API industry is facing serious headwinds that require re-strategizing business models

peter-werthThis week, we bring you another interesting interview with Peter J. Werth, President and Chief Executive Officer of ChemWerth, a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company providing current Good Manufacturing Practices (cGMP) quality APIs to the regulated markets. Werth talks about how complexities have increased in the last one year wherein the conversation on compliance has evolved from strictly GMP processes to data integrity and now Environmental Health and Safety (EHS). With the US Food and Drug Administration (FDA) publishing research for free, it is also becoming harder for generic manufacturers to find new products. Moreover, increasing costs mandate that API manufacturers put more efforts in product development so that the time to approval is considerably reduced. In light of these new challenges, Werth discusses the high standards and goals being set by his organization.

Read the interview on pharmacompass.com

“FDA’s enforcement actions are putting the global pharmaceutical supply chain at risk”

peter-werthPeter J. Werth, President and Chief Executive Officer of ChemWerth, a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company providing current Good Manufacturing Practices (cGMP) quality APIs to the regulated markets, shares his view on how the government inspections have evolved over the past years. The effect of the recent US Food and Drug Administration (US FDA) inspections is putting the global pharmaceutical supply chain in real danger. Excerpts from the interview.

Read the interview on pharmacompass.com

ChemWerth and Enoray announce that Enoray has passed second U.S. FDA inspection

July 2017: ChemWerth Inc. and Hubei Enoray Biopharmaceutical Co., Ltd. (Enoray) are pleased to announce that Enoray has passed their second U.S. FDA inspection in July, 2017 with no 483 issued. The FDA inspection focused on Heparin API. ChemWerth has worked closely with Enoray over the past three years, through extensive on-site training, audits, as well as providing sound technical support, to ensure that their operations are fully cGMP compliant. Enoray was established in 2010 and mainly produces FDA/EU grade Heparin, Enoxaparin, and other low molecular weight Heparins based on its own vertically integrated production operation from traceable porcine derived starting materials through API manufacturing in dedicated facilities. ChemWerth is Enoray’s U.S. Site Agent as well as its Regulatory Agent for multiple Drug Master Files (DMFs) including Heparin Crude, Heparin API, and Enoxaparin API.

Enoray Picture

What are the key criteria that make an API factory succeed in today’s market?

Opening remarks given by Ed Vanderbeck, COO, ChemWerth. 2 day cGMP training seminar in Shanghai, China.

November 3-4th, 2016.

ChemWerth has spent the last 35 years revising the answer to that question. Understand, it needs to be put into context in an industry that is constantly evolving. The answer we come up with today is much different than 5 years ago and will most likely much different in the next 5 years. However one theme has not changed. In-fact, it is becoming more important year after year: Compliance.

We should agree that without a compliance strategy, you may as well change industries. The reality is that the bar is always being raised, and will most certainly rise again. The question is do you have a foundational strategy in place that can adapt with the often changing regulatory landscape? Is your strategy reactive or proactive?

GDUFA 2 has just come out and the USFDA is focusing on Data Integrity. The CFDA has publically stated they will crack down on non-compliant factories while EDQM audits are focused almost entirely on processes. Our customers are now actively pursuing their own Environmental Health and Safety Audits and adopting a proactive approach.

We have seen more and more factories shut down, receive warning letters and under import alert over the last 18 months than ever before. This can be good or bad, depending upon where you stand on this issue, your commitment to compliance and how important the US and your domestic market is to your business.

The cost of drug development has increased dramatically when GDUFA introduced the need to run three exhibit batches. The Finished dosage companies are now spending 3x more for API than they did only two years ago. These companies want to have confidence in the factory they choose, knowing they will be able to meet the rigors of the new compliance standards.

With this in mind, the finished dosage companies – our customers – are now going to Audits with up to four people in many cases. Two people to run the typical 6 system type audit, one to evaluate DI and one to evaluate EHS. Many, like Amneal, Pfizer, Mylan, TEVA and Sandoz are running the audits prior to committing to the project – it is that important. This will trickle down to the smaller and medium sized companies as well. Why? Because they will realize the cost of not auditing the factory prior to starting a project is too high of a risk, costing time and money.

So, what does this mean to you? It comes down to simple mathematics. If you are a factory that commits to compliance, it will equate to more business. This is because most factories that do not commit to the compliance will be eliminated in the first round by the customers, with the remainder eventually receiving warning letters from the USFDA or shut down by the CFDA. This results in less factories supplying the market with API and more business for your company.

Every year since 1998 ChemWerth has hosted a two day cGMP training seminar in Shanghai, China. Open to all CW partner factories, the two days are spent reviewing updates on FDA guidance, common FDA findings, data integrity, compliance and cGMP standards. Actual case studies are reviewed to practice determining the correct course of action and emphasize the importance of supply chain integrity. This seminar was implemented 18 years ago with one objective, routine compliance. CW takes a proactive approach to routinely make sure a factory has the support and guidance it needs three-hundred and sixty five days a year, an objective we highly value. With your presence at this seminar, it shows your commitment to compliance and quality.

ChemWerth Continues to Excel with 59th DMF Available for Reference – Heparin Sodium

Every year roughly ten million Americans receive the blood-thinning drug heparin, however in 2008 contaminated heparin resulted in about 350 adverse events and 150 deaths in the United States alone. Since then, heparin has attracted increasingly stringent attention from the FDA. In 2009 the U.S. Food and Drug Administration (FDA) alerted healthcare providers of a change to the United States Pharmacopeia (USP) monograph for heparin. The increased scrutiny of heparin coming into the United States has created a market where only suppliers who can reliably source high quality heparin while tracing its origin will be able to successfully and safely supply the U.S. market.

