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    INACTIVE PHARMA INGREDIENTS

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    01

    Kerry

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
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    Kerry

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    PEGS Boston Summit
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24820

    Submission : 2011-04-01

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    Suheung Capsule

    South Korea

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
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    Suheung Capsule

    South Korea

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    PEGS Boston Summit
    Not Confirmed
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15212

    Submission : 2000-12-27

    Status : Active

    Type : IV

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    03

    Seppic

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
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    Seppic

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    PEGS Boston Summit
    Not Confirmed
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12524

    Submission : 1997-06-02

    Status : Active

    Type : IV

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    04

    Seppic

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
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    Seppic

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    PEGS Boston Summit
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14031

    Submission : 1999-03-08

    Status : Active

    Type : IV

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    05

    Seppic

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
    arrow

    Seppic

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    PEGS Boston Summit
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17578

    Submission : 2004-07-30

    Status : Active

    Type : IV

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    06

    Seppic

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
    arrow

    Seppic

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    PEGS Boston Summit
    Not Confirmed
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26653

    Submission : 2012-09-28

    Status : Active

    Type : IV

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    07

    Seppic

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
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    Seppic

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    PEGS Boston Summit
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27914

    Submission : 2014-01-10

    Status : Active

    Type : IV

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    08

    SAMSUNG FINE CHEMICALS CO. LTD.

    South Korea

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
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    SAMSUNG FINE CHEMICALS CO. LTD.

    South Korea

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PEGS Boston Summit
    Not Confirmed
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25333

    Submission : 2011-09-16

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Qualicaps

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
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    Qualicaps

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    PEGS Boston Summit
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12900

    Submission : 1998-03-17

    Status : Active

    Type : IV

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    10

    Qualicaps

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
    arrow

    Qualicaps

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PEGS Boston Summit
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14765

    Submission : 2000-03-03

    Status : Active

    Type : IV

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    USDMF

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    01

    BIO International Convention
    Not Confirmed

    01

    Dah Feng Capsule Industry Co Ltd

    Taiwan
    arrow
    BIO International Convention
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19264

    Submission : 2006-03-14

    Status : Active

    Type : IV

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    02

    Capsugel Inc

    U.S.A

    USDMF

    arrow
    BIO International Convention
    Not Confirmed

    02

    Capsugel Inc

    U.S.A
    arrow
    BIO International Convention
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16964

    Submission : 2003-11-18

    Status : Inactive

    Type : IV

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    03

    Capsugel Inc

    U.S.A

    USDMF

    arrow
    BIO International Convention
    Not Confirmed

    03

    Capsugel Inc

    U.S.A
    arrow
    BIO International Convention
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15834

    Submission : 2002-01-31

    Status : Inactive

    Type : IV

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    04

    Capsugel Inc

    U.S.A

    USDMF

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    BIO International Convention
    Not Confirmed

    04

    Capsugel Inc

    U.S.A
    arrow
    BIO International Convention
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12730

    Submission : 1997-10-27

    Status : Inactive

    Type : IV

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    05

    Qualicaps Co Ltd

    Spain

    USDMF

    arrow
    BIO International Convention
    Not Confirmed

    05

    Qualicaps Co Ltd

    Spain
    arrow
    BIO International Convention
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12900

    Submission : 1998-03-17

    Status : Active

    Type : IV

    blank

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    06

    Qualicaps Europe Sau

    Spain

    USDMF

    arrow
    BIO International Convention
    Not Confirmed

    06

    Qualicaps Europe Sau

    Spain
    arrow
    BIO International Convention
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14765

    Submission : 2000-03-03

    Status : Active

    Type : IV

    blank

    Portfolio PDF

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    07

    Seppic Sa

    France

    USDMF

    arrow
    BIO International Convention
    Not Confirmed

    07

    Seppic Sa

    France
    arrow
    BIO International Convention
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17578

