Share This Page
Suppliers and packagers for generic pharmaceutical drug: VORINOSTAT
✉ Email this page to a colleague
VORINOSTAT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | ZOLINZA | vorinostat | CAPSULE;ORAL | 021991 | NDA | Merck Sharp & Dohme LLC | 0006-0568-40 | 120 CAPSULE in 1 BOTTLE (0006-0568-40) | 2006-10-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VORINOSTAT
Introduction
Vorinostat, marketed under the brand name Pivanex among others, is an investigational histone deacetylase (HDAC) inhibitor primarily studied for its potential in treating various cancers and neurological disorders. Although it remains primarily in clinical development phases, understanding its supplier landscape is crucial for stakeholders involved in research, manufacturing, and distribution. This comprehensive review explores the key suppliers for Vorinostat, covering active pharmaceutical ingredient (API) manufacturers, formulation providers, and distribution channels within the pharmaceutical supply chain.
Overview of Vorinostat
Vorinostat (also known as suberoylanilide hydroxamic acid, SAHA) was initially developed by Merck & Co. and later licensed to other companies for development and commercialization. As an epigenetic modifier, Vorinostat has gained interest for its therapeutic potential, especially in oncology. Its complex synthesis, regulatory status, and niche market influence supplier dynamics, making it pertinent to analyze the current supplier ecosystem.
Active Pharmaceutical Ingredient (API) Suppliers for Vorinostat
The foundation of any pharmaceutical supply chain lies in its API manufacturing. Vorinostat's synthesis involves multiple chemical steps requiring specialized manufacturing processes that ensure high purity and compliance with GMP standards.
1. Contract Manufacturing Organizations (CMOs) for Vorinostat API
a. Fujifilm Toyama Chemical Co., Ltd.
Fujifilm Toyama is known for synthesizing and supplying various epigenetic agents, including HDAC inhibitors, for preclinical and clinical development. Their expertise in complex small-molecule manufacturing positions them as a potential API supplier for Vorinostat under confidential agreements.
b. Zhejiang Hisun Pharmaceutical
An established Chinese CMO with capabilities for stereospecific and complex synthesis processes. Hisun has expanded its portfolio to include research chemicals for oncology drugs, including HDAC inhibitors, either directly or through partnership arrangements [[1]].
c. Jubilant Biosys (India)
This Indian CRO/CMO has facilities capable of GMP-grade small molecule synthesis, including custom synthesis and API manufacturing for compounds similar to Vorinostat. Their manufacturing includes process development, scale-up, and supply [[2]].
2. Big Pharma and Proprietary Suppliers
While Merck (now part of MSD) retains rights related to Vorinostat, proprietary manufacturing details remain confidential. Other major pharmaceutical firms with influence over HDAC inhibitor supply chains may supply intermediates or related compounds but typically do not publicly disclose API sources for Vorinostat.
Formulation and Finished Drug Product Manufacturers
Once APIs are secured, formulators package Vorinostat into dosage forms—mainly capsules or oral solutions—depending on clinical or commercial needs.
1. Specialized Contract Manufacturers
a. Catalent, Inc.
Catalent provides fill-finish services and formulation development for oral solid dosage forms. They possess regulatory-approved facilities capable of producing clinical trial supplies or commercial batches of drugs like Vorinostat.
b. Patheon (Thermo Fisher Scientific)
Patheon offers comprehensive cGMP manufacturing, including capsule filling and oral liquid formulation. They have experience working with epigenetic drugs, which may include Vorinostat during clinical phases [[3]].
2. In-House Manufacturing
Large research-based pharmaceutical companies developing Vorinostat may handle formulation internally to ensure tight control over quality during clinical trials, especially if the molecule remains investigational.
Distribution Channels and Logistics
Distribution of Vorinostat, whether as API or finished drug, involves strict adherence to regulatory standards to ensure drug integrity.
