Boai NKY Pharmaceuticals Ltd | Fillers Diluents Binders | Excipient by Application

Boai NKY Medical Holdings Ltd. joins the UN Global Compact

29 Jun 2024

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Buy High Grade High Purity 99% PVM/MA 9011-16-9 In Stock with Best Price

18 Jan 2024

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BOAI NKY participates “2022 in-cosmetics” EU cosmetics raw exhibition Paris

15 Apr 2022

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DATA COMPILATION
#PharmaFlow

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CPhI Worldwide, Milan

Booth #6C50

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DIGITAL CONTENT

1 INTERVIEW #SpeakPharma, 8 CORPORATE CONTENT #SupplierSpotlight, 1 DATA COMPILATION #PharmaFlow, 13 NEWS #PharmaBuzz

media
1 INTERVIEW #SpeakPharma
8 CORPORATE CONTENT #SupplierSpotlight
1 DATA COMPILATION #PharmaFlow
13 NEWS #PharmaBuzz

EXCIPIENTS

7 All Excipients, 7 USDMF, 5 CEP/COS, 19 Listed Products

excipientPortfolio
7 All Excipients
7 USDMF
5 CEP/COS
19 Listed Products

KEY EXCIPIENTS

KoVidone® K25, KoVidone® K30, KoVidone® K90, KoVidone® VA64, PolyKoVidone Ultra XL, PolyKoVidone Ultra XL-10, PolyKoVidone XL, PolyKoVidone XL-10, KoVidone® Ultra VA64

KoVidone® K25
KoVidone® K30
KoVidone® K90
KoVidone® VA64
PolyKoVidone Ultra XL
PolyKoVidone Ultra XL-10
PolyKoVidone XL
PolyKoVidone XL-10
KoVidone® Ultra VA64

EXCIPIENTS BY INGREDIENTS

Crospovidone, Methyl Vinyl Ether and Maleic Acid Copolymer, Hydrogen Peroxide Excipient, Polyvinylpyrrolidone and Vinyl Acetate Copolymer, KoVidone K30, KoVidone K90, Polyvinylpyrrolidone, Methyl Vinyl Ether and Maleic Anhydride Copolymer, Polyvinylpyrrolidone K30, Polyvinylpyrrolidone K90, 2-Pyrrolidone, Polyvinylpyrrolidone K12, Povidone Iodine Excipient

excipientsByIngredients
Crospovidone
Methyl Vinyl Ether and Maleic Acid Copolymer
Hydrogen Peroxide Excipient
Polyvinylpyrrolidone and Vinyl Acetate Copolymer
KoVidone K30
KoVidone K90
Polyvinylpyrrolidone
Methyl Vinyl Ether and Maleic Anhydride Copolymer
Polyvinylpyrrolidone K30
Polyvinylpyrrolidone K90
2-Pyrrolidone
Polyvinylpyrrolidone K12
Povidone Iodine Excipient

EXCIPIENTS BY APPLICATIONS

Co-Processed Excipients, Fillers, Diluents & Binders, Disintegrants & Superdisintegrants, Direct Compression, Film Formers & Plasticizers, Solubilizers, Controlled & Modified Release, Thickeners and Stabilizers, Topical

excipientsByApplications
Co-Processed Excipients
Fillers, Diluents & Binders
Disintegrants & Superdisintegrants
Direct Compression
Film Formers & Plasticizers
Solubilizers
Controlled & Modified Release
Thickeners and Stabilizers
Topical

Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

About

Boai NKY Pharmaceuticals Ltd., with 36 years of experience, is one of the largest global PVP(polyvinylpyrrolidone) suppliers, Boai NKY is also the second-largest global manufacturer of PVM/MA products. Its pharmaceutical products are handled in class D cleanrooms and comply with government regulations, making it the first Chinese manufacturer to be EXCiPACT™ GMP certified. Boai NKY has a global distribution network and subsidiaries in Europe and Japan. Boai NKY’s commitment to sustainable production processes includes 100% recycling of processing water and the development of green production processes.

CPhI Worldwide, MilanCPhI Worldwide, Milan

Industry Trade Show

Booth #6C50

08-10 October, 2024

Fiera Milano, Italy
CPhI India 2024CPhI India 2024

Industry Trade Show

Exhibiting

26-28 November, 2024

India Expo Centre, Greater Noida
26th North American IS...26th North American ISSX

Industry Trade Show

Not Confirmed

15-18 September, 2024

Hawaii, USA

CONTACT DETAILS

Click the arrow to open the dropdown

Country

China

Address

No. 1888 East Wenhua Road, Boai, Jiaozuo, Henan Province

Telephone

+86 2258316066

sales@boai-nky.com

Website

http://eng.boai-nky.com/

https://www.linkedin.com/company/boai-nky-pharmaceuticals-ltd-/

Digital content

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INTERVIEW #SpeakPharma

“We owe our success to our focus on R&D, quality and better service”

