China Honors Generic Pharmaceutical Visionary Peter Werth

In an unexpected reception fit for a king, China based API manufacturing facility, Jinan Jinda Pharmaceutical Chemistry Company, honored President and CEO of ChemWerth, Peter Werth as not only an industry “Pioneer and Mentor” but also as a “Philanthropist and Friend.”

ChemWerth’s story began in 1979 in a one room home office in Connecticut. Peter Werth, at this point, a veteran in the generic pharmaceutical industry, saw an opportunity to produce USFDA quality pharmaceutical ingredients in China following cGMP. At the time, no one thought it was possible. The environment was too complicated and companies didn’t think sourcing quality API from China was realistic. Werth rolled up his sleeves and went to work. He became versed in the local market and worked tirelessly with the factories to get them up to cGMP certified quality. Fast forward 35 year later and sourcing from China is the industry norm.

In recognition of his accomplishments, Jinan Jinda bestowed on ChemWerth’s founder a public dedication, a statue in his likeness and a plaque highlighting his achievements and contributions to Jinda’s and China’s success in the industry. Congratulations Peter on the much deserved recognition!

cw-image2

With over 30 years of experience, our responsibility has always been to helping our customers develop safe products for everyone across the globe with a ‘One World-One Quality’ approach that is the back bone of everything we do, every decision we make; making ChemWerth the ‘One Company’ for your API needs.

FY2015 Facility Fees

On August 2nd, the FDA published the Facility Fees for Fiscal Year 2015 and as anticipated they have increased from FY 2014. Due on October 1, 2014, the FDA has provided a high level overview of what is expected and the consequences of not following through on this obligation. Your biggest concern should be managing the follow through of your API Supplier as you risk loss of market share, damaged reputation and loss of filing fee.

Who Needs to Pay? Any facility that has been identified since the implementation of GDUFA or plans to be identified during the upcoming fiscal year in a generic drug submission for a Finished Dosage Form and/or API is required to pay the facility fee. Facilities that manufacturer both Finished Dosage and API are required to pay BOTH fees.

GDUFA Facility Fees
FY2013 FY2014 FY2015
Domestic FDF $175,389 $220,152 $247,717
Foreign FDF $190,389 $235,152 $262,717
Domestic API $26,458 $34,515 $41,926
Foreign API $41,458 $49,515 $56,926

Note that foreign facility fees are higher than domestic facility fees because of the higher costs of overseas inspections.

FY2015 Facility Fees

  1. The facility will be placed on the GDUFA Facility Arrears List if the fee is not fully paid within 20 days of the due date.
  2. Generic drug submissions referencing the facility will not be received by the FDA until the fee is paid.
  3. All Finished Dosages or APIs manufactured in the non-paying facility and all Finished Dosages containing APIs manufactured in a non-paying facility will be considered misbranded. Misbranded products will be denied entry into the United States and could result in prosecution, injunctions and/or product seizures.

    More information can be found – GDUFA Fee Info

This is a great time for the generic drug industry.

While the globalization of our business has posed both opportunities and challenges, companies that can demonstrate a track record of success and product excellence are thriving while those that are lacking are being weeded out. Your company’s reputation as a high quality, reliable drug source in good standing with the FDA is the key to long term success… and that all begins with a dependable API supply partner.

Foreseeing the need for a ‘One World – One Quality’ approach to doing business, our involvement with partner factories for which ChemWerth was the regulatory agent expanded. The goal has always been to maintain a high level of compliance at the factory, not just during FDA inspections, but 365 days of the year. The Factory Regulatory Compliance Program and the Regulatory Documentation Compliance Program were both broadened to cover ALL APIs manufactured and exported from the factory, not just the ChemWerth affiliated products. The result was an outstanding 59% increase in zero 483s issued. In the last 3 years, ChemWerth has facilitated 34 FDA inspections. All 34 passed inspection. 17 of those 34 passed with zero 483s and the remaining 17 passed with minor deficiencies; an impressive compliance record in today’s FDA GDUFA environment. We also understand the importance of a high quality DMF and are willing to invest in this endeavor which can be attested to by the fact that ChemWerth is ranked 2nd in DMFs Available for Reference*, according to the FDA’s Type II Drug Master Files – Available for Reference List as of March 7, 2014.

DMF-Chart-API-Only

With over 30 years of experience, our responsibility has always been to helping our customers develop safe products for everyone across the globe with a ‘One World-One Quality’ approach that is the back bone of everything we do, every decision we make; making ChemWerth the ‘One Company’ for your API needs.

*Data does not include vertically integrated companies.

How to Avoid a Refuse-to-Receive Under the New ICH Stability Guidelines

With the June 20th deadline looming, there are many uncertainties regarding what will happen on June 21st. From published reports in the Pink Sheet and Generics Bulletin, the FDA has rejected about 40% of all ANDAs filed in fiscal year 2014. With the rush to meet the June 20 deadline, it is anticipated that a flood of applications will be filed in the next two weeks. By some estimates, more applications will have gone into the FDA in the months of May and June than the rest of the year combined. The current rejection rate combined with the hiring and training of 400+ new people at the FDA to handle the GDUFA workload and the massive influx of new ANDA applications may be the perfect set up for a disaster.

