendly packaging. Various structural design services offered by Sharp include end-user interactions and compliance, child-resistant, senior-friendly (CR/SF) design, tamper evident features, multiple-component kitting requirements, and sustainable or specified materials. Additionally, Sharp’s graphic design capabilities include serialization artwork, brand identity, complete package graphics, product and package illustrations, and late-stage customization. Sharp’s broad range of tailored kitting options for medical devices, pharmaceuticals, and biotechnology calls for the packaging of multiple components into a single, self-contained unit. The design team at Sharp offers commercial packaging solutions and helps clients create a kit that best meets the end-user needs and product specifications. Its kitting services include labeling, tray packing, and boxing with comprehensive verification inspection to ensure the highest level of quality. How does Sharp manage the packaging of sterile formulations to ensure product integrity? Sharp has almost seven decades of packaging experience and it provides pharmaceutical packaging solutions for sterile and non-sterile formulations while maintaining the integrity and quality of products. It offers contract pharmaceutical packaging services and package design services from its US and EU facilities for injectables containing both small and large-volume batch sizes. For product launch and sample programs, its international design team works with clients to provide pharma packaging solutions and determine the optimal vial, prefilled syringe, and autoinjector packaging options. Through its partnership with Berkshire Sterile Manufacturing (BSM), Sharp also offers small-scale isolator-based sterile fill-finish options. It specializes in pharmaceutical clinical packaging and commercial packaging in cold chain storage, packaging in temperature and light-controlled environments, and specialty distribution for injectable drug products. It also supports multi-country launches from the US and EU. Sharp has experience in parenteral and injectable format labeling and packaging such as vials, autoinjectors, syringes, and pens. Its specialized commercial and clinical services for injectables and parenterals include primary and secondary labeling of vials, IV bags, pre-filled syringes, and IV bottles in ambient, cold and ultra-cold environments, custom label generation, kitting, serialization and aggregation, and storage and distribution. Some of Sharp’s sterile packaging capabilities for injectable drug products include: Vial Labeling and Packaging: Sharp has decades of packaging experience and offers pharmaceutical packaging and labeling services for vials. Its contract packaging services include an automated visual inspection of labeling, tray and carton packing, cartoning of single and multipacks, tamper-evident solutions, cold-chain storage (2-8°C), and ultra-low temperature freezer banks (-20°C/-70°C). In addition to these services, Sharp provides package design, kitting, and segregated suites to handle highly potent APIs (HPAPI), cytotoxins, hormones, serialization and aggregation, and specialty distribution. Autoinjector and Pen Assembly, Labeling, and Packaging: Sharp excels in managing the complexities related to autoinjector or pen device labeling and packaging from its US and EU facilities. Moreover, its YpsoMate autoinjector device delivers a high level of technical accuracy required for the assembly of prefilled syringes into YpsoMate autoinjectors. Sharp’s experts also offer clinical trial packaging services and specialize in managing the challenges related to clinical trial logistics and packaging of biological formulations. Pre-Filled Syringe Assembly, Labeling, and Packaging: Sharp is a leader in the assembly, labeling, and packaging of pre-filled syringes and safety devices. It provides customized commercial and clinical pharma packaging services for both small and large-volume batch sizes for injectables. Small Scale Sterile Fill-Finish: Sharp partners with Berkshire Sterile Manufacturing (BSM) and offers high-quality, manufacturing, packaging, and distribution solutions for flexible fillers, BSM fills vials, cartridges, syringes, and lyophilization. Gene Therapy Clinical and Commercial Packaging: Sharp has over 70 years of experience in packaging complex pharmaceuticals such as low-volume, high-value gene therapies. Sharp is also engineered to provide demand-led supply commercial and clinical services including batch sizes as small as 1 vial, or packaging, labeling, and distribution in cold, ultra-cold, or cryogenic conditions. Sharp also has dedicated facilities in Bethlehem, PA, US, Heerenveen, and the Netherlands for handling gene therapies. These facilities are equipped with HEPA air handling systems, controlled temperature, humidity and dew point, full-sized -80°C freezer banks in dedicated production suites, constant monitoring of time-out-of-refrigeration, and specific freeze-thaw cycles. These facilities help in providing clinical trial packaging services and clinical secondary packaging solutions along with commercial packaging of sterile formulations. What range of pharmaceutical packaging solutions does Sharp offer for solid and liquid drug products? With a history spanning more than 70 years, Sharp is a pioneer in providing pharmaceutical packaging services that include primary and secondary packaging of solid, liquid, and semi-solid drug products for clinical and commercial scales from its state-of-the-art facilities. Sharp offers innovative and economical clinical packaging services for investigational medicinal products (IMP). It also supports the packaging of various dosage forms including bottling of solid formulations, and thermo and cold forming blister packaging for oral solids. Sharp also supports the packaging of powder and OSDs in sachets and pouches, oral and transdermal films in strips, and injectables in vials, syringes, and cartridges. Moreover, it is also involved in the packaging of semi-solids such as cream and ointment in tubes. Some of Sharp’s pharmaceutical packaging solutions for solid and liquid drug products are mentioned below: Bottle Packaging for Solids and Semi-solids: Sharp provides pharma packaging contract services for bottle packaging that include component sourcing, carton printing and in-line cartoning or bundling, comprehensive onsite engineering and validation support, serialization and aggregation, and strict quality control for packaged drugs. Sharp also offers high-quality nitrogen flush bottles and bottle packaging for moisture and oxygen-sensitive drugs. Blister Packaging for Oral Solids: Sharp provides various blister packaging solutions including thermoform and cold form blisters, patient packs, hospital unit dose packs, wallet cards, child-resistant lidding, sustainable foil and blister materials, and multiple products per blister. Apart from this, Sharp’s contract blister packaging services also involve multi-color foil printing, in-house tooling design and fabrication, polymer laminates (Aclar, PVC/PVDC, etc.) heat-seal coating resins, and automated visual inspection. Pouches and Sachets for Solids and Transdermal Patches (Primary and Secondary Packaging Services): Sharp has expertise in pouch and sachet packaging filled with solid dose, powder, thin film, and transdermal patch drug products. Sharp’s solid dose packaging solutions offer considerable pouch and sachet packaging backed by quality operations and project management knowledge. Sharp is home to a sizable assemblage of form, fill, and seal technologies. Based on decades of practical expertise, Sharp uses a wide range of innovative film structure materials, such as coated papers, high-barrier foils, and polymer laminates, and offers pharma packaging contract services. It also can support the production of multiple dosage forms for pharmaceutical products. Oral Thin Film and Transdermal Patches: Sharp provides primary and secondary packaging services for oral thin films and transdermal patches. Sharp specializes in die-cutting and pouching sublingual and oral dissolvable films, and transdermal drug delivery systems, and offers specialized pharmaceutical packaging services through quality procedures. It utilizes the most up-to-date solid dose packaging solutions and processes to safely package and safeguard specialty drug products. Sharp’s oral thin film and transdermal patch capabilities include highly accurate dosing by die-cutting laminated products to any size and shape, in-line printing of drug info, bar codes, lot number, expiration date, serialization with optical character verification (OCV), etc. Therefore, Sharp is a pharmaceutical contract packaging organization that offers clinical services, cold chain packaging, clinical packaging and labeling, and commercial packaging. Its pharmaceutical contract packaging service also encompasses primary and secondary clinical and commercial packaging.

Impressions: 1837

NEWS #PharmaBuzz

Sharp Joins the UN Global Compact Initiative

30 Sep 2024

// PRESS RELEASE

Berkshire Sterile Manufacturing Appoints New President

28 May 2024

// PRESS RELEASE

Sharp Services Expands In Pennsylvania To Boost Sterile Injectable Market Growth

06 May 2024

// PRESS RELEASE

"3 Key Trends" with Rob Feltz

01 May 2024

// CONTRACT PHARMA

Sharp joins the Science Based Targets initiative (SBTi) to set greenhouse gas emissions reduction targets

23 Jan 2024

// PRESS RELEASE

Sharp acquires Berkshire Sterile Manufacturing

05 Oct 2023

// 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

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Drug Product Manufacturing

Discover their expertise for :

Capsule

01

CLINICAL SUPPLY OF CAPSULES

U.S.A

Sharp provides clinical manufacturing services for solid, semi-solid & liquid dosage forms including capsules, tablets, suspensions, creams, ointments, etc.

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

Pharma Service : Drug Product Manufacturing

Sharp

Category : Capsule

Sub Category : Clinical Supply

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

Pharma Service : Drug Product Manufacturing

CLINICAL SUPPLY OF CAPSULES

Sharp provides clinical manufacturing services for solid, semi-solid & liquid dosage forms including capsules, tablets, suspensions, creams, ointments, etc.

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Suspension

01

SUSPENSION CLINICAL MANUFACTURING

U.S.A

Sharp provides clinical manufacturing services for solid, semi-solid and liquid dosage forms including suspensions, tablets (immediate and controlled release), powders, emulsions, etc.

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

Pharma Service : Drug Product Manufacturing

Sharp

Category : Suspension

Sub Category : Overview

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

Pharma Service : Drug Product Manufacturing

SUSPENSION CLINICAL MANUFACTURING

Sharp provides clinical manufacturing services for solid, semi-solid and liquid dosage forms including suspensions, tablets (immediate and controlled release), powders, emulsions, etc.

Suspension Clinical Manufacturing Services

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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

01

TABLET CLINICAL MANUFACTURING SERVICES

U.S.A

Sharp is engaged in clinical manufacturing services for ethical, over-the-counter products including tablets (immediate and controlled release), powders, capsules, etc.

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

Pharma Service : Drug Product Manufacturing

Sharp

Category : Tablet

Sub Category : Controlled / Immediate / Modified Release

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

Pharma Service : Drug Product Manufacturing

TABLET CLINICAL MANUFACTURING SERVICES

Sharp is engaged in clinical manufacturing services for ethical, over-the-counter products including tablets (immediate and controlled release), powders, capsules, etc.

02

CLINICAL SUPPLY OF TABLETS

U.S.A

Sharp provides clinical manufacturing services for various dosage forms such as controlled-release tablets, immediate-release tablets, capsules, liquids, creams, ointments, etc.

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

Pharma Service : Drug Product Manufacturing

Sharp

Category : Tablet

Sub Category : Clinical Supply

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

Pharma Service : Drug Product Manufacturing

CLINICAL SUPPLY OF TABLETS

Sharp provides clinical manufacturing services for various dosage forms such as controlled-release tablets, immediate-release tablets, capsules, liquids, creams, ointments, etc.

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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

01

CLINICAL SUPPLY FORMULATION DEVELOPMENT

U.S.A

Sharp is a global leader in clinical supply chain services 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 : API & Drug Product Development

Sharp

Category : Formulation Development

Sub Category : Clinical Supply

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

Pharma Service : API & Drug Product Development

CLINICAL SUPPLY FORMULATION DEVELOPMENT

02

TABLET FORMULATION DEVELOPMENT

U.S.A

Sharp offers formulation development of tablets (immediate and controlled release), powders, phase I-IV formulation development and reformulations, etc.

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

Pharma Service : API & Drug Product Development

Sharp

Category : Formulation Development

Sub Category : Tablet

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

Pharma Service : API & Drug Product Development

TABLET FORMULATION DEVELOPMENT

Sharp offers formulation development of tablets (immediate and controlled release), powders, phase I-IV formulation development and reformulations, etc.

03

FORMULATION DEVELOPMENT OF SUSPENSIONS

U.S.A

Sharp provides formulation of suspensions, tablets (immediate and controlled release), powders, phase I-IV formulation development and reformulations, etc.

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

Pharma Service : API & Drug Product Development

Sharp

Category : Formulation Development

Sub Category : Suspension

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

Pharma Service : API & Drug Product Development

FORMULATION DEVELOPMENT OF SUSPENSIONS

Sharp provides formulation of suspensions, tablets (immediate and controlled release), powders, phase I-IV formulation development and reformulations, etc.

04

DEVELOPMENT OF CREAMS & OINTMENTS

U.S.A

Sharp is engaged in the formulation development of solid, semi-solid and liquid dosage forms like creams, ointments, lotions, suspensions, emulsions, etc.

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

Pharma Service : API & Drug Product Development

Sharp

Category : Formulation Development

Sub Category : Cream / Gel / Lotion / Ointment

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

Pharma Service : API & Drug Product Development

DEVELOPMENT OF CREAMS & OINTMENTS

Sharp is engaged in the formulation development of solid, semi-solid and liquid dosage forms like creams, ointments, lotions, suspensions, emulsions, etc.