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Site Map

© 2021 PuraCap® Pharmaceutical LLC
All Rights Reserved.

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

Prescription Branded &

Direct Dispense Products

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China In The News

This portion of the news is about Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.

Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. is a subsidiary company of Puracap Pharmaceutical, LLC

Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd was introduced on Phoenix TV and Wuhan Television show.

Piscataway, NJ–May 12, 2016

Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd was introduced on Wuhan Television show “Manufacturing Pioneer”. The show tells the story behind the successful FDA inspection of Humanwell Puracap Pharmaceuticals. Please see below youtube video. (In Mandarin)

Piscataway, NJ –July 17, 2016

Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd was introduced on Phoenix TV. The show tells the story of how Humanwell Puracap Pharmaceuticals use its rich talent and entered into the US Market. Please see below youtube video. (In Mandarin)

Sand drawing of PuraCap Pharmaceuticals’ history

HumanWell PuraCap Pharmaceutical LLC Announces second successful FDA Inspection of China Manufacturing Facility

Pending ANDA recommended for approval by FDA

PISCATAWAY, N.J., Sept. 18, 2017 — PuraCap Pharmaceutical LLC is pleased to announce the US Food and Drug Administration (FDA) has completed another successful general inspection of its affiliated soft gelatin capsule manufacturing facility, Humanwell PuraCap Pharmaceutical (Wuhan) Co, Ltd ,  located in Wuhan, Hubei Province China.  In addition, a pending ANDA was also recommended for approval as a result of this successful inspection.  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 September 11 through September 15.

Dahai Guo, Chief Executive Officer commented, ” This is our second successful FDA inspection within two years and  the continuation of the planning, development and training necessary to achieve our goal of building a world class pharmaceutical manufacturing facility in China. I am grateful for the tireless work of the Humanwell PuraCap team of manufacturing and quality professionals.”

Xiaofeng Meng, Ph.D/MBA General Manager of Humanwell PuraCap Pharmaceutical (Wuhan) Co., added, “We have always measured our cGMP and quality performance and have consistently achieved the highest potential scores on outside audits from global customers and third party authorities. A second FDA inspection without observations as well as the pending ANDA pre-approval is a testimony to our commitment to world-class quality.”

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 International).   PuraCap Pharmaceutical continues to innovate using our soft gel expertise and developing other oral solid options. Go to www.puracap.com for more information.

Media Contact:

info@puracap.com

908-941-5456

Humanwell PuraCap Pharmaceutical (Wuhan), Ltd Granted China’s National Top 100 Gazelle Enterprise Award

Receives Prestigious Award for Third Year in a Row

Piscataway, NJ–November 17, 2017 – PuraCap Pharmaceutical LLC is proud to announce the China Ministry of Science & Technology and Great Wall Strategy Consultants released the “National High-Tech District Development Report (2017)” on 3rd November 2017 and PuraCap’s China Operation, Humanwell PuraCap Pharmaceutical (Wuhan) Ltd, was named a National Top 100 Gazelle Enterprise.  Most impressive is that PuraCap is the only pharmaceutical enterprise to appear on this list.  Humanwell PuraCap Pharmaceutical (Wuhan) Ltd has been awarded the Gazelle Enterprise award for the past three years from 2015 to 2017.

PuraCap has overcome all of the challenges and achieved steady growth to be one of the top suppliers of softgel drugs in the US market. Dahai Guo, Co-Founder and Chief Executive Officer of PuraCap commented, “We are particularly proud to have trained and cultivated a first class management team and technical experts as we continue to grow in the pursuit of excellence. In the coming year, PuraCap shall advance to the next level in terms of capability, economic scale, and profitability.  More high-end, cutting edge products will be brought to market as testimony to our commitment to world-class quality.”

An idea that was created in Silicon Valley, “Gazelle Enterprise” refers to companies that enter a high speed development period and achieve success by overcoming seemingly insurmountable problems. Gazelle Enterprise companies are characterized as fast-growing, a strong innovation ability, new to the professional field and demonstrate huge potential. On the growth aspect, the latest two years’ income and average profit growth rate of Gazelle Enterprises should be more than 30%.

Media Contact:

info@puracap.com

908-941-5456

Manufacturing A World of Wellness

Global expertise in product development; producing quality, affordable pharmaceutical and healthcare products.

Click here to join our community

homeHOME

AS

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

© 2021 PuraCap® Pharmaceutical LLC
All Rights Reserved.

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

Prescription Branded &

Direct Dispense Products

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.

Click here for Fei Wang and Renfu Pharmaceuticals

HumanWell PuraCap Pharmaceuticals Announces Successful FDA Inspection

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 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.”