1. Global API Distributors
Major pharmaceutical API wholesalers such as Alfa Aesar (Thermo Fisher), Sigma-Aldrich (Merck), and **Ban<|vq_hbr_audio_5460|><|vq_hbr_audio_16129|><|vq_hbr_audio_15300|><|vq_hbr_audio_10328|><|vq_hbr_audio_130|><|vq_hbr_audio_10788|><|vq_hbr_audio_12449|><|vq_hbr_audio_2967|><|vq_hbr_audio_1627|><|vq_hbr_audio_13202|><|vq_hbr_audio_257|><|vq_hbr_audio_6954|><|vq_hbr_audio_8425|><|vq_hbr_audio_13655|><|vq_hbr_audio_6199|><|vq_hbr_audio_3702|><|vq_hbr_audio_10094|><|vq_hbr_audio_15168|><|vq_hbr_audio_1465|><|vq_hbr_audio_14787|><|vq_hbr_audio_2806|><|vq_hbr_audio_1247|><|vq_hbr_audio_4887|><|vq_hbr_audio_6122|><|vq_hbr_audio_14980|><|vq_hbr_audio_16243|><|vq_hbr_audio_1749|><|vq_hbr_audio_8692|><|vq_hbr_audio_2834|><|vq_hbr_audio_9618|><|vq_hbr_audio_12644|><|vq_hbr_audio_6442|><|vq_hbr_audio_16155|><|vq_hbr_audio_13819|><|vq_hbr_audio_14017|><|vq_hbr_audio_6718|><|vq_hbr_audio_12425|><|vq_hbr_audio_6255|><|vq_hbr_audio_1083|><|vq_hbr_audio_1397|><|vq_hbr_audio_1935|><|vq_hbr_audio_15258|><|vq_hbr_audio_6500|><|vq_hbr_audio_8202|><|vq_hbr_audio_10867|><|vq_hbr_audio_4710|><|vq_hbr_audio_16041|><|vq_hbr_audio_3091|><|vq_hbr_audio_14099|><|vq_hbr_audio_8291|><|vq_hbr_audio_6640|><|vq_hbr_audio_3414|><|vq_hbr_audio_2723|><|vq_hbr_audio_3580|><|vq_hbr_audio_2574|><|vq_hbr_audio_2550|><|vq_hbr_audio_7707|><|vq_hbr_audio_12992|><|vq_hbr_audio_16163|><|vq_hbr_audio_13570|><|vq_hbr_audio_387|><|vq_hbr_audio_12627|><|vq_hbr_audio_7922|><|vq_hbr_audio_12224|><|vq_hbr_audio_16119|><|vq_hbr_audio_10759|><|vq_hbr_audio_4568|><|vq_hbr_audio_3445|><|vq_hbr_audio_5204|><|vq_hbr_audio_3587|><|vq_hbr_audio_10613|><|vq_hbr_audio_10905|><|vq_hbr_audio_497|><|vq_hbr_audio_1829|><|vq_hbr_audio_3326|><|vq_hbr_audio_1283|><|vq_hbr_audio_998|><|vq_hbr_audio_10722|><|vq_hbr_audio_2698|><|vq_hbr_audio_14666|><|vq_hbr_audio_6956|><|vq_hbr_audio_5574|><|vq_hbr_audio_150|><|vq_hbr_audio_13787|><|vq_hbr_audio_5190|><|vq_hbr_audio_716|><|vq_hbr_audio_15268|><|vq_hbr_audio_2583|><|vq_hbr_audio_1990|><|vq_hbr_audio_220|><|vq_hbr_audio_12624|><|vq_hbr_audio_8471|><|vq_hbr_audio_3444|><|vq_hbr_audio_14768|><|vq_hbr_audio_6513|><|vq_hbr_audio_9942|><|vq_hbr_audio_11648|><|vq_hbr_audio_1633|><|vq_hbr_audio_4890|><|vq_hbr_audio_14139|><|vq_hbr_audio_8573|><|vq_hbr_audio_14061|><|vq_hbr_audio_9735|><|vq_hbr_audio_5521|><|vq_hbr_audio_779|><|vq_hbr_audio_8128|><|vq_hbr_audio_14113|><|vq_hbr_audio_14752|><|vq_hbr_audio_12404|><|vq_hbr_audio_15075|><|vq_hbr_audio_16264|><|vq_hbr_audio_6010|><|vq_hbr_audio_1744|><|vq_hbr_audio_4206|><|vq_hbr_audio_13276|><|vq_hbr_audio_3803|><|vq_hbr_audio_15924|><|vq_hbr_audio_13146|><|vq_hbr_audio_54|><|vq_hbr_audio_13873|><|vq_hbr_audio_3818|><|vq_hbr_audio_5754|><|vq_hbr_audio_4058|><|vq_hbr_audio_3593|><|vq_hbr_audio_10238|><|vq_hbr_audio_15986|><|vq_hbr_audio_2162|><|vq_hbr_audio_559|><|vq_hbr_audio_15776|><|vq_hbr_audio_15129|><|vq_hbr_audio_5986|><|vq_hbr_audio_1656|><|vq_hbr_audio_6299|><|vq_hbr_audio_11321|><|vq_hbr_audio_6942|><|vq_hbr_audio_3854|><|vq_hbr_audio_2304|><|vq_hbr_audio_954|><|vq_hbr_audio_8728|><|vq_hbr_audio_11588|><|vq_hbr_audio_11628|><|vq_hbr_audio_5765|><|vq_hbr_audio_10996|><|vq_hbr_audio_2111|><|vq_hbr_audio_990|><|vq_hbr_audio_1392|><|vq_hbr_audio_5006|><|vq_hbr_audio_14112|><|vq_hbr_audio_12611|><|vq_hbr_audio_822|><|vq_hbr_audio_1579|><|vq_hbr_audio_89|><|vq_hbr_audio_6931|><|vq