This week, SpeakPharma interviews Ella Qu, General Manager & Director at China-headquartered Boai NKY Pharmaceuticals Limited, one of the world’s largest manufacturers of polypyrrolidone (PVP) and PVM/MA copolymer. While PVP is extensively used in the pharmaceutical industry as a binder in tablet manufacturing, PVM/MA copolymer is widely used in the cosmetic industry. In this interview, Ms. Qu talks about the company’s history, its product range and commitment to adopting green manufacturing practices.Can you tell us a bit about Boai NKY Pharma — its genesis, specializations and growth trajectory?Boai NKY Pharmaceuticals Limited was established in 1987. Back then, it was the first domestic company to develop and manufacture polyvinylpyrrolidone (PVP), a versatile ingredient used in pharmaceutical and cosmetic industries. In 2003, we got converted into a shareholding company.Innovation has been key to our growth strategy. In 2008, we researched and developed PVM/MA copolymer products. PVM/MA copolymer is an ingredient commonly used in oral care products such as denture adhesive, toothpaste, and can also be used in pharmaceutical applications.During the same period, we set up Tianjin Boai NKY International Limited, a whole share subsidiary company of Boai NKY. It operates all our international business.In 2010, we were publicly listed on the Shenzhen Stock Exchange. In 2015, we were certified by EXCiPACT GMP, a certification accepted by all major regulators around the world. In fact, we were the first manufacturer in China to obtain this certification. And in May this year, NKY Pharma became one of the largest PVP producers in the world and one of the largest producers of PVM/MA products in the world.What have been the reasons behind this success?NKY Pharma has always been dedicated to research and development. We have continuously worked towards introducing professionals in our company, and have strived to improve quality, to provide better service, to be more transparent and open to our customers.I attribute our success to these factors, and to our customers. Our aim has always been to establish mutually beneficial partner relationships. Going forward, our strong customer support coupled with our development in products and processes will stand us in good stead.How are you addressing the needs of customers spread across continents?Boai NKY Pharma has established its subsidiaries in Europe and the US. With the setting up of branch offices and warehouses, Boai NKY Pharma is able to communicate with its customers in a timely and effective manner.Could you provide more information about your product line, particularly KoVidone® and PolyKoVidone® lines of pharmaceutical excipients?KoVidone® and PolyKoVidone® polyvinylpyrrolidone (PVP) are widely used in the pharmaceutical field as excipients and are suitable for a broad range of dosage forms. KoVidone® K series products possess excellent binding, film-forming, dispersing and thickening properties and are widely used in the following dosage forms:• As a binder: These products are suitable for wet and dry granulation and direct compression in tableting. KoVidone® K improves particle compressibility and can be added to powder blends in dry or granulated forms through the addition of water, alcohol or hydro-alcoholic solutions.• As a solubilizer: These products are suitable for oral and parenteral formulations, enhancing the solubility of poorly soluble drugs in solid dispersion forms.• As a coating agent or binder: These products are suitable for coating of active pharmaceutical ingredients (APIs).• As a suspending, stabilizing or viscosity-modifying agent: These products are suitable for topical and oral suspension and solution applications. The solubility of poorly soluble drugs can be enhanced through the use of KoVidone®.KoVidone® also works as a viscosity modifier in tablet coatings. The addition of KoVidone® K30 to HPMC (hydroxypropyl methylcellulose) formulated film coating solutions can effectively reduce the viscosity of the HPMC solution while not affecting the resultant hydration profile of the resultant film.PolyKoVidone® possesses dual binding and disintegration properties, and enhances active solubilization. The product is used in the following applications: • Super disintegrant: Due to its excellent swelling characteristics in water, PolyKoVidone® can be used as a water-insoluble disintegrant for wet and dry granulation processes. The material can be added either before or after granulation in direct compression tableting processes. It exhibits high capillary activity and pronounced hydration capacity, without the formation of gel.• Solubility enhancer: PolyKovidone® increases the solubility of poorly soluble drugs via co-evaporation processes.• Suspension stabilizer: PolyKoVidone® increases viscosity and improves the dispersion properties to reduce the sedimentation rate of drugs, while increasing the re-dispersibility of said sediment. It is suitable for liquid and instant oral preparations.• Complexing agent of drug ingredients: PolyKoVidone® stabilizes active ingredients in pharmaceutical products, thereby improving drug solubility and bioavailability.How is Boai NKY Pharma committed to the development of green production processes?As a young company, the top management of Boai NKY Pharma has laid out a long-term planning and development strategy. We follow all environmental compliances mandated by the government.We are working towards making our production processes green through ways such as real time monitoring of waste streams, 100 percent recycling of processing water, and by switching from coal to natural gas.We are working with associations that are dedicated to sustainable development. Our growth and developmental goals will always be aligned with our commitment to environmental sustainability.

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CORPORATE CONTENT #SupplierSpotlight

Product List 2024

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Corporate Presentation

PolyViscol

EXCiPACT Certificate

Kosher Certificate

CFDA GMP Certificate

Halal Certificate

Corporate Video

DATA COMPILATION #PharmaFlow

Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards. Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio. Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients. The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.