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Nanjing Well Biotech's self-monitoring plan & March 2025 report

14 Apr 2025

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2025 Q1 Testing Report Includes 2024 Hazardous Waste Disposal

14 Apr 2025

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Nanjing Well Biotech's self-monitoring plan & report Jan 2025

05 Mar 2025

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DATA COMPILATION
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DIGITAL CONTENT

3 Corporate Content #SupplierSpotlight, 2 Data Compilation #PharmaFlow, 15 News #PharmaBuzz

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3 Corporate Content #SupplierSpotlight
2 Data Compilation #PharmaFlow
15 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

4 All APIs, 4 Listed APIs

4 All APIs
4 Listed APIs

EXCIPIENTS

3 All Excipients, 3 USDMF, 1 CEP/COS, 55 Listed Products

excipientPortfolio
3 All Excipients
3 USDMF
1 CEP/COS
55 Listed Products

KEY EXCIPIENTS

Polysorbate 20, Polysorbate 80, Polyoxyl 15 Hydroxystearate, Polyoxyethylene (35) Castor Oil, Poloxamer 188, Oleic Acid, Sodium Oleate, Egg Yolk Lecithin, Soybean Lecithin, Polyethylene Glycol 300, Polyethylene Glycol 400, Polyethylene Glycol 4000, Propylene Glycol, Squalene, Castor Oil, Benzyl Alcohol, Lactose Monohydrate, Trehalose, Polyethylene Glycol 3350, Polylactide-co-glycolide (75:25), Polylactide-co-glycolide (50:50), Polylactide-co-glycolide (85:15), Sorbitan Oleate (Span 80), Polyoxyethylene (40) Hydrogenated Castor Oil, Polyoxyl 60 Hydrogenated Castor Oil, Polyoxyl 40 Stearate, Polyoxyl 20 Cetostearyl Ether, Polysorbate 60, Sorbitan Stearate (Span 60), Poloxamer 407, Polyoxyl 25 Cetostearyl Ether, Laurel Sorbitan (Span 20), Polyoxyethylene 7 Stearate, MPLA, QS21, Sorbitan Trioleate (Span 85), Sucrose Laurate, Poloxamer 182, Polysorbate 40, Sorbitan Palmitate, Soybean Oil, Glyceryl Dioleate, Trehalose 6,6 Dibehenate, Dimethyl Dioctadecyl Ammonium Bromide (DDAB)

Polysorbate 20
Polysorbate 80
Polyoxyl 15 Hydroxystearate
Polyoxyethylene (35) Castor Oil
Poloxamer 188
Oleic Acid
Sodium Oleate
Egg Yolk Lecithin
Soybean Lecithin
Polyethylene Glycol 300
Polyethylene Glycol 400
Polyethylene Glycol 4000
Propylene Glycol
Squalene
Castor Oil
Benzyl Alcohol
Lactose Monohydrate
Trehalose
Polyethylene Glycol 3350
Polylactide-co-glycolide (75:25)
Polylactide-co-glycolide (50:50)
Polylactide-co-glycolide (85:15)
Sorbitan Oleate (Span 80)
Polyoxyethylene (40) Hydrogenated Castor Oil
Polyoxyl 60 Hydrogenated Castor Oil
Polyoxyl 40 Stearate
Polyoxyl 20 Cetostearyl Ether
Polysorbate 60
Sorbitan Stearate (Span 60)
Poloxamer 407
Polyoxyl 25 Cetostearyl Ether
Laurel Sorbitan (Span 20)
Polyoxyethylene 7 Stearate
MPLA
QS21
Sorbitan Trioleate (Span 85)
Sucrose Laurate
Poloxamer 182
Polysorbate 40
Sorbitan Palmitate
Soybean Oil
Glyceryl Dioleate
Trehalose 6,6 Dibehenate
Dimethyl Dioctadecyl Ammonium Bromide (DDAB)

EXCIPIENTS BY INGREDIENTS

PLGA Polymers, Octyldodecanol, Soya Lecithin, Polyethylene Glycol 400, Polyethylene Glycol Monomethyl Ether 350, Sorbitol, Propylene Glycol, Polyethylene Glycol 7-Stearate, Sorbitan Excipient, Dimethyl Dioctadecyl Ammonium Bromide DDAB, Triethyl Citrate, Poloxamer 407, Trehalose 6,6 Dibehenate, Polyoxyl 15 Hydroxystearate, Squalene, Polyethylene Glycol 600, Crotamiton Excipient, Sorbitan Palmitate Excipient, Sorbitan Trioleate, Sorbitan Stearate Excipient, Polyethylene Glycol 6000 Excipient, Polyethylene Glycol 4000, Sucrose Laurate Excipient, Poloxamer 188, Polyoxyl 35 Castor Oil, Polyethylene Glycol 3350, Polyethylene Glycol 1500, Polyquaternium-7, sorbitan oleate, Polysorbate 80, Polysorbate 40, Cetostearyl Alcohol, Oleic Acid Excipient, Polyethylene Glycol 1000, Poloxamer 182, Polyoxyl 60 Hydrogenated Castor Oil, Polyoxyl 40 Hydrogenated Castor Oil, Castor Oil Excipient, Glyceryl Dioleate, Benzyl Alcohol, Polysorbate 60, Monophosphoryl Lipid A, Lactose Monohydrate, Sodium Oleate, Polyethylene Glycol 300, Sodium Laureth Sulfate, Trehalose, Polysorbate 20, Laurel Sorbitan, Polyoxyl 40 Stearate Excipient, Soybean Oil, Egg Yolk Lecithin, Polyoxyl 20 Cetostearyl Ether, Quillaja saponaria-21

excipientsByIngredients
PLGA Polymers
Octyldodecanol
Soya Lecithin
Polyethylene Glycol 400
Polyethylene Glycol Monomethyl Ether 350
Sorbitol
Propylene Glycol
Polyethylene Glycol 7-Stearate
Sorbitan Excipient
Dimethyl Dioctadecyl Ammonium Bromide DDAB
Triethyl Citrate
Poloxamer 407
Trehalose 6,6 Dibehenate
Polyoxyl 15 Hydroxystearate
Squalene
Polyethylene Glycol 600
Crotamiton Excipient
Sorbitan Palmitate Excipient
Sorbitan Trioleate
Sorbitan Stearate Excipient
Polyethylene Glycol 6000 Excipient
Polyethylene Glycol 4000
Sucrose Laurate Excipient
Poloxamer 188
Polyoxyl 35 Castor Oil
Polyethylene Glycol 3350
Polyethylene Glycol 1500
Polyquaternium-7
sorbitan oleate
Polysorbate 80
Polysorbate 40
Cetostearyl Alcohol
Oleic Acid Excipient
Polyethylene Glycol 1000
Poloxamer 182
Polyoxyl 60 Hydrogenated Castor Oil
Polyoxyl 40 Hydrogenated Castor Oil
Castor Oil Excipient
Glyceryl Dioleate
Benzyl Alcohol
Polysorbate 60
Monophosphoryl Lipid A
Lactose Monohydrate
Sodium Oleate
Polyethylene Glycol 300
Sodium Laureth Sulfate
Trehalose
Polysorbate 20
Laurel Sorbitan
Polyoxyl 40 Stearate Excipient
Soybean Oil
Egg Yolk Lecithin
Polyoxyl 20 Cetostearyl Ether
Quillaja saponaria-21

EXCIPIENTS BY APPLICATIONS

Parenteral, Topical, Solubilizers, Emulsifying Agents, Film Formers & Plasticizers, Thickeners and Stabilizers, Surfactant & Foaming Agents, Lubricants & Glidants, Fillers, Diluents & Binders, Taste Masking

excipientsByApplications
Parenteral
Topical
Solubilizers
Emulsifying Agents
Film Formers & Plasticizers
Thickeners and Stabilizers
Surfactant & Foaming Agents
Lubricants & Glidants
Fillers, Diluents & Binders
Taste Masking

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

About

Nanjing Well Pharmaceutical Group was established in 2000 & is committed to R&D & manufacture of pharmaceutical materials, base oils of advanced synthetic lubricants, etc. The group has 10 subsidiaries, which are distributed in Nanjing, Yangzhou, & other cities in China. Nanjing Well Pharmaceutical Technology is a wholly-owned subsidiary of the Group, & it is a new R&D & manufacturing center for pharmaceutical excipients & APIs. It is located in Nanjing Jiangbei New Material Science & Technology Park with 200+ employees & has 15 synthetic production lines which can achieve an annual output of >20,000 tons of pharmaceutical excipients & APIs.

CPhI ChinaCPhI China

Industry Trade Show

Booth #E3D78A

24-26 June, 2025

SNIEC, Shanghai, China
Europ. Pharma Outsourc...Europ. Pharma Outsourcing

Industry Trade Show

Not Confirmed

05-06 June, 2025

Düsseldorf, Germany
Peptide ForumPeptide Forum

Industry Trade Show

Not Confirmed

05-06 June, 2025

Biozentrum Basel

CONTACT DETAILS

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Country

China

Address

No.99, Changfenghe West Road, Chemical industrial Park, Nanjing, 210047

Telephone

+86 02583172922

mj@wellnj.com

Website

http://www.wellnj.com/

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CORPORATE CONTENT #SupplierSpotlight

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MPLA & QS-21

DATA COMPILATION #PharmaFlow

Excipient Market Overview: Roquette announces restructuring post IFF Pharma buyout; WHO, FDA advance regulatory frameworks

The pharmaceutical excipients market saw significant strategic consolidations, technological developments, and regulatory adaptations in 2025. Globally, the pharmaceutical excipients sector is growing at a compound annual growth rate of 6.6 percent, and was valued at US$ 8.85 billion in 2024. It is projected to reach US$ 14.77 billion by 2032.This year, the sector is witnessing technological advancements, regulatory evolution, and strategic business realignments. North America continues to dominate the global excipients landscape, with a 39.8 percent market share. The Asia-Pacific region is the fastest-growing segment with a substantial 30.4 percent market share, driven by increasing investments in pharmaceutical manufacturing, growing demand for cost-effective drugs, and rising healthcare expenditure across developing economies.Major excipient providers include BASF, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, DuPont, Evonik, Seqens, Actylis, SPI Pharma, PMC Isochem, Croda International, Pfanstiehl, Kewpie Corporation, Boai NKY Pharmaceuticals, ICE Pharma, Roquette, Nanjing Well Pharmaceutical, Minakem, Ashland Global, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Roquette restructures after buying IFF Pharma; Colorcon partners ASHA CelluloseIn May, Roquette completed its acquisition of IFF Pharma Solutions. Valued at up to US$ 2.85 billion in enterprise value, this transaction represents a major consolidation in the pharmaceutical excipients market. The acquisition significantly enhances Roquette’s ability to deliver high-value drug delivery solutions to pharmaceutical customers worldwide. Roquette announced a comprehensive, new organizational structure following the acquisition, indicating the company’s commitment to integrate IFF Pharma Solutions’ capabilities seamlessly into its existing operations. This consolidation creates a more robust platform for addressing the growing demand for specialized excipients in complex drug formulations, particularly as the industry moves towards more personalized approaches to medicines.So far, the year has also witnessed some strategic alliances, such as Colorcon’s partnership with ASHA Cellulose. As part of the deal, Colorcon will become the exclusive representative for two ASHA products — ASHACEL and ASHAKOTE — throughout Europe, the Middle East, Africa, Northeast Asia and Southeast Asia.Brenntag Specialties has announced an exclusive distribution agreement with MEGGLE Excipients to expand market reach. This collaboration makes available a broad portfolio of over 30 high-quality lactose-based excipients for various applications in the pharmaceutical industries across the Netherlands, Belgium, Norway, Finland, and Sweden.The portfolio’s versatility offers optimal solutions for a wide range of pharmaceutical applications, including tableting through both granulation and direct compression, powder preparations, and dry powder inhalation. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)WHO, FDA drive new standards with GMP guidelines; Pfanstiehl launches injectable-grade glycineIn March, the World Health Organization had put out a publication titled “Good Manufacturing Practices for Excipients used in Pharmaceutical Products.” WHO’s excipient GMP guideline emphasizes modern quality management principles, comprehensive risk assessment protocols, and supplier qualification procedures for excipients across all stages of production, storage, and distribution.Meanwhile, the US Food and Drug Administration (FDA) has proposed amendments to the Food, Drug, and Cosmetic Act as part of its FY 2025 legislative proposals, specifically targeting supply chain transparency for high-risk excipients. The FDA proposal would require certain excipients designated as high-risk to carry labeling that identifies the original manufacturer’s name and address. This initiative addresses what FDA has identified as a lack of transparency in excipient supply chains.In April, IFF Pharma Solutions launched Low Nitrite METHOCEL hydroxypropyl methylcellulose (HPMC). This innovative product is specifically designed to reduce the risk of nitrosamine formation in finished pharmaceutical dosages, addressing one of the most pressing concerns in contemporary pharmaceutical manufacturing.Pfanstiehl, a global leader in high-purity excipient manufacturing, announced the launch of its High Purity Low Endotoxin Low Metals (HPLE-LM) injectable-grade glycine. This multi-compendial glycine is specifically engineered for use in biologics, vaccines, and the downstream purification of monoclonal antibodies (mAbs). Manufactured under ICH-Q7 cGMP regulations at Pfanstiehl’s advanced facility in Waukegan, Illinois, the product meets stringent global pharmacopeial standards. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Shin-Etsu Chemical invests in Japan, Germany to expand cellulose productionIn March, Shin-Etsu Chemical announced investments in pharmaceutical cellulose business operations in Japan and Europe, thereby showing significant commitment to market expansion. The company is making substantial investments at two key bases: the subsidiary SE Tylose GmbH in Germany, and the Naoetsu Plant in Joetsu, Japan. In Germany, a new production facility for the pharmaceutical excipient L-HPC will be built adjacent to the existing facility, creating a dual base with the Naoetsu Plant. The excipients market in 2025 has seen innovation in functional applications. Research on BENEO’s Palatinose as a bedtime drink shows that it improves aspects of sleep and represents an innovative approach to excipient functionality. Palatinose is a naturally sourced, smart carbohydrate that provides full carbohydrate energy in a more balanced way, thanks to its low-glycemic profile.Gangwal Healthcare, with its EXCiPACT-certified GMP facilities and a robust portfolio of co-processed excipients like ProBlend, Starlose, and Microlose, is actively contributing to the pharmaceutical industry’s demand for functional excipients. The company also offers cellulose-based excipients such as Solvostar (Sodium Starch Glycolate) and Sallyso (Croscarmellose Sodium), designed to improve tablet disintegration and drug release profiles in oral solid dosage forms.Evonik announced a partnership with South Korea–based CDMO ST Pharm to expand its RNA and nucleic acid delivery services. This collaboration enables Evonik to integrate customized nucleic acids from ST Pharm seamlessly with its lipid and lipid nanoparticle (LNP) development and fill-and-finish services. This streamlined approach means that pharmaceutical companies can reduce complexity and increase speed-to-market for nucleic acid therapeutics. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Our viewThe pharmaceutical excipients market in 2025 is being shaped by several key trends including the development of multifunctional excipients that can simultaneously improve solubility, bioavailability, and control drug release in increasingly complex formulations.Moreover, the expanding generic medicines market is creating demand for cost-effective, versatile excipients. The growing importance of biologics and biosimilars is driving innovation in specialized excipients designed to maintain the stability and efficacy of these complex therapeutic products throughout their lifecycle. And nanotechnology continues to enable advanced nano-excipients for enhanced drug delivery and efficacy.In addition to these trends, we also notice a shift towards natural and plant-based excipients that is driven by sustainability concerns and potential biocompatibility benefits.

Impressions: 1551

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.

Impressions: 2669