ChemWerth is leveraging its 34 years of strong compliance standards to bring the industry a heparin source that is high quality, reliable and traceable. Every step of the heparin process throughout the supply chain is now required to be documented. The tracking and traceability measures put forth by the FDA and other regulatory bodies around the world fall right into ChemWerth’s business model “one world, one quality.”

Through extensive compliance expertise, ChemWerth has once again pioneered a reliable supply chain to which the final product can confidently be tracked to the initial source while having full control and overseeing the process along the way.

About ChemWerth, Inc.
ChemWerth is a world leader in developing and supplying specialty Generic Active Pharmaceutical Ingredients for the human and animal health markets. The company continues to rank #1 in DMFs Available for Reference among all other peer active pharmaceutical ingredient companies. ChemWerth is the regulatory agent for numerous FDA approved facilities in China, the United States, Europe and India. The company sells to the top generic pharmaceutical companies in the industry and sells products in 38 countries around the globe. For more information about the company please visit chemwerth.com.

ChemWerth Hits Milestone with 50th DMF Available For Reference, Commits to Strong Pipeline of Future APIs

The company continues to rank #1 in DMFs Available for Reference

ChemWerth, Inc., is pleased to announce that since the inception of Generic Drug User Fee Amendments (GDUFA) in 2012, the company has filed its 50th Drug Master File that the FDA has deemed as Available for Reference. The company continues to rank #1 in DMFs Available for Reference among all other peer active pharmaceutical ingredient companies.

“Contrary to an industry trend which has seen many competitors decrease their API development, we have stepped on the accelerator. We will continue to invest in specialty generic API products to support our customers around the globe, and we are committed to our vision of One World, One Quality generic APIs,” said Peter J. Werth, President and CEO, ChemWerth, Inc.

In addition to filing its 50th DMF available for reference, the company has 45 first to file APIs. Werth added, “Our customers have come to rely on ChemWerth to provide them with first to market advantage. This provides our customers with a big competitive edge and that continues to be a big reason for our success.”

ChemWerth Opens Distribution in Mexico and Central America

Supplier of APIs for generic drug formulations expands its reach

ChemWerth, Inc. has expanded distribution into Mexico and Central America, striking a deal with IDEOS Servicios y Especialidades Quìmicas S.A. de C.V. in Corregidora, Querétaro. The company will serve as ChemWerth’s sales agent for its generic active pharmaceutical ingredients (API).

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Generics Demand Stronger Proscriptions in REMS Compliance Letter Guidance

FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety / Submissions and Approvals
Generics Demand Stronger Proscriptions in REMS Compliance Letter Guidance

Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain bioequivalence testing batches for drugs protected by REMS product safety protocols.

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GDUFA Fee Exemptions – A Distant Bell for Small Businesses and CMOs

Nobody likes to part with money – in business or otherwise. That being said, the idea of GDUFA fees makes sense. Long term, the fees are expected to fund faster review times, induce a higher level of compliance and safety, and even eliminate the submission of hollow applications, leaving only the well-funded players on the field. All of this is good news. But what if you’re a small to mid-sized generic drug manufacturer or a CMO that is trying to make a name for yourself in the generic drug space? Whether your company is a $20 billion industry giant or a newly formed small business with one product under development, the fee is exactly the same.

With an average approval time of over 30 months, a small company with one product waiting for market approval could potentially pay the hefty GDUFA Facility Fee for a minimum of three years without seeing a single penny in product revenue. This has left many smaller players in the generic drug arena wondering why there isn’t a tiered fee structure similar to the AGDUFA program (Animal Generic Drug User Fee Act) or a waiver for small businesses similar to PDUFA (Prescription Drug User Fee Act) or even a postponed due date until after the application is approved, also similar to PDUFA.

While a small business waiver seems like the most logical path, there have been unsuccessful attempts to include a waiver or tiered fee structure component into GDUFA.

  1. 2012 FDA Safety and Innovation Act (FDASIA) – A fee waiver, originally included in the bill, was removed after the FDA and industry stakeholder groups like GPhA opposed its inclusion. The reasoning? It was believed the benefit of faster review turnaround and inspections for small to mid-size companies far outweighed the economic hardship of paying the fee.
  2. Citizen’s Petition filed by Square Pharmaceuticals in February 2013 requested the GDUFA fee be assessed one time rather than on an annual basis until approval of their first ANDA. The FDA denied the petition, explaining that the statutory language of the law could not be changed.
  3. Small Manufacturer Protection Act of 2013 introduced by Representative Robert Hurt (R-VA) was specifically designed to support smaller generic drug manufacturers but remains stagnant in the House Energy and Commerce Committee.

Part of the rationale for the exclusion is the FDA’s attempt to move away from administrative complexity. But at what or who’s cost? An amendment to the fee structure could alleviate financial hardship, promote innovation and opportunity, and accelerate the growth of smaller companies. This would be a big win for not only small businesses but also for the industry giants. These smaller companies are attractive to the larger companies as many times they service market niches that larger companies do not have the flexibility to focus on thus may acquire or invest in these smaller companies to expand their capabilities. Even GPhA, an original supporter of the flat fee, is now acknowledging the need for a reassessment of the fee structure.

As this topic seems to be growing momentum, a new piece of legislation may be introduced to amend FDASIA sooner rather than later. However, it is also a possible the FDA will wait until the first 5-year cycle of GDUFA at the 2017 renewal date to reassess the fee structure. As a 30 year generic API supplier to both large companies and small, ChemWerth would support this amendment.