Lactose Monohydrate | Pharma Excipients | News | Suppliers

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: 3680

MARKET PLACE

Do you need sourcing support? Ask us

EXCIPIENTS

Various Excipients needed in India [ENA24717]

A company that focuses on the manufacturing of pharmaceutical products is looking for suppliers of Various Excipients for development purposes. The suppliers must support this enquiry with CoA. 1. Croscarmellose Sodium Excipient 2. Microcrystalline Cellulose Excipient 3. Lactose Monohydrate Excipient 4. Colloidal Silicon Dioxide Excipient 5. Magnesium Stearate Excipient

03 Dec 2025

Various Excipients needed in India [ENA22797]

A company that focuses on the development and manufacturing of various finished formulations is looking for suppliers of Various Excipients for commercial purposes. The suppliers must support this enquiry with CEP & CoA. 1. EP /BP Grade Magnesium Stearate Excipient 2. EP /BP Grade Talc Excipient 3. EP /BP Grade Polyvinylpyrrolidone Excipient 4. EP /BP Grade Maize Starch Excipient 5. EP /BP Grade Lactose monohydrate Excipient 6. EP /BP Grade Isopropyl alcohol Excipient

28 Apr 2025

Various Excipients needed in Nigeria [ENA21630]

A company that focuses on manufacturing of various finished formulations is looking for suppliers of Various Excipients for commercial purposes. The suppliers must support this enquiry with CoA. 1. Lactose Monohydrate (3 MT) Excipient 2. Dextrose Monohydrate (20 MT) Excipient 3. Maize Starch (5 MT) Excipient

03 Jan 2025

Lactose Monohydrate (5 kg) Excipient needed in India [ENA21581]

A company that focuses on manufacturing of various finished formulations is looking for suppliers of Lactose Monohydrate (5 kg) Excipient for development purposes. The suppliers must support this enquiry with CoA.

28 Dec 2024

Various Excipients needed in India [ENA21024]

A company that focuses on manufacturing of various general and oncology active pharmaceutical ingredients is looking for suppliers of IP Grade Various Excipients for commercial purposes. The suppliers must support this enquiry with CoA. 1. Microcrystalline Cellulose Excipient 2. Lactose Monohydrate Excipient 3. Sodium Starch Glycolate Excipient 4. Hydroxypropylmethylcellulose Excipient 5. Sodium Lauryl Sulfate Excipient 6. Magnesium Stearate Excipient 7. Lactose Anhydrous Excipient 8. Croscarmellose Sodium Excipient

04 Nov 2024

Lactose Monohydrate (50 MT/ annum) Excipient needed in Indonesia [ENA19789]

A company specializing in the production of various prescription medications, over-the-counter (OTC) products, and veterinary medicines for both domestic and international markets is looking for suppliers of Lactose Monohydrate (50 MT/ annum) Excipient for commercial purposes. The supplier must support this enquiry with open & closed part DMF & CoA

24 Jun 2024

Various Excipient needed in India [ENA19671]

A company that specializes in manufacturing various finished formulations across various therapeutic areas is looking for suppliers of Various Excipients for commercial purposes. The supplier must support this enquiry with CoA. 1. BP Grade Methylene Dichloride (400 kg) Excipient 2. BP Grade Lactose Monohydrate (175 kg) Excipient 3. BP Grade Mannitol Crystalline (75 kg) Excipient 4. BP Grade Crospovidone (75 kg) Excipient 5. BP Grade PVP K-30 (50 kg) Excipient 6. BP Grade Calcium Stearate (25 kg) Excipient 7. BP Grade Pregelatinised Starch (25 kg) Excipient 8. BP Grade Microcrystalline Cellulose (500 kg) Excipient

10 Jun 2024

Lactose Monohydrate (150 mesh & 80 mesh) Excipient needed in Egypt [ENA19165]

A company that focuses on manufacturing of various finished formulations of veterinary is looking for suppliers of Lactose Monohydrate (150 mesh & 80 mesh) Excipient for commercial purposes. The required quantity is 6,000 kg. The supplier must support this enquiry with CoA.

08 Mar 2024

Lactose Monohydrate (20 MT) Excipient needed in Iran [ENA18905]

A company that focuses on trading of various pharmaceutical products is looking for suppliers of Lactose Monohydrate (20 MT) Excipient for commercial purposes. The supplier must support this enquiry with CoA.

15 Jan 2024

USP Grade Lactose Monohydrate Excipient needed in Mexico [ENA18640]

A company that focuses on distribution of various pharmaceutical products is looking for suppliers of USP Grade Lactose Monohydrate Excipient. The required quantity is 316 Tons/ annum. The suppliers must support this enquiry with CoA.

17 Nov 2023

Only 10 entries up to this point, click to access all

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

REF. STANDARDS & IMPURITIES

Upload your portfolio for free, ask us

Others

01

XYZ Pharma

Gabon

34th NZW-Hamburg

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Privacy policy
Terms and conditions
Disclaimers
Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

Looking for Lactose Monohydrate pharmaceutical excipients? Find information on Lactose Monohydrate's applications, manufacturers, suppliers, etc. on PharmaCompass.

CHEMISTRY

Browse all information

INACTIVE PHARMA INGREDIENTS

9 Suppliers

8 USDMF

1 NDC API

17 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

2004 FDF Dossiers Suppliers

92 FDA Listed Dossiers

EXCIPIENTS BY APPLICATIONS

9 Fillers, Diluents & Binders

7 Granulation

5 Direct Compression

2 Co-Processed Excipients

1 Parenteral

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow

MARKET PLACE

21 EXCIPIENTS

REF. STANDARDS & IMPURITIES

1 Others

01

02

03

04

05

06

07

08

09

01

02

02

03

03

04

04

05

05

06

06

07

07

08

08

01

01

02

03

04

05

06

07

08

09

10

01

02

03

04

05

06

07

08

09

01

02

03

04

05

06

07

01

02

03

04