As Senior Vice President of Sales at ChemWerth, I am in the unique position to hear about the top issues and concerns from our Finished Dosage customers. This, in turn, allows ChemWerth to get a broad understanding of the stumbling blocks our partners are facing with respect to the FDAs new and constantly evolving recommendations. Outside the usual checklist of items like paying fees and making sure the DMF is on the AFR list, the best advice I can give in these last 10 days is to be sure your filing is in perfect condition. While the pressure is on to get as many filings submitted before the deadline, it is in your company’s best interest to file fewer high quality ANDAs, than file a greater number of mediocre quality. Mediocrity will most likely produce a Refuse-to-Receive which in turn will cause you to lose your filing fee and force you to refile under the new stability guidance of 3 batches and 6 months stability data. Under the FDA environment that exists today, quality is more important than quantity.

As a full service generic API development and supply company with over 30 years of experience, ChemWerth has a skilled regulatory team dedicated to managing your submission and approval process from beginning to end. We know how to navigate through the constantly changing guidelines and have a 31 year track record of compliance and product excellence with a ‘One World-One Quality’ approach that is the backbone of everything we do, every decision we make; making ChemWerth the ‘One Company’ for your API needs.

Overseas Generic Drugs: Problem and Solution

The FDA is making good on their promise. The dollars generated from GDUFA fees are funding the increased scrutiny of overseas generic drug suppliers. As a result, the quality of many finished dosage companies are making headlines, as exampled below.

Medicines Made in India Set Off Safety Worries
Article published in New York Times, February 14, 2014

The implementation of GDUFA has allowed the FDA to increase resources to inspect overseas finished dosage facilities as well as API providers. The bar has been raised for those that want to participate in key regulated markets like the US and EU and it appears this might just be the tip of the iceberg. These inspections have become a top priority for the FDA. If you haven’t already received a knock on your door, you will. It’s only a matter of time. The FDA is coming.

The Big Picture:

GDUFA’s focus on safety, accessibility and transparency in an effort to provide low cost, high quality pharmaceuticals to the US generic drug market is good for the industry. However, it will continue to be overwhelming as companies try to keep track of supplier quality, submission checklists, facility standards, increased inspections, fee obligations, and all of the other requirements involved in getting a drug to market. Businesses that can endure this paradigm shift will have a competitive advantage over those companies that struggled with acclimating or shut down for good. So, how do you do it?

The Solution:

Minimize your variables. Focus on your facility and let ChemWerth worry about the quality of your API and all of the back office work involved in getting the DMF Available for Reference. Within the past 12 months, ten of ChemWerth’s represented factories in China and India have been inspected by the FDA. All ten passed inspection. Six of those ten passed with zero 483s. We know how to navigate through the constantly changing guidelines and have a 31 year track record of compliance and product excellence. Our responsibility to helping our customers develop safe products for everyone in every country, makes ChemWerth the “go to” source for API supply and management with a ‘One World-One Quality’ approach that is the back bone of everything we do, every decision we make; making ChemWerth the ‘One Company’ for your API needs.

Quality of API Supplier Can Lead to Refuse-to-Receive Decision

One year after the implementation of GDUFA, the FDA has met their timeline by providing guidance on enhanced Refusal-to-Receive standards for ANDAs and related submissions. The Guidance for Industry ANDA Submissions – Refuse-to Receive Standards, published October 2013, provides clarification on the Refuse-to-Receive criteria which will improve the quality of ANDA submissions ultimately leading to faster FDA approval time. Full implementation is expected June 20, 2014.

The guidance identifies the types of deficiencies that would prompt a Refuse-to-Receive decision in addition to defining major vs. minor deficiencies, steps to resolve deficiencies and the consequences for each type of deficiency. The areas that deficiencies can occur fall into the following six categories:

  1. Missing Application Form FDA 356h
  2. Organization and Format of ANDA Submission
  3. GDUFA Fee Obligations
  4. Labeling
  5. Type II DMF and API Review
  6. Chemistry, Manufacturing and Control

Type II API DMF Review Deficiencies
How will the quality of your API supplier affect your company’s ability to maintain a fast to market advantage? The FDA’s Refuse-to-Receive guidance specifically identifies the following deficiencies as it relates to API suppliers and manufacturers.

  • ANDA references a Type II API DMF not on Available for Reference list because of non-payment of the GDUFA DMF fee.
  • ANDA references a Type II API DMF submitted to FDA after the ANDA submission date.
  • ANDA references a Type II API DMF that has not received Available for Reference status from the FDA prior to the ANDA review date.**
  • ANDA references a Type II API DMF that initial Completeness Assessment is given “Incomplete” status.
  • ANDA references a manufacturer on the Facility Arrears List for failure to pay the GDUFA facility fee.

** As an added measure, the FDA is recommending Type II API DMFs should be submitted AT LEAST 6 months in advance of an ANDA submission.