_hbr_audio_4866|><|vq_hbr_audio_4150|><|vq_hbr_audio_13202|><|vq_hbr_audio_560|><|vq_hbr_audio_15589|><|vq_hbr_audio_12563|><|vq_hbr_audio_13434|><|vq_hbr_audio_11430|><|vq_hbr_audio_6064|><|vq_hbr_audio_12978|><|vq_hbr_audio_15131|><|vq_hbr_audio_12976|><|vq_hbr_audio_15131|><|vq_hbr_audio_12216|><|vq_hbr_audio_10249|><|vq_hbr_audio_699|><|vq_hbr_audio_12691|><|vq_hbr_audio_10666|><|vq_hbr_audio_12341|><|vq_hbr_audio_12493|><|vq_hbr_audio_13207|><|vq_hbr_audio_15509|><|vq_hbr_audio_5458|><|vq_hbr_audio_11912|><|vq_hbr_audio_1242|><|vq_hbr_audio_5852|><|vq_hbr_audio_15048|><|vq_hbr_audio_12804|><|vq_hbr_audio_8026|><|vq_hbr_audio_14110|><|vq_hbr_audio_11828|><|vq_hbr_audio_8637|><|vq_hbr_audio_339|><|vq_hbr_audio_16264|><|vq_hbr_audio_14942|><|vq_hbr_audio_9899|><|vq_hbr_audio_14601|><|vq_hbr_audio_11325|><|vq_hbr_audio_16105|><|vq_hbr_audio_12556|><|vq_hbr_audio_2964|><|vq_hbr_audio_3992|><|vq_hbr_audio_13122|><|vq_hbr_audio_9295|><|vq_hbr_audio_11088|><|vq_hbr_audio_2364|><|vq_hbr_audio_796|><|vq_hbr_audio_14863|><|vq_hbr_audio_6797|><|vq_hbr_audio_6737|><|vq_hbr_audio_13756|><|vq_hbr_audio_9398|><|vq_hbr_audio_15278|><|vq_hbr_audio_12490|><|vq_hbr_audio_6819|><|vq_hbr_audio_13962|><|vq_hbr_audio_12954|><|vq_hbr_audio_2007|><|vq_hbr_audio_11386|><|vq_hbr_audio_12972|><|vq_hbr_audio_1130|><|vq_hbr_audio_1143|><|vq_hbr_audio_13766|><|vq_hbr_audio_8827|><|vq_hbr_audio_13286|><|vq_hbr_audio_12726|><|vq_hbr_audio_7005|><|vq_hbr_audio_11093|><|vq_hbr_audio_12291|><|vq_hbr_audio_16021|><|vq_hbr_audio_16079|><|vq_hbr_audio_5663|><|vq_hbr_audio_6737|><|vq_hbr_audio_1992|><|vq_hbr_audio_11649|><|vq_hbr_audio_3700|><|vq_hbr_audio_3899|><|vq_hbr_audio_13458|><|vq_hbr_audio_16333|><|vq_hbr_audio_8420|><|vq_hbr_audio_10910|><|vq_hbr_audio_12830|><|vq_hbr_audio_10352|><|vq_hbr_audio_15804|><|vq_hbr_audio_5215|><|vq_hbr_audio_15116|><|vq_hbr_audio_16183|><|vq_hbr_audio_10059|><|vq_hbr_audio_10502|><|vq_hbr_audio_15774|><|vq_hbr_audio_8452|><|vq_hbr_audio_10974|><|vq_hbr_audio_5687|><|vq_hbr_audio_10974|><|vq_hbr_audio_7164|><|vq_hbr_audio_10456|><|vq_hbr_audio_139|><|vq_hbr_audio_15154|><|vq_hbr_audio_8537|><|vq_hbr_audio_5023|><|vq_hbr_audio_585|><|vq_hbr_audio_12664|><|vq_hbr_audio_10328|><|vq_hbr_audio_13252|><|vq_hbr_audio_5895|><|vq_hbr_audio_5696|><|vq_hbr_audio_8286|><|vq_hbr_audio_16338|><|vq_hbr_audio_10691|><|vq_hbr_audio_5720|><|vq_hbr_audio_11946|><|vq_hbr_audio_6610|><|vq_hbr_audio_7671|><|vq_hbr_audio_15473|><|vq_hbr_audio_5203|><|vq_hbr_audio_6956|><|vq_hbr_audio_758|><|vq_hbr_audio_15278|><|vq_hbr_audio_15143|><|vq_hbr_audio_10946|><|vq_hbr_audio_6721|><|vq_hbr_audio_6042|><|vq_hbr_audio_3224|><|vq_hbr_audio_14103|><|vq_hbr_audio_15659|><|vq_hbr_audio_4734|><|vq_hbr_audio_15784|><|vq_hbr_audio_32|><|vq_hbr_audio_3388|><|vq_hbr_audio_8692|><|vq_hbr_audio_1841|><|vq_hbr_audio_14680|><|vq_hbr_audio_15761|><|vq_hbr_audio_1839|><|vq_hbr_audio_8637|><|vq_hbr_audio_2704|><|vq_hbr_audio_6614|><|vq_hbr_audio_7206|><|vq_hbr_audio_8923|><|vq_hbr_audio_14170|><|vq_hbr_audio_10737|><|vq_hbr_audio_10772|><|vq_hbr_audio_8734|><|vq_hbr_audio_2263|><|vq_hbr_audio_4816|><|vq_hbr_audio_13310|><|vq_hbr_audio_7896|><|vq_hbr_audio_10008|><|vq_hbr_audio_2455|><|vq_hbr_audio_7344|><|vq_hbr_audio_11943|><|vq_hbr_audio_5093|><|vq_hbr_audio_5894|><|vq_hbr_audio_14780|><|vq_hbr_audio_3644|><|vq_hbr_audio_15776|><|vq_hbr_audio_3274|><|vq_hbr_audio_8424|><|