ChemWerth Inc DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

ChemWerth Names New CEO

18 Jun 2024

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Supply Chain Security If Your API Supply Is Important

05 Sep 2023

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PharmaTech Outlook Names ChemWerth as a Top Drug Discovery of 2023

24 May 2023

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DATA COMPILATION
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DIGITAL CONTENT

1 INTERVIEW #SpeakPharma, 1 VLOG #PharmaReel, 9 CORPORATE CONTENT #SupplierSpotlight, 32 NEWS #PharmaBuzz

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1 INTERVIEW #SpeakPharma
1 VLOG #PharmaReel
9 CORPORATE CONTENT #SupplierSpotlight
32 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

118 All APIs, 50 USDMF, 3 CEP/COS, 4 VMF, 99 Listed APIs

118 All APIs
50 USDMF
3 CEP/COS
4 VMF
99 Listed APIs

KEY PRODUCTS

Amphotericin B, Bivalirudin, Clevidipine, Epinastine Hydrochloride, Esmolol Hydrochloride, Fosaprepitant, Foscarnet Sodium, Isavuconazonium Sulfate, Lanreotide Acetate, Lufenuron, Melengestrol Acetate, Milbemycin Oxime, Milrinone, Nelarabine, Nitenpyram, Pergolide Mesylate, Ropivacaine Hydrochloride, Tiagabine Hydrochloride, Vancomycin Hydrochloride, Ziprasidone Hydrochloride, Ziprasidone Mesylate

SERVICES

Sales, Marketing, Registration

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Sales, Marketing, Registration

INSPECTIONS & REGISTRATIONS

9 FDA, 1 GDUFA

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9 FDA
1 GDUFA

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

About

Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs to regulated markets worldwide and has exclusive partnerships for new product development, compliance support and secure supply chain logistics. ChemWerth has access to over 500 APIs and more than 30 manufacturing facilities in the US, Europe, India and China. ChemWerth acts as a regulatory agent for over 25 FDA-approved facilities and sells more than 100 products. It has established its presence in 38 countries. In 2020, ChemWerth filed its 500th DMF with the FDA.

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17-20 March, 2025

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Industry Trade Show

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25-29 January, 2025

Orlando, FL
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03-05 February, 2025

Amelia Island

CONTACT DETAILS

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Country

U.S.A

Address

1764 Litchfield Turnpike Woodbridge, CT 06525

Telephone

+1 2033877794

jon.moore@chemwerth.com

Website

https://chemwerth.com/

https://www.linkedin.com/company/chemwerth-inc/

YouTube

http://www.youtube.com/@ChemWerth

Digital content

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INTERVIEW #SpeakPharma

“We are diversifying by expanding our manufacturing partnerships in China & India”

This week, SpeakPharma interviews Peter Werth, President and CEO of ChemWerth, a full-service generic drug development and supply firm that is celebrating its 40th year in business. On this milestone anniversary, Werth discusses the drugmaker’s plans to expand its manufacturing partnerships in China and India. These investments will further diversify its supply and portfolio, help develop new generic APIs, mitigate the risk of supply chain disruptions, and position ChemWerth to meet the increasing global demand for generic pharmaceuticals, says Werth.With ChemWerth turning 40, what are your thoughts on the company’s journey?We have had an interesting journey thus far. After being founded in 1983, we filed our first Drug Master File (DMF) with the US Food and Drug Administration (FDA) in 1987. We have come a long way since then, having established ourselves as specialists in product selection and development, analytical and regulatory services, as well as project management.Today, we are a leading supplier of generic active pharmaceutical ingredients (APIs) for human and animal health markets worldwide, with a presence in 38 countries. We have access to over 500 APIs from more than 30 manufacturing facilities worldwide. We also act as a regulatory agent for more than 25 facilities approved by the FDA in the US, Europe, India, and China. We have partnerships in several countries and sell more than 100 products worldwide.The year 2020 was a landmark year for us, as we filed our 500th DMF with the FDA. It strengthened our position as one of the world leaders in filing DMFs. Our average review cycle for DMF filings is just 0.79, which is much lower than the industry average of 2.5 cycles. This allows our customers to reach the market much faster, which in turn gives them a substantial competitive advantage over their competitors.With our reputation for supplying reliable, high-quality, non-infringing APIs at competitive prices, we have earned the trust of some of the largest generic pharmaceutical companies. Our continued growth and success are the result of our commitment to quality, our exceptional regulatory services, and our ability to adapt to changes in the pharmaceutical industry.In this year of our 40th anniversary, we’re entering an exciting period of growth. We are expanding our manufacturing footprint worldwide.Can you elaborate on these expansion plans?We have decided to invest millions of dollars in expanding our manufacturing partnerships in China and India. This will help us diversify our portfolio as well as our supply chain.Through our investments in our joint-venture facilities in India and China, we want to show our commitment towards delivering affordable medicines to patients all around the world. This expansion will also help us develop new generic APIs, mitigate the risk of supply chain disruptions, and meet the increasing demand for generic medicines worldwide.All our partner manufacturers that currently produce steroid, hormone and veterinary products and large-volume APIs and small-molecule inhibitors will benefit from the new investments. We will also create new jobs for highly skilled workers such as scientists, engineers, and manufacturing personnel.In addition to hiring employees, these investments will cover training that is required to raise compliance and quality to current good manufacturing practice (CGMP) standards and will be used to purchase new equipment.What’s the growth rate of the global generic drug market? How is ChemWerth planning to capitalize on this growth?The global generic drugs market is growing at a healthy pace. According to Precedence Research, a company that provides strategic market insights, the global market for generic drugs is poised to grow at a compounded annual growth rate (CAGR) of 5.4 percent, growing from US$ 439.37 billion in 2022 to US$ 670.82 billion by 2030. There are several factors contributing to this growth, such as the low cost of generics, expiration of patents of branded drugs, and increasing prevalence of chronic diseases.The pandemic led to supply chain disruptions that created drug shortages worldwide. How did ChemWerth mitigate the risk of supply chain disruptions?Yes, the pandemic was marked by supply chain disruptions that drove demand to unprecedented highs. During those days, ChemWerth relied on its experience and expertise in working with the FDA in order to gain necessary approvals and get the products on the market quickly. Our experienced team worked tirelessly to ensure that the supply of essential drugs was maintained, new drugs were developed to address emerging needs, and compliance remained at a high level.We monitored the global supply chain very closely, developed contingency plans, and diversified our manufacturing partnerships to reduce the risk of supply chain disruptions. As a result of these efforts, we successfully met the increased demand for pharmaceuticals during the pandemic and continued to deliver high-quality, affordable drugs to patients worldwide.At ChemWerth, we have a highly experienced team of regulatory and compliance experts who work closely with the FDA to ensure successful DMF approvals. We are proud of our track record of routinely gaining DMF approvals on the first pass. This places us among the best-in-class companies that are in the 12 percent approval group.In the future too, we intend to work on mitigating supply chain disruptions and provide high-quality generic pharmaceutical products to patients worldwide.

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