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All PuraCap Pharmaceutical prescription
brand products meet our rigorous standards
for quality, accessibility and ease of therapeutic delivery.

PuraCap Laboratories develops & markets prescription generic medications to meet patient needs for quality, efficacy and affordable products.

Our over the counter (OTC) business, Puravation Pharmaceuticals provides many top quality, OTC store brand &
private label products.

With our turn-key services, we can develop Prescription and OTC soft gelatin capsules in our state of the art facility, designed and constructed in accordance with all US FDA cGMP regulatory guidances.

November 16, 2015

South Plainfield, NJ– November 3, 2015 – PuraCap Pharmaceutical LLC
announced today the introduction of a
new product, EpiCeram-L™ Lip Care,
a unique lip care formulation with an
exclusive delivery

July 10, 2014

PuraCap™ Pharmaceutical Introduces
Unique EpiCeram® 225g Airless Pump
EpiCeram® Controlled Release Skin
Barrier Emulsion Now Offers Dosing
Flexibility with 2 Sizes.

November 13, 2015

South Plainfield, NJ–November 11, 2015 – PuraCap Pharmaceutical LLC. is pleased to announce that the US Food and Drug Administration (FDA) has completed a successful inspection of its affiliated

May 19, 2014

Max Baucus, US Ambassador to China visits Wuhan Softgel Capsule Manufacturing Plant in Wuhan China
SOUTH PLAINFIELD, N.J., May 19, 2014 /PRNewswire/ — PuraCap Pharmaceutical today announced

Site Map

This site is only intended for residents of the United States. The products discussed on this website may have different labeling in different countries

PuraCap® Pharmaceutical LLC,
517 US-1 #4002
Iselin, NJ 08830

Phone: 908.941.5456
Fax: 908.941.5457

News

EpiCeram® is a leading prescription product that has the ability to help repair and heal the skin barrier through a unique mode-of-action different from other medications and eczema treatments. Typically, EpiCeram® is prescribed along with a topical steroid product, but EpiCeram® can also be prescribed alone. Only EpiCeram® contains the skin’s natural level of 3 essential lipids, such as ceramides, cholesterol and free fatty acids, which are reduced in patients with eczema or atopic dermatitis. EpiCeram® is steroid-free, fragrance-free, noncomedogenic1 , paraben-free, and propylene glycol-free.

EpiCeram-L™ Lip Care is the first of its kind, using a patented MultiSal™ Technology an exclusive multi-component controlled-release of important lipids, creating a moist, luxuriant feel.
EpiCeram-L™ Lip Care contains 3 essential lipids ceramides, conjugated linoleic acid (CLA) and cholesterol.
EpiCeram-L™ Lip Care is steroid-free, paraben-free, gluten-free, petrolatum-free, fragrance-free, color-free, and aloe rich to soothe lips on contact. It is ideal for the most severe, dry, cracked lips.

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PuraCap offers full service contract manufacturing services for your products. From concept to commercilazation, we can provide you with full turn-key commercial development services.

With full capabilities to develop Monographed OTC’s, ANDA’s, 505(b) (1) and 505(b) (2), we can provide quaility, reliablity and cost effective manufacturing and development services. Our R & D teams in New Jersey & Wuhan, China will work with you every step of the way, to bring your current or future project to full commercializaton.

Our state of the art 140,000 sq ft soft gel facility in Wuhan China meets all cGMP FDA regulatory requirements for pharmaceutical (Rx & OTC’s) development and manufacturing. With capacity of up the 4 billion soft gel capsules annually we have the ability to meet your needs. For more information please contact us at bd@puracap.com

A wide range of PuraCap products are manufactured by our affiliated manufacturing partner, Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd, a US FDA cGMP compliant facility that complies with international regulatory standards. Our goal is to put quality first, by building quality through design and a commitment to the highest standards. We strive to exceed USFDA, cGMP standards to assure our customers the quality product they expect.

The experienced manufacturing team, led by a well-recognized technical manufacturing authority in the soft gelatin pharmaceutical capsule industry, is committed to growing our business responsibly – utilizing proven and innovative processes and procedures to produce quality products without compromise. The manufacturing team is backed by a U.S. executive team with decades of experience in FDA (Federal Drug Administration) regulated prescription drug cGMP quality system management and process validation.

The Manufacturing team strives to provide cost-efficiency through manufacture at state-of-the art facilities built to USFDA specifications. Our model for success is to make use of labor as well as manufacturing efficiencies while meeting the highest quality standards. This model sets us apart from the competition. Our customers can be confident in our products—-highest quality at a competitive price.