vq_hbr_audio_2094|><|vq_hbr_audio_15169|><|vq_hbr_audio_3919|><|vq_hbr_audio_652|><|vq_hbr_audio_15975|><|vq_hbr_audio_4923|><|vq_hbr_audio_12581|><|vq_hbr_audio_7119|><|vq_hbr_audio_14201|><|vq_hbr_audio_3523|><|vq_hbr_audio_8463|><|vq_hbr_audio_304|><|vq_hbr_audio_4704|><|vq_hbr_audio_904|><|vq_hbr_audio_4531|><|vq_hbr_audio_13354|><|vq_hbr_audio_15330|><|vq_hbr_audio_8380|><|vq_hbr_audio_13546|><|vq_hbr_audio_10111|><|vq_hbr_audio_12639|><|vq_hbr_audio_585|><|vq_hbr_audio_8236|><|vq_hbr_audio_1257|><|vq_hbr_audio_4624|><|vq_hbr_audio_769|><|vq_hbr_audio_5784|><|vq_hbr_audio_7498|><|vq_hbr_audio_2035|><|vq_hbr_audio_13140|><|vq_hbr_audio_6752|><|vq_hbr_audio_2190|><|vq_hbr_audio_2622|><|vq_hbr_audio_5124|><|vq_hbr_audio_902|><|vq_hbr_audio_3091|><|vq_hbr_audio_5734|><|vq_hbr_audio_3579|><|vq_hbr_audio_11221|><|vq_hbr_audio_11157|><|vq_hbr_audio_3391|><|vq_hbr_audio_11889|><|vq_hbr_audio_319|><|vq_hbr_audio_4260|><|vq_hbr_audio_11544|><|vq_hbr_audio_8222|><|vq_hbr_audio_6224|><|vq_hbr_audio_4624|><|vq_hbr_audio_2324|><|vq_hbr_audio_10484|><|vq_hbr_audio_12287|><|vq_hbr_audio_4357|><|vq_hbr_audio_579|><|vq_hbr_audio_1827|><|vq_hbr_audio_912|><|vq_hbr_audio_14762|><|vq_hbr_audio_7190|><|vq_hbr_audio_12452|><|vq_hbr_audio_11385|><|vq_hbr_audio_692|><|vq_hbr_audio_12003|><|vq_hbr_audio_4144|><|vq_hbr_audio_7012|><|vq_hbr_audio_1212|><|vq_hbr_audio_16204|><|vq_hbr_audio_11221|><|vq_hbr_audio_8608|><|vq_hbr_audio_3123|><|vq_hbr_audio_14368|><|vq_hbr_audio_5417|><|vq_hbr_audio_10204|><|vq_hbr_audio_1502|><|vq_hbr_audio_7377|><|vq_hbr_audio_4552|><|vq_hbr_audio_5030|><|vq_hbr_audio_12909|><|vq_hbr_audio_8155|><|vq_hbr_audio_170|><|vq_hbr_audio_5982|><|vq_hbr_audio_2613|><|vq_hbr_audio_710|><|vq_hbr_audio_4411|><|vq_hbr_audio_1578|><|vq_hbr_audio_15158|><|vq_hbr_audio_1833|><|vq_hbr_audio_14085|><|vq_hbr_audio_441|><|vq_hbr_audio_11950|><|vq_hbr_audio_8528|><|vq_hbr_audio_12901|><|vq_hbr_audio_16344|><|vq_hbr_audio_7713|><|vq_hbr_audio_15151|><|vq_hbr_audio_6330|><|vq_hbr_audio_4934|><|vq_hbr_audio_707|><|vq_hbr_audio_15933|><|vq_hbr_audio_3561|><|vq_hbr_audio_1240|><|vq_hbr_audio_3759|><|vq_hbr_audio_3500|><|vq_hbr_audio_5922|><|vq_hbr_audio_62|><|vq_hbr_audio_6250|><|vq_hbr_audio_14102|><|vq_hbr_audio_15983|><|vq_hbr_audio_7670|><|vq_hbr_audio_863|><|vq_hbr_audio_13456|><|vq_hbr_audio_7770|><|vq_hbr_audio_14409|><|vq_hbr_audio_11253|><|vq_hbr_audio_15829|><|vq_hbr_audio_10351|><|vq_hbr_audio_681|><|vq_hbr_audio_14823|><|vq_hbr_audio_8730|><|vq_hbr_audio_5354|><|vq_hbr_audio_10211|><|vq_hbr_audio_12529|><|vq_hbr_audio_2844|><|vq_hbr_audio_8710|><|vq_hbr_audio_3519|><|vq_hbr_audio_3591|><|vq_hbr_audio_6632|><|vq_hbr_audio_11236|><|vq_hbr_audio_6827|><|vq_hbr_audio_8872|><|vq_hbr_audio_11589|><|vq_hbr_audio_15173|><|vq_hbr_audio_5603|><|vq_hbr_audio_4243|><|vq_hbr_audio_3416|><|vq_hbr_audio_16131|><|vq_hbr_audio_1277|><|vq_hbr_audio_14807|><|vq_hbr_audio_4810|><|vq_hbr_audio_2225|><|vq_hbr_audio_6690|><|vq_hbr_audio_12229|><|vq_hbr_audio_8607|><|vq_hbr_audio_4694|><|vq_hbr_audio_3323|><|vq_hbr_audio_7827|><|vq_hbr_audio_3148|><|vq_hbr_audio_12253|><|vq_hbr_audio_5405|><|vq_hbr_audio_10404|><|vq_hbr_audio_241|><|vq_hbr_audio_14884|><|vq_hbr_audio_9440|><|vq_hbr_audio_15045|><|vq_hbr_audio_11312|><|vq_hbr_audio_1837|><|vq_hbr_audio_14422|><|vq_hbr_audio_5594|><|vq_hbr_audio_13321|><|vq_hbr_audio_849|><|vq_hbr_audio_684|><|vq_hbr_audio_14721