The bottom line is, your API supplier matters now more than ever; choosing a company that has a commitment to regulatory compliance, product excellence, an understanding of the constantly changing regulatory guidelines and the financial stability to follow through on GDUFA fee commitments.

Our ‘One World-One Quality’ approach is the back bone of everything we do, every decision we make; making ChemWerth the ‘One Company’ for your API needs.

Possible good news for smaller generic drug manufacturers

Escape Hatch:
New Legislation Seeks to Provide a Way Out for Some Companies Subject to GDUFA User Fees

Article published on FDA Law Blog, December 2013

Possible Good News for Smaller Generic Drug Manufacturers: The Small Manufacturer Protection Act of 2013 proposing to waive or reduce GDUFA fees to level the playing field to accommodate smaller companies. While the implementation of GDUFA has induced global transparency and a One World – One Quality standard that will lead to safer pharmaceuticals, incentive is needed for new and smaller companies to continue to invest in the US market.

Keep track of this legislation as it moves through the House and Senate:
H.R. 3631: Small Manufacturer Protection Act of 2013

FDA Inspection Passes with Support from ChemWerth

December 2013

Woodbridge, CT/China – ChemWerth Inc. is pleased to announce two more successful overseas FDA audits in October. This adds up to 53 successful inspections in the past 5 years facilitated by ChemWerth. “We are particularly pleased with the most recent international inspections, which shows the GDUFA program is working. The FDA arrived at these Asian manufacturing facilities virtually unannounced, ready to go. There has been a longstanding belief by many that overseas facilities have 2 months to prepare for an audit and this is the only reason they can pass an inspection. This theory has now been debunked – at least when you are discussing ChemWerth partner factories. ChemWerth, with over 30 years’ experience in China, expects and welcomes parity between the US and foreign facilities when it comes to FDA inspections.” stated Peter Werth, President and CEO of ChemWerth.

As anticipated, a byproduct of the GDUFA fees and the FDA’s “Commitment Letter” is the amount of notice the FDA provides for an overseas inspection. “We have now gone from 2 months’ lead time to a knock on the door.” The global transparency induced by new guidance’s like GDUFA and regulations like EU Directive 62, is quickly weeding out the chemical companies; leaving pharmaceutical companies that invest in compliance as the only viable option.

ChemWerth understands the importance of working at a high level of quality 365 days of the year and believes the “One World – One Quality” approach will lead to safer pharmaceuticals and increased credibility for the generic industry.

ChemWerth at CPhI India Pharma Expo

3-5 December 2013

One World. One Quality. One Company.

ChemWerth is attending CPhI India and we would love to see you there. Join us December 3rd – 5th at the Bombay Convention and Exhibition Centre, Mumbai, India – Hall #1, Stand M32.

Our Goal: To foster existing partnerships and develop new alliances with manufacturers and pharmaceutical companies that share our vision of providing quality active pharmaceutical ingredients to consumers across the globe.

As a full service generic API development and supply company with over 30 years of experience, ChemWerth is your one stop shop – we are with you every step of the way from product selection to product launch.

Bottom Line: Our ability to navigate through the tough issues and get to market faster than the competition allows you to gain the advantage.

We would love the opportunity to discuss potential opportunities. For appointments with our team at CPhI please contact:

Jennifer Reale
CHEMWERTH, Inc.
Direct: 203-392-0466
Jennifer.Reale@chemwerth.com

ICH Stability Guidelines Postponed to June 2014

As per the June 2013 draft guidance ANDAs: Stability Testing Drug Substances and Products, the FDA intends on using the ICH Stability Guidelines as a benchmark for ANDA and DMF Type II submissions. Initially this was set to take effect January 1, 2014. However, with the efforts of GPhA, the implementation has been postponed nearly six months to June 20, 2014.

A Quick Overview
So, how will this change affect your projects and how to best leverage this information before the ICH Guidelines are adopted?

Current Filing
Requirements
Filing Requirements
as of June 20, 2014
Finished Dosage One Exhibit Batch for ANDA filing Three pilot scale batches.
OR
Two pilot scale batches
and one small scale batch.
Finished Dosage A three month Long Term stability sample for one Exhibit Batch. Six month Long Term and Accelerated
stability data for three batches.
Active Pharmaceutical Ingredient A three month Long Term stability sample for one API lot. Six month Long Term and Accelerated stability data for three API lots. A minimum of two lots of the drug substance should be used to prepare the three primary batches of drug product for ANDA application.

Additional stability studies will translate into a need for additional resources – space, equipment, personnel, materials, etc. Bottom line – your stability testing costs are going to increase. Now is the time to:

  • Move ahead on projects that have been temporarily put aside
  • Accelerate development efforts of more expensive products.

How We Can Help
As a full service generic API development and supply company with over 30 years of experience, ChemWerth is your one stop shop – with you every step of the way from product selection to product launch. Our ability to navigate through the tough issues will help you submit your ANDAs before June 20th, so you can get to market faster.

In an effort to help identify and push projects forward, our sales team will be reaching out to you to discuss where to best focus efforts over the next 10 months.