Dahai Guo

Founder and CEO of PuraCap Pharmaceutical, LLC

Dahai Guo has a proven, successful track record of senior management experience with multi-billion-dollar healthcare and pharmaceutical companies including Hoffmann-La Roche, Inc., Inverness Medical, Inc., Ansell Healthcare (formally Pacific Dunlop Group) and Invitrogen. Mr. Guo specializes in global strategic planning, sales, marketing, product development and launching new brands for the healthcare product industry. He has successful experience in founding and growing start-up companies that later became listed on the NASDAQ. Mr. Guo has successfully marketed more than 2,000 Over the Counter and prescription products in over 90 different countries, including the United States, the European Union, China, Australia and several South American countries. Mr. Guo has a Master of Science degree in Biology from Rutgers University in New Jersey, and a Master of Business Administration degree in General Management from Cornell University in New York. He was trained to be a Six-Sigma Black Belt by the America Society for Quality.

Xiaofeng Meng, PhD

VP of Quality & Regulatory Affair

As VP of Quality & Regulatory Affair, Dr. Meng ensures compliance with all regulations and laws pertaining to the development and manufacturing of PuraCap products.

Dr. Meng has more than 15 years of pharmaceutical research and development, manufacturing and regulatory experience – including extensive experience formulating and executing regulatory strategies for proprietary and generic drug products and comprehensive knowledge of cGMP/GLP (current Good Manufacturing Practices/Good Labor Practices) compliance and quality systems.

As Director of Chemistry, Manufacturing and Controls (CMC) Management for Hurley Consulting Associates, Ltd., he interfaced with regulatory authorities, including the U.S. FDA (Food and Drug Administration) and EMA (European Medicines Agency), on behalf of clients throughout the drug development process, managed a CMC group, and prepared dossiers for various dosage forms, which resulted in successful submissions of multiple investigational and marketing applications for proprietary and generic drugs domestically and internationally.

As Senior Scientist II in Aerosol R&D for Abbott Laboratories, Inc. (formally Kos Pharmaceuticals, Inc.), Dr. Meng managed and supported projects leading to submissions of an Investigational New Drug for a proprietary and New Drug Application Supplements for a marketed asthma product.

Dr. Meng was also a Research Assistant at the Laboratory for Cancer Research at Rutgers University, where he authored many publications on cancer prevention and co-developed several analytical methods for tea catechins, which have been adopted for laboratories worldwide. He received the Gallo Award from the Cancer Institute of New Jersey in 1999, and the Award for Excellence in Graduate Research in Food Chemistry at the 2002 ACS National Meeting.

Dr. Meng’s academic degrees include: a Master’s in Business Administration from Rutgers University in New Jersey, a PhD in Food Science from Rutgers, and a Master’s degree in Pharmaceutical Science from the Shanghai Institute of the Pharmaceutical Industry, Shanghai, P.R. China.

He is a member of the American Association of Pharmaceutical Scientists (AAPS) and the American Chemical Society (ACS).

PuraCap® Pharmaceutical LLC introduces new EpiCeram-L™ Lip Care

Piscataway, NJ – November 3, 2015 – PuraCap Pharmaceutical LLC announced today the introduction of a new product, EpiCeram-L™ Lip Care, a unique lip care formulation with an exclusive delivery system for the treatment of dry lip conditions. PuraCap Pharmaceutical is the maker of EpiCeram® Controlled Release Skin Barrier Emulsion, a leading prescription product indicated for the treatment of dry skin conditions and management of burning and itching associated with various skin conditions including atopic dermatitis. The introduction of EpiCeram-L adds to PuraCap’s growing portfolio of dermatology products.

EpiCeram-L Lip Care is a unique lip care formulation with an exclusive delivery system developed specifically for severely chapped, dry, or cracked lips. EpiCeram-L Lip Care uses patented MultiSal™ technology to deliver 3 essential lipids – ceramides, free fatty acids and cholesterol in an all natural, steroid-free, paraben-free, fragrance-free, and color-free formulation. EpiCeram-L Lip Care is available exclusively through prescribing healthcare professionals.

“PuraCap has a strong, growing portfolio of dermatology products and EpiCeram-L Lip Care is an exciting new addition,” said Dahai Guo, CEO of PuraCap Pharmaceutical LLC. “We have listened to the needs of our customers and are pleased to introduce EpiCeram-L Lip Care.”

“Now there is a new option for patients who suffer from severely chapped, dry or cracked lips,” says Elise Klein, Vice President and General Manager of PuraCap’s Branded Rx division. “We look forward to continuing to meet the needs of our physicians and patients.” Physicians will be able to dispense EpiCeram-L directly to their patients from the office, which will make it very easy for patients to get the lip balm and begin treatment immediately. EpiCeram-L will be distributed through a patented web based ordering system. The program is designed to provide physicians easy access to PuraCap’s growing portfolio of dermatology products.