|><|vq_hbr_audio_12167|><|vq_hbr_audio_12589|><|vq_hbr_audio_1835|><|vq_hbr_audio_12987|><|vq_hbr_audio_12528|><|vq_hbr_audio_1344|><|vq_hbr_audio_8533|><|vq_hbr_audio_10735|><|vq_hbr_audio_6019|><|vq_hbr_audio_4452|><|vq_hbr_audio_649|><|vq_hbr_audio_12116|><|vq_hbr_audio_4214|><|vq_hbr_audio_7976|><|vq_hbr_audio_8440|><|vq_hbr_audio_12543|><|vq_hbr_audio_16088|><|vq_hbr_audio_6748|><|vq_hbr_audio_1560|><|vq_hbr_audio_132|><|vq_hbr_audio_9510|><|vq_hbr_audio_4837|><|vq_hbr_audio_12713|><|vq_hbr_audio_8737|><|vq_hbr_audio_6580|><|vq_hbr_audio_5932|><|vq_hbr_audio_978|><|vq_hbr_audio_10868|><|vq_hbr_audio_11231|><|vq_hbr_audio_1153|><|vq_hbr_audio_13800|><|vq_hbr_audio_5744|><|vq_hbr_audio_7337|><|vq_hbr_audio_14160|><|vq_hbr_audio_12960|><|vq_hbr_audio_5049|><|vq_hbr_audio_7754|><|vq_hbr_audio_795|><|vq_hbr_audio_16196|><|vq_hbr_audio_887|><|vq_hbr_audio_12829|><|vq_hbr_audio_13693|><|vq_hbr_audio_3359|><|vq_hbr_audio_5664|><|vq_hbr_audio_2952|><|vq_hbr_audio_14250|><|vq_hbr_audio_11727|><|vq_hbr_audio_15575|><|vq_hbr_audio_1032|><|vq_hbr_audio_14190|><|vq_hbr_audio_833|><|vq_hbr_audio_8559|><|vq_hbr_audio_12069|><|vq_hbr_audio_4147|><|vq_hbr_audio_6838|><|vq_hbr_audio_5572|><|vq_hbr_audio_8822|><|vq_hbr_audio_16235|><|vq_hbr_audio_13573|><|vq_hbr_audio_6985|><|vq_hbr_audio_3732|><|vq_hbr_audio_5579|><|vq_hbr_audio_2008|><|vq_hbr_audio_11894|><|vq_hbr_audio_585|><|vq_hbr_audio_1364|><|vq_hbr_audio_162|><|vq_hbr_audio_13484|><|vq_hbr_audio_12865|><|vq_hbr_audio_2459|><|vq_hbr_audio_6697|><|vq_hbr_audio_9024|><|vq_hbr_audio_7573|><|vq_hbr_audio_9778|><|vq_hbr_audio_12292|><|vq_hbr_audio_10386|><|vq_hbr_audio_11210|><|vq_hbr_audio_6149|><|vq_hbr_audio_13584|><|vq_hbr_audio_11256|><|vq_hbr_audio_14178|><|vq_hbr_audio_14135|><|vq_hbr_audio_2716|><|vq_hbr_audio_11385|><|vq_hbr_audio_9180|><|vq_hbr_audio_11597|><|vq_hbr_audio_8824|><|vq_hbr_audio_3237|><|vq_hbr_audio_12413|><|vq_hbr_audio_6047|><|vq_hbr_audio_15283|><|vq_hbr_audio_715|><|vq_hbr_audio_14100|><|vq_hbr_audio_338|><|vq_hbr_audio_8644|><|vq_hbr_audio_7670|><|vq_hbr_audio_12965|><|vq_hbr_audio_2439|><|vq_hbr_audio_2454|><|vq_hbr_audio_869|><|vq_hbr_audio_12863|><|vq_hbr_audio_7681|><|vq_hbr_audio_3913|><|vq_hbr_audio_7549|><|vq_hbr_audio_2990|><|vq_hbr_audio_11339|><|vq_hbr_audio_1932|><|vq_hbr_audio_13088|><|vq_hbr_audio_652|><|vq_hbr_audio_11265|><|vq_hbr_audio_897|><|vq_hbr_audio_833|><|vq_hbr_audio_10818|><|vq_hbr_audio_6081|><|vq_hbr_audio_15474|><|vq_hbr_audio_16183|><|vq_hbr_audio_5752|><|vq_hbr_audio_6247|><|vq_hbr_audio_10605|><|vq_hbr_audio_9652|><|vq_hbr_audio_6|><|vq_hbr_audio_10707|><|vq_hbr_audio_14587|><|vq_hbr_audio_5888|><|vq_hbr_audio_5889|><|vq_hbr_audio_170|><|vq_hbr_audio_176|><|vq_hbr_audio_8980|><|vq_hbr_audio_517|><|vq_hbr_audio_5404|><|vq_hbr_audio_7271|><|vq_hbr_audio_2763|><|vq_hbr_audio_10648|><|vq_hbr_audio_10366|><|vq_hbr_audio_237|><|vq_hbr_audio_2470|><|vq_hbr_audio_13618|><|vq_hbr_audio_3771|><|vq_hbr_audio_11937|><|vq_hbr_audio_13321|><|vq_hbr_audio_7377|><|vq_hbr_audio_11556|><|vq_hbr_audio_14441|><|vq_hbr_audio_5660|><|vq_hbr_audio_5854|><|vq_hbr_audio_1407|><|vq_hbr_audio_10536|><|vq_hbr_audio_11407|><|vq_hbr_audio_16288|><|vq_hbr_audio_749|><|vq_hbr_audio_16007|><|vq_hbr_audio_3042|><|vq_hbr_audio_13200|><|vq_hbr_audio_882|><|vq_hbr_audio_10055|><|vq_hbr_audio_4482|><|vq_hbr_audio_12365|><|vq_hbr_audio_8876|><|vq_hbr_audio_4372|><|vq_hbr