    Submission : 2004-07-30

    Status : Active

    Type : IV

    blank

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    08

    Seppic Sa

    France

    USDMF

    arrow
    BIO International Convention
    Not Confirmed

    08

    Seppic Sa

    France
    arrow
    BIO International Convention
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14031

    Submission : 1999-03-08

    Status : Active

    Type : IV

    blank

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    09

    Seppic Sa

    France

    USDMF

    arrow
    BIO International Convention
    Not Confirmed

    09

    Seppic Sa

    France
    arrow
    BIO International Convention
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12524

    Submission : 1997-06-02

    Status : Active

    Type : IV

    blank

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    10

    Suheung Co Ltd

    South Korea

    USDMF

    arrow
    BIO International Convention
    Not Confirmed

    10

    Suheung Co Ltd

    South Korea
    arrow
    BIO International Convention
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15212

    Submission : 2000-12-27

    Status : Active

    Type : IV

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    FINISHED DOSAGE FORMULATIONS

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    EXCIPIENTS BY APPLICATIONS

    Click here to find the perfect excipient manufacturers by their capabilities

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    01

    Novo Excipients

    India
    BIO International Convention
    Not Confirmed
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    02

    Qianhao Chemical (Hebei) Co., Ltd

    China
    BIO International Convention
    Not Confirmed
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    03

    Ideal Cures

    India
    BIO International Convention
    Not Confirmed
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    04

    Kima Chemical

    China
    BIO International Convention
    Not Confirmed
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    05

    The Dow Chemical Company

    U.S.A
    BIO International Convention
    Not Confirmed
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    06

    Kerry

    U.S.A
    BIO International Convention
    Not Confirmed
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    07

    Kerry

    U.S.A
    BIO International Convention
    Not Confirmed
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    08

    Kerry

    U.S.A
    BIO International Convention
    Not Confirmed
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    09

    Ideal Cures

    India
    BIO International Convention
    Not Confirmed
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    10

    Kerry

    U.S.A
    BIO International Convention
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    Excipient Market Overview: Clariant sets up its first PEG excipients facility in US; India harmonizes 22 excipient monographs

    Excipient Market Overview: Clariant sets up its first PEG excipients facility in US; India harmonizes 22 excipient monographs

    The market for pharmaceutical excipients — or inactive substances used in the production of drugs —  continued to witness significant transformation in the first quarter (Q1) of 2026. The rise of biologics, increasing demand for personalized medicine, and innovations in drug delivery systems are driving demand for a wider range of functional excipients. As a result, the pharmaceutical excipients market is estimated to grow at a compound annual growth rate (CAGR) of 5.75 percent, to exceed US$ 15.43 billion by 2034. Its size was estimated at US$ 9.31 billion in 2025. The North American market for excipients was estimated at US$ 3.1 billion in 2024 and is estimated to increase to US$ 5.66 billion by 2034. In comparison, the European market for pharmaceutical excipients was estimated at US$ 2.35 billion in 2024 and is predicted to reach around US$ 3.95 billion by 2034, while the Asia Pacific market stood at US$ 1.94 billion in 2024 and is projected to grow to US$ 3.65 billion by 2034.The sector remains highly competitive and fragmented. Major excipient providers include BASF, Roquette, Gangwal Healthcare, Croda International, DuPont, Seqens, SPI Pharma, Evonik, PMC Isochem, Pfanstiehl, Colorcon, Kewpie Corporation, ICE Pharma, Nanjing Well Pharmaceutical, Merck KGaA-owned MilliporeSigma, Minakem, Ashland Global and Nippon Fine Chemical.Clariant sets up its first PEG excipients facility in US; Croda opens greenfield facility in India Swiss specialty chemical company Clariant is expanding its Clear Lake (Texas) site to include GMP-compliant manufacturing of pharmaceutical-grade polyethylene glycol (PEG) excipients. This will improve availability and reliability for North American customers, with extended reach to Latin America. The multi-phase expansion addresses critical industry priorities around supply chain security, continuity, and responsiveness while demonstrating Clariant’s long-term strategic commitment to the US pharmaceutical market. This is the first Clariant facility in the US to manufacture PEG excipients for oral and topical applications.British specialty chemicals company Croda International has inaugurated a greenfield manufacturing facility in Dahej, India, that strengthens its ability to serve fast-growing markets in Asia. The new site represents a significant investment in India and will enhance Croda’s supply capabilities, improve responsiveness to customer demand, and support future growth in high-value sectors. Located in Gujarat, the facility benefits from strong logistics connectivity and is designed to serve both domestic customers and select export markets. It will support demand across Croda’s consumer care, life sciences, and industrial specialties sectors. Following the acquisition of IFF Pharma Solutions in 2025, French excipient company Roquette has introduced an expanded cosmetics portfolio under the Roquette Beauté brand. This portfolio integrates IFF Pharma Solutions’ ingredients — Methocel, Avicel, Aquacoat, Ethocel, and Polyox — with Roquette’s legacy range, while its core portfolio continues to include widely used pharmaceutical excipients. View Our Dashboard on Major Excipient Companies in 2026 (Free Excel Available)SPI Pharma-Anek Prayog, Ingredion-Univar ink distribution deals; DFE Pharma, Gericke launch CM platformIn February, US-based pharmaceutical excipient and ingredients company SPI Pharma announced a global distribution partnership with Indian pharmaceutical excipient manufacturer Anek Prayog. Under this agreement, SPI will exclusively sell, promote, and distribute Lubripharm Pro SSF, a next-generation sodium stearyl fumarate lubricant manufactured by Anek Prayog.The Ingredients + Specialties division of Univar Solutions was appointed as a distributor for Ingredion Pharma Solutions. The agreement includes distribution of Ingredion’s global pharmaceuticals portfolio and positions Univar as the exclusive distributor of pharmaceutical starches in the US and Canada. The partnership expands its pharmaceutical and nutraceutical excipient offerings, including binders, fillers, superdisintegrants, lubricants, and gelatin alternatives.German excipient solutions company DFE Pharma has launched a continuous manufacturing (CM) platform in collaboration with Switzerland-based Gericke Group to support formulation development, optimization, and lifecycle management. The platform integrates CM-ready excipients, a flexible evaluation environment, and multidisciplinary expertise to enable data-driven decisions from early development to commercial manufacturing.As part of this initiative, DFE Pharma has established CM capabilities at its C2F Center of Excellence in Hyderabad, featuring a Gericke Formulation Skid (GFS) in a non-GMP setup. This modular system enables rapid testing, process optimization, and practical assessment of continuous feeding and blending without impacting existing GMP operations, while supporting alignment with ICH Q13 (an international guideline on CM for drug substances and products).Gangwal Healthcare operates EXCiPACT-certified GMP facilities and offers a broad range of functional excipients, including co-processed blends like ProBlend, Starlose, Tyloxapole, and Microlose. Its excipients, including Solvostar (sodium starch glycolate) and LubMag-W (Magnesium Stearate, Sodium Lauryl Sulfate), support enhanced tablet disintegration and drug release. The company also provides taste-masking agents such as SucreX (sucralose) and CutCal (neotame), supporting the development of patient-friendly oral dosage forms. View Our Dashboard on Major Excipient Companies in 2026 (Free Excel Available)India harmonizes 22 excipient monographs; EMA updates TE guidelines for inhalation products Regulators are increasingly tightening requirements around excipients, as they are no longer treated as passive ingredients. They are being recognized as critical to product performance and therapeutic equivalence.India has introduced the Indian Pharmacopoeia 2026 with updated and harmonized standards for pharmaceutical ingredients, including 22 excipient monographs. These revisions align Indian standards more closely with global pharmacopoeias. For excipient manufacturers and drug formulators, this means stricter compliance expectations. In August, India had notified an amendment to the Drugs Rules, 1945 to mandate inclusion of qualitative details of excipients in drug labels through barcodes or QR codes from 2026.The European Medicines Agency (EMA) has issued updated guidelines on the pharmaceutical quality of inhalation and nasal medicines, as well as on demonstrating therapeutic equivalence (TE) of orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease. These guidelines require manufacturers to provide detailed information on the active substance, finished product composition, pharmaceutical development studies, and the control of excipients and other formulation components. Similar pharmaceutical quality requirements apply to nasal products under the pharmaceutical quality guideline.Excipients are becoming increasingly linked to manufacturing technologies. For instance, the US Food and Drug Administration (FDA) finalized its Advanced Manufacturing Technologies (AMT) Designation Program in 2024. This is expected to increase the need for excipients compatible with such technologies. View Our Dashboard on Major Excipient Companies in 2026 (Free Excel Available)Our view While the market for excipients is growing at a healthy pace, the ongoing conflict in the Middle East is disrupting pharmaceutical supply chains, with impacts now extending beyond APIs to critical excipients and packaging materials. Surging crude oil prices are driving up the cost of excipients, with key inputs like chloroform witnessing sharp price increases. In addition, disruptions in logistics are forcing drugmakers to reroute shipments through longer and more expensive routes due to closure of airports and certain sea routes. These developments will have a cascading effect on the pharmaceutical industry and its supply chain in the coming months.
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    Hydroxypropyl Methylcellulose (2 MT) API needed in India [ENA19499]
    A company that focuses on manufacturing & distribution of finished pellets formulations (ready to fill pellets) is looking for suppliers of Hydroxypropyl Methylcellulose (2 MT) API for commercial purposes. The suppliers must support this enquiry with CoA.
    11 May 2024

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    11 May 2024

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    11 May 2024

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    Various APIs needed in Russia [ENA08740]
    Bright Way, an import-export oriented company that deals in various pharmaceutical products is looking for suppliers of Various APIs. Interested suppliers can contact them via their email: o.chuiko@brightway.ru. 1. Olopatadine API 2. Timolol API 3. Dextran (500 kg) API 4. Norfloxacin (200 kg) API 5. Nafazoline (50 kg & 100 kg) API 6. Zinc Sulfate API 7. Tafluprost API 8. Benzyldimethyl Myristoilamine Propylammonium API 9. Bimatoprost API 10. Bromfenacum API 11. Picloxidine API 12. Tetryzoline API 13. Hypromellose API 14. Methylethylpiridinol API
    06 Oct 2020

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    06 Oct 2020

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    06 Oct 2020

    United_States_of_America.png
    Xylometazoline HCL and other APIs needed in the United States [ENA03473]
    A pharmaceutical company which innovates, formulates, creates and comarkets consumer brands is looking for suppliers of below products: 1. Xylometazoline HCL 2. Sodium Phosphate Dibasic, 7-Hydrate 3. Sodium Phosphate Monobasic, Monohydrate 4. Benzalkonium Chloride 50% Solution 5. Polyethylene Glycol 1450 6. Hypromellose 2910
    19 Feb 2019

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    19 Feb 2019

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    19 Feb 2019

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    Enquiry// Lidocaine HCl (100kg) of BP/EP grade and Hydroxypropyl methyl cellulose (1000kg) needed in Bangladesh [ENA01752]
    An intensively developing trading company in Bangladesh is looking for the suppliers of the Lidocaine HCl (100kg) of BP/EP grade and Hydroxypropyl methylcellulose (1000kg). Interested suppliers must support this enquiry with Certificate of Analysis (COA) and must contact Muhammad Harunur Rashid via E-mail: tareque_enterprises@ymail.com or Tel:++88-02-9569575/9550197, 9002267/ Whats App: 8801861222133.
    04 Sep 2018

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    04 Sep 2018

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    04 Sep 2018

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