About PuraCap Pharmaceutical LLC

PuraCap Pharmaceutical LLC is an emerging, fully integrated pharmaceutical company with expertise in product development, manufacturing, and bringing affordable, world-class quality products to their customers. The PuraCap corporate structure supports a two-pronged approach for global growth with dedicated companies in the areas of prescription brands (PuraCap Pharmaceutical) as well as prescription generics and OTC and private label brands. PuraCap Pharmaceutical continues to innovate using our soft gel expertise and developing other soft gel options. Go to www.puracap.com for more information.

Forward-Looking Statement

All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which PuraCap Pharmaceutical LLC does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.

Media Contact:
info@puracap.com
908-941-5456

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HumanWell PuraCap Pharmaceuticals Announces Successful FDA Inspection

Piscataway, NJ –November 11, 2015 – PuraCap Pharmaceutical LLC. is pleased to announce that the US Food and Drug Administration (FDA) has completed a successful inspection of its affiliated soft gelatin capsule manufacturing facility, Humanwell PuraCap Pharmaceutical (Wuhan) Co, Ltd , located in Wuhan, Hubei Province China. The inspection confirmed that the site is compliant with Current Good Manufacturing Practices, and NO Form 483 observations were issued. This FDA inspection took place on May 18 through May 22, 2015.

Dahai Guo, Chief Executive Officer commented, “ This successful inspection is the culmination of years of planning, development and training to achieve our goal of building a world class pharmaceutical manufacturing facility in China. It reflects the tireless work of the Humanwell PuraCap team of manufacturing and quality professionals.”

Xiaofeng Meng, VP of Global Regulatory and Quality added, “We have always measured our cGMP and Quality performance and have consistently achieved the highest potential scores on outside audits from global customers as well as 3rd-party authority, such as UL-STR, Intertek etc. An FDA inspection without observations is a testimony to our commitment to world-class quality and continuous improvement.”

About PuraCap Pharmaceutical LLC
PuraCap Pharmaceutical LLC is an emerging, fully integrated pharmaceutical company with expertise in product development, manufacturing, and bringing affordable, world-class quality products to their customers. The PuraCap corporate structure supports a two-pronged approach for global growth with dedicated companies in the areas of prescription brands (PuraCap Pharmaceutical) as well as prescription generics and OTC drugs. PuraCap Pharmaceutical continues to innovate using our soft gel expertise and developing other oral solid options. Go to www.puracap.com for more information.

Forward-Looking Statement
All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which PuraCap Pharmaceutical LLC does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.

Media Contact:

info@puracap.com
908-941-5456

PuraCap® Pharmaceutical LLC Introduces Unique EpiCeram® 225g Airless Pump

Piscataway, NJ – July 7, 2014 PuraCap™ Pharmaceutical today announced the newest addition to the EpiCeram® product line, the EpiCeram® 225g Airless Pump. The unique airless pump gives patients more EpiCeram® to treat any size area of atopic dermatitis. The special dispensing system allows for more control, delivering EpiCeram® consistently and precisely in a convenient to use, portable, pump action dispenser. The EpiCeram® Airless Pump also offers cost savings with BID dosing and a controlled release formulation that is long lasting.

“Our physicians have been asking for a larger size, so we responded with a uniquely elegant pump dispenser that holds 2 ½ times more EpiCeram® than our 90g tube,” said Elise Klein, VP of Brand Marketing for PuraCap Pharmaceutical. “Offering both 90g and 225g size gives the provider flexibility to prescribe an amount that is right for each patient’s needs.”

EpiCeram® Controlled Release Skin Barrier Emulsion is a prescription product that helps to relieve the burning and itching associated with skin conditions such as atopic dermatitis/eczema. It is the only topical agent formulated with three essential lipids (ceramides, free fatty acids, and cholesterol) in a physiologically balanced ratio, which mimics the lipid concentration found in the skin. In addition, EpiCeram® is designed with a unique, patented, controlled release technology that delivers 24-hour barrier repair benefits with just a twice-daily application. A steroid-free topical formulation, EpiCeram® is FDA-cleared for the treatment of atopic dermatitis. For more information on EpiCeram® visit www.epiceram-us.com.

About PuraCap Pharmaceutical LLC

PuraCap Pharmaceutical LLC is an emerging, fully integrated pharmaceutical company with expertise in product development, manufacturing, and bringing affordable, world-class quality products to their customers. The PuraCap corporate structure supports a two-pronged approach for global growth with dedicated companies in the areas of prescription brands (PuraCap Pharmaceutical) as well as prescription generics and OTC and private label brands. PuraCap Pharmaceutical continues to innovate using our soft gel expertise and developing other soft gel options. Go to www.puracap.com for more information.

Forward-Looking Statement

All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which PuraCap Pharmaceutical LLC does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.

Media Contact:

info@puracap.com
908-941-5456

EpiCeram® Controlled Release Skin Barrier Emulsion Now Offers Dosing Flexibility with 2 Sizes

PuraCap Pharmaceutical Announces Site Visit by US Ambassador to China

Max Baucus, US Ambassador to China visits Wuhan Softgel Capsule Manufacturing Plant in Wuhan China

Piscataway, NJ – May 19, 2014 /PRNewswire/ — PuraCap Pharmaceutical today announced the visit of Max Baucus, US Ambassador to China, to the PuraCap Softgel Capsule Manufacturing Plant in Wuhan, China on May 14, 2014. Ambassador Baucus had the opportunity to tour the entire manufacturing plant. This visit is part of the Ambassador’s plan to visits enterprises throughout China. Ambassador Baucus is the 11th Ambassador to China, assuming office on Mar 20, 2014. He was accompanied by Vlad Lipshutz, US Consulate General in Wuhan.

“The Wuhan facility is a state of the art softgel capsule manufacturing plant and we are pleased that Ambassador Baucus had an opportunity to visit and observe manufacturing operations. We are excited that Ambassador Baucus chose to visit the PuraCap-China manufacturing facility so early in his tenure as Ambassador,” said Dahai Guo, CEO of PuraCap. Plant Director Maboob Rahman had the opportunity to demonstrate first-hand, the quality standards developed and implemented to meet strict US FDA cGMP manufacturing requirements. PuraCap is currently manufacturing and importing capsules to supply the US OTC market. Many US customers are now being supplied with softgel capsule pharmaceutical products manufactured by PuraCap.

About the Humanwell PuraCap Pharmaceutical (Wuhan), Ltd Softgel capsule Manufacturing Facility

Operational since 2011, the Wuhan pharmaceutical manufacturing facility was designed and built to meet and exceed regulatory standards, both from the US FDA, EMEA and CFDA quality requirements. The 140,000 sq foot facility is located in the capital of Hubei in Wuhan, China.

About PuraCap Pharmaceutical LLC

PuraCap Pharmaceutical LLC is an emerging, fully integrated pharmaceutical company with expertise in product development, manufacturing, and bringing affordable, world-class quality products to their customers. The PuraCap corporate structure supports a two-pronged approach for global growth with dedicated companies in the areas of prescription brands (PuraCap Pharmaceutical) as well as prescription generics and OTC and private label brands. PuraCap Pharmaceutical continues to innovate using our soft gel expertise and developing other soft gel options. Go to www.puracap.com for more information.

Forward-Looking Statement

All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which PuraCap Pharmaceutical LLC does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.

Media Contact:

info@puracap.com
908-941-5456

PuraCap’s Team EpiCeram® Joins Walk to Cure Eczema

Piscataway, NJ – May 22,2013 – Team EpiCeram is proud to announce its support of the National Eczema Association’s “Itching for a Cure” walk in New Jersey on June 8, 2013. Working together with the National Eczema Association, Team EpiCeram hopes to build awareness of eczema and help raise funds for a cure.

More than 30 million Americans suffer from eczema (or atopic dermatitis), an incurable disease of the skin, which is characterized by chronic itch and inflammation.

Click here to download full Press Release

Team EpiCeram, is walking to find a cure for eczema. “We’re excited to be joining the National Eczema Association to help millions of Americans who suffer from eczema”, said Elise Klein, Vice President, Brand Marketing and Strategic Planning. “Through this sponsorship and our participation we champion our commitment to help improve the lives of those living with eczema”.

EpiCeram Controlled Skin Barrier Emulsion is a prescription product that helps to relieve the burning and itching associated with skin conditions such as atopic dermatitis/eczema. It is the only topical agent that is formulated with three essential lipids (ceramides, free fatty acids, and cholesterol) in a physiologically balanced ratio, which mimics the lipid concentration found in the skin.

For more information and full prescribing information, please visit: www.epiceram-us.com.

EpiCeram Controlled Release Emulsion is distributed by PuraCap Pharmaceutical LLC.

About PuraCap Pharmaceutical LLC

PuraCap Pharmaceutical LLC is an emerging, fully integrated pharmaceutical company with expertise in product development, manufacturing, and bringing affordable, world-class quality products to their customers. The PuraCap corporate structure supports a two-pronged approach for global growth with dedicated companies in the areas of prescription brands (PuraCap Pharmaceutical) as well as prescription generics and OTC and private label brands. PuraCap Pharmaceutical continues to innovate using our soft gel expertise and developing other soft gel options. Go to www.puracap.com for more information.

Forward-Looking Statement

All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which PuraCap Pharmaceutical LLC does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.

Media Contact:

info@puracap.com
908-941-5456