_audio_13044|><|vq_hbr_audio_67|><|vq_hbr_audio_7995|><|vq_hbr_audio_10698|><|vq_hbr_audio_6535|><|vq_hbr_audio_5714|><|vq_hbr_audio_2047|><|vq_hbr_audio_12291|><|vq_hbr_audio_721|><|vq_hbr_audio_6650|><|vq_hbr_audio_15050|><|vq_hbr_audio_6607|><|vq_hbr_audio_7820|><|vq_hbr_audio_15001|><|vq_hbr_audio_6524|><|vq_hbr_audio_8054|><|vq_hbr_audio_4739|><|vq_hbr_audio_11927|><|vq_hbr_audio_5672|><|vq_hbr_audio_13748|><|vq_hbr_audio_6322|><|vq_hbr_audio_253|><|vq_hbr_audio_14637|><|vq_hbr_audio_5143|><|vq_hbr_audio_13556|><|vq_hbr_audio_3543|><|vq_hbr_audio_15746|><|vq_hbr_audio_13257|><|vq_hbr_audio_8380|><|vq_hbr_audio_398|><|vq_hbr_audio_6497|><|vq_hbr_audio_5595|><|vq_hbr_audio_4654|><|vq_hbr_audio_4054|><|vq_hbr_audio_11940|><|vq_hbr_audio_13827|><|vq_hbr_audio_5722|><|vq_hbr_audio_2066|><|vq_hbr_audio_7326|><|vq_hbr_audio_2920|><|vq_hbr_audio_10907|><|vq_hbr_audio_13542|><|vq_hbr_audio_7654|><|vq_hbr_audio_8894|><|vq_hbr_audio_9903|><|vq_hbr_audio_12890|><|vq_hbr_audio_4912|><|vq_hbr_audio_9662|><|vq_hbr_audio_8377|><|vq_hbr_audio_11709|><|vq_hbr_audio_6032|><|vq_hbr_audio_11935|><|vq_hbr_audio_11573|><|vq_hbr_audio_2236|><|vq_hbr_audio_1735|><|vq_hbr_audio_3672|><|vq_hbr_audio_13822|><|vq_hbr_audio_1433|><|vq_hbr_audio_3786|><|vq_hbr_audio_9942|><|vq_hbr_audio_14166|><|vq_hbr_audio_6076|><|vq_hbr_audio_12555|><|vq_hbr_audio_8220|><|vq_hbr_audio_7865|><|vq_hbr_audio_6724|><|vq_hbr_audio_7365|><|vq_hbr_audio_2474|><|vq_hbr_audio_4744|><|vq_hbr_audio_11602|><|vq_hbr_audio_3994|><|vq_hbr_audio_13777|><|vq_hbr_audio_943|><|vq_hbr_audio_16362|><|vq_hbr_audio_5911|><|vq_hbr_audio_2116|><|vq_hbr_audio_10645|><|vq_hbr_audio_5910|><|vq_hbr_audio_11839|><|vq_hbr_audio_2734|><|vq_hbr_audio_268|><|vq_hbr_audio_15266|><|vq_hbr_audio_7512|><|vq_hbr_audio_4584|><|vq_hbr_audio_2144|><|vq_hbr_audio_12459|><|vq_hbr_audio_1937|><|vq_hbr_audio_2462|><|vq_hbr_audio_2012|><|vq_hbr_audio_12699|><|vq_hbr_audio_4577|><|vq_hbr_audio_11415|><|vq_hbr_audio_407|><|vq_hbr_audio_9662|><|vq_hbr_audio_4486|><|vq_hbr_audio_6564|><|vq_hbr_audio_1372|><|vq_hbr_audio_6879|><|vq_hbr_audio_10249|><|vq_hbr_audio_6512|><|vq_hbr_audio_6658|><|vq_hbr_audio_11241|><|vq_hbr_audio_6754|><|vq_hbr_audio_8824|><|vq_hbr_audio_8824|><|vq_hbr_audio_15655|><|vq_hbr_audio_13755|><|vq_hbr_audio_12101|><|vq_hbr_audio_1029|><|vq_hbr_audio_12316|><|vq_hbr_audio_8747|><|vq_hbr_audio_15508|><|vq_hbr_audio_11256|><|vq_hbr_audio_5562|><|vq_hbr_audio_832|><|vq_hbr_audio_3574|><|vq_hbr_audio_7913|><|vq_hbr_audio_12391|><|vq_hbr_audio_6823|><|vq_hbr_audio_11837|><|vq_hbr_audio_8830|><|vq_hbr_audio_10735|><|vq_hbr_audio_7780|><|vq_hbr_audio_3596|><|vq_hbr_audio_4418|><|vq_hbr_audio_3937|><|vq_hbr_audio_3443|><|vq_hbr_audio_8991|><|vq_hbr_audio_10489|><|vq_hbr_audio_4298|><|vq_hbr_audio_6879|><|vq_hbr_audio_10309|><|vq_hbr_audio_15465|><|vq_hbr_audio_9094|><|vq_hbr_audio_9020|><|vq_hbr_audio_11382|><|vq_hbr_audio_405|><|vq_hbr_audio_12340|><|vq_hbr_audio_3964|><|vq_hbr_audio_10904|><|vq_hbr_audio_2304|><|vq_hbr_audio_8635|><|vq_hbr_audio_14823|><|vq_hbr_audio_4326|><|vq_hbr_audio_4561|><|vq_hbr_audio_7010|><|vq_hbr_audio_10830|><|vq_hbr_audio_13190|><|vq_hbr_audio_1124|><|vq_hbr_audio_3786|><|vq_hbr_audio_7641|><|vq_hbr_audio_1695|><|vq_hbr_audio_12781|><|vq_hbr_audio_6843|><|vq_hbr_audio_3684|><|vq_hbr_audio_455|><|vq_hbr_audio_15021|><|vq_hbr_audio_368|><|vq_hbr_audio_9210|><|vq_hbr_audio_5194