PuraCap Pharmaceutical Announces Site Visit by US Ambassador to China

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 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:
Elise Geiger
Vice President and General Manager
Branded Rx Products
Elise.klein@puracappharma.com
908-941-5456 ext. 1100

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 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 a 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 their three-prong approach for global growth with dedicated companies in the areas of prescription brands, PuraCap™ Pharmaceutical LLC; prescription generics, PuraCap™ Laboratories Inc.; and OTC and Private Label products, PuraVation™ Pharmaceuticals Inc. For more information on PuraCap™ Pharmaceutical LLC, visit the company’s website at http://www.PuraCap.com .

Contact: Elise Klein
908.941.5456; Email

SOURCE PuraCap Pharmaceutical LLC

China In The News

China In The News

China In The News

This portion of the news is about Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.

Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. is a subsidiary company of Puracap Pharmaceutical, LLC

HumanWell PuraCap Pharmaceuticals Announces Successful FDA Inspection Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd was introduced on Wuhan Television show “Manufacturing Pioneer”.

Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd was introduced on Phoenix TV and Wuhan Television show.

Piscataway, NJ–May 12, 2016

Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd was introduced on Wuhan Television show “Manufacturing Pioneer”. The show tells the story behind the successful FDA inspection of Humanwell Puracap Pharmaceuticals. Please see below youtube video. (In Mandarin)

Piscataway, NJ –July 17, 2016

Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd was introduced on Phoenix TV. The show tells the story of how Humanwell Puracap Pharmaceuticals use its rich talent and entered into the US Market. Please see below youtube video. (In Mandarin)

Sand drawing of PuraCap Pharmaceuticals’ history

HumanWell PuraCap Pharmaceutical LLC Announces second successful FDA Inspection of China Manufacturing Facility

Pending ANDA recommended for approval by FDA

PISCATAWAY, N.J., Sept. 18, 2017 — PuraCap Pharmaceutical LLC is pleased to announce the US Food and Drug Administration (FDA) has completed another successful general inspection of its affiliated soft gelatin capsule manufacturing facility, Humanwell PuraCap Pharmaceutical (Wuhan) Co, Ltd ,  located in Wuhan, Hubei Province China.  In addition, a pending ANDA was also recommended for approval as a result of this successful inspection.  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 September 11 through September 15.

Dahai Guo, Chief Executive Officer commented, ” This is our second successful FDA inspection within two years and  the continuation of the planning, development and training necessary to achieve our goal of building a world class pharmaceutical manufacturing facility in China. I am grateful for the tireless work of the Humanwell PuraCap team of manufacturing and quality professionals.”

Xiaofeng Meng, Ph.D/MBA General Manager of Humanwell PuraCap Pharmaceutical (Wuhan) Co., added, “We have always measured our cGMP and quality performance and have consistently achieved the highest potential scores on outside audits from global customers and third party authorities. A second FDA inspection without observations as well as the pending ANDA pre-approval is a testimony to our commitment to world-class quality.”

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 International).   PuraCap Pharmaceutical continues to innovate using our soft gel expertise and developing other oral solid options. Go to www.puracap.com for more information.

Media Contact:

info@puracap.com

908-941-5456

Humanwell PuraCap Pharmaceutical (Wuhan), Ltd Granted China’s National Top 100 Gazelle Enterprise Award

Receives Prestigious Award for Third Year in a Row

Piscataway, NJ–November 17, 2017 – PuraCap Pharmaceutical LLC is proud to announce the China Ministry of Science & Technology and Great Wall Strategy Consultants released the “National High-Tech District Development Report (2017)” on 3rd November 2017 and PuraCap’s China Operation, Humanwell PuraCap Pharmaceutical (Wuhan) Ltd, was named a National Top 100 Gazelle Enterprise.  Most impressive is that PuraCap is the only pharmaceutical enterprise to appear on this list.  Humanwell PuraCap Pharmaceutical (Wuhan) Ltd has been awarded the Gazelle Enterprise award for the past three years from 2015 to 2017.

PuraCap has overcome all of the challenges and achieved steady growth to be one of the top suppliers of softgel drugs in the US market. Dahai Guo, Co-Founder and Chief Executive Officer of PuraCap commented, “We are particularly proud to have trained and cultivated a first class management team and technical experts as we continue to grow in the pursuit of excellence. In the coming year, PuraCap shall advance to the next level in terms of capability, economic scale, and profitability.  More high-end, cutting edge products will be brought to market as testimony to our commitment to world-class quality.”

An idea that was created in Silicon Valley, “Gazelle Enterprise” refers to companies that enter a high speed development period and achieve success by overcoming seemingly insurmountable problems. Gazelle Enterprise companies are characterized as fast-growing, a strong innovation ability, new to the professional field and demonstrate huge potential. On the growth aspect, the latest two years’ income and average profit growth rate of Gazelle Enterprises should be more than 30%.

Media Contact:

info@puracap.com

908-941-5456