|><|vq_hbr_audio_2460|><|vq_hbr_audio_506|><|vq_hbr_audio_14584|><|vq_hbr_audio_13158|><|vq_hbr_audio_1864|><|vq_hbr_audio_7129|><|vq_hbr_audio_15590|><|vq_hbr_audio_11125|><|vq_hbr_audio_14333|><|vq_hbr_audio_8230|><|vq_hbr_audio_3054|><|vq_hbr_audio_10927|><|vq_hbr_audio_11766|><|vq_hbr_audio_9514|><|vq_hbr_audio_8830|><|vq_hbr_audio_775|><|vq_hbr_audio_8340|><|vq_hbr_audio_74|><|vq_hbr_audio_12263|><|vq_hbr_audio_15253|><|vq_hbr_audio_12354|><|vq_hbr_audio_1572|><|vq_hbr_audio_13416|><|vq_hbr_audio_15983|><|vq_hbr_audio_8354|><|vq_hbr_audio_5645|><|vq_hbr_audio_11940|><|vq_hbr_audio_9042|><|vq_hbr_audio_282|><|vq_hbr_audio_7453|><|vq_hbr_audio_6356|><|vq_hbr_audio_533|><|vq_hbr_audio_3912|><|vq_hbr_audio_3012|><|vq_hbr_audio_7393|><|vq_hbr_audio_10192|><|vq_hbr_audio_16272|><|vq_hbr_audio_5294|><|vq_hbr_audio_9020|><|vq_hbr_audio_5722|><|vq_hbr_audio_10984|><|vq_hbr_audio_10769|><|vq_hbr_audio_12033|><|vq_hbr_audio_1238|><|vq_hbr_audio_12671|><|vq_hbr_audio_7690|><|vq_hbr_audio_5984|><|vq_hbr_audio_13851|><|vq_hbr_audio_14136|><|vq_hbr_audio_15384|><|vq_hbr_audio_11993|><|vq_hbr_audio_4773|><|vq_hbr_audio_13751|><|vq_hbr_audio_6741|><|vq_hbr_audio_7088|><|vq_hbr_audio_1661|><|vq_hbr_audio_8844|><|vq_hbr_audio_3850|><|vq_hbr_audio_3231|><|vq_hbr_audio_5555|><|vq_hbr_audio_2314|><|vq_hbr_audio_1232|><|vq_hbr_audio_1820|><|vq_hbr_audio_7406|><|vq_hbr_audio_8615|><|vq_hbr_audio_12501|><|vq_hbr_audio_12264|><|vq_hbr_audio_12780|><|vq_hbr_audio_2438|><|vq_hbr_audio_6704|><|vq_hbr_audio_12383|><|vq_hbr_audio_12803|><|vq_hbr_audio_15887|><|vq_hbr_audio_2472|><|vq_hbr_audio_2611|><|vq_hbr_audio_3563|><|vq_hbr_audio_7874|><|vq_hbr_audio_11307|><|vq_hbr_audio_13246|><|vq_hbr_audio_4927|><|vq_hbr_audio_13779|><|vq_hbr_audio_11309|><|vq_hbr_audio_5038|><|vq_hbr_audio_10563|><|vq_hbr_audio_13234|><|vq_hbr_audio_1151|><|vq_hbr_audio_5750|><|vq_hbr_audio_6311|><|vq_hbr_audio_9322|><|vq_hbr_audio_12444|><|vq_hbr_audio_3854|><|vq_hbr_audio_3034|><|vq_hbr_audio_11907|><|vq_hbr_audio_12029|><|vq_hbr_audio_9424|><|vq_hbr_audio_13756|><|vq_hbr_audio_304|><|vq_hbr_audio_12673|><|vq_hbr_audio_15721|><|vq_hbr_audio_8610|><|vq_hbr_audio_6280|><|vq_hbr_audio_4494|><|vq_hbr_audio_13764|><|vq_hbr_audio_1590|><|vq_hbr_audio_10154|><|vq_hbr_audio_6681|><|vq_hbr_audio_2537|><|vq_hbr_audio_12408|><|vq_hbr_audio_3360|><|vq_hbr_audio_954|><|vq_hbr_audio_12802|><|vq_hbr_audio_2458|><|vq_hbr_audio_8603|><|vq_hbr_audio_1389|><|vq_hbr_audio_12901|><|vq_hbr_audio_2693|><|vq_hbr_audio_6300|><|vq_hbr_audio_16362|><|vq_hbr_audio_7918|><|vq_hbr_audio_6900|><|vq_hbr_audio_1949|><|vq_hbr_audio_1512|><|vq_hbr_audio_2445|><|vq_hbr_audio_13777|><|vq_hbr_audio_10760|><|vq_hbr_audio_7718|><|vq_hbr_audio_9398|><|vq_hbr_audio_9970|><|vq_hbr_audio_5903|><|vq_hbr_audio_8597|><|vq_hbr_audio_7313|><|vq_hbr_audio_8322|><|vq_hbr_audio_3544|><|vq_hbr_audio_11463|><|vq_hbr_audio_14466|><|vq_hbr_audio_2140|><|vq_hbr_audio_10725|><|vq_hbr_audio_14742|><|vq_hbr_audio_16090|><|vq_hbr_audio_749|><|vq_hbr_audio_3986|><|vq_hbr_audio_8256|><|vq_hbr_audio_4941|><|vq_hbr_audio_157|><|vq_hbr_audio_15143|><|vq_hbr_audio_6483|><|vq_hbr_audio_13321|><|vq_hbr_audio_1910|><|vq_hbr_audio_21|><|vq_hbr_audio_12251|><|vq_hbraudio arbiters of sustainability for a drug company, Mazhar et al. highlight that “a significant challenge for the sector has been the reliance on patent protections which have limited early access and affordability for medicines” [1].
In this context, potential Vorinostat suppliers are mainly contract manufacturing organizations (CMOs) capable of scaling up production for clinical trial and commercial use, with an emphasis on quality and regulatory compliance. Simultaneously, the emerging landscape of pharmaceutical ingredients is increasingly diversified, with key suppliers in North America, Europe, and Asia.
Key API Suppliers in the Global Landscape
The API supply chain for Vorinostat remains somewhat opaque due to confidentiality agreements, but some players and regions dominate this space. The synthesis of Vorinostat requires expertise in chemical processes involving hydroxamic acids and complex purification steps.
a. Chinese and Indian CMOs
Chinese and Indian CMOs currently hold a significant portion of the market for generic and semi-custom chemical synthesis, including HDAC inhibitors akin to Vorinostat. Zhejiang Hisun Pharmaceutical and Jubilant Biosys are examples of companies with capacity for GMP quality production and process development. Their capabilities are bolstered by lower manufacturing costs and established export channels.
b. Western Manufacturers and Specialized CMOs
Large North American and European CMOs, such as Catalent and Recipharm, may produce finishing formulations but typically rely on specialized chemical synthesis firms for APIs. There is a trend towards consolidating supply chains for high-value compounds like Vorinostat, emphasizing high purity, process reproducibility, and supply security.
c. Proprietary API Suppliers
The origin of API supplies for Vorinostat in the global market remains largely undisclosed, often due to licensing arrangements. Nonetheless, companies such as ChemCon Asia and Univar Solutions supply APIs and intermediates globally. Their role is vital in maintaining supply continuity under GMP standards.
Formulation and Final Dosage Product Suppliers
For clinical and commercial phases, pharmaceutical companies or third-party manufacturers manage formulation.
a. Contract Formulation Manufacturers
Firms like Catalent, Lonza, and Baxter have extensive experience in oral solid and liquid formulations. Their manufacturing expertise ensures compliance with regulatory standards and can rapidly scale from clinical trial supplies to commercial batches.
b. In-House Development
Some biotech firms develop formulation internally during early phases. Once the molecule demonstrates efficacy, third-party manufacturers or CMOs handle scale-up, especially if proprietary patents or complex formulations are involved.
Distribution of Vorinostat: Regulatory and Logistics Considerations
Supply chain security for APIs and finished pharmaceuticals for Vorinostat remains critical. Given the molecule's developmental status, distribution often involves specialized logistics providers that maintain cold chain and ensure compliance with international regulatory standards.
Major API distributors like Sigma-Aldrich and Thermo Fisher Scientific have the capacity to supply on demand, contingent on approval and certification, to research institutions and pharmaceutical companies globally.
Emerging Trends and Future Outlook
The supply landscape for Vorinostat and similar epigenetic agents continues to evolve, driven by advances in synthesis, process optimization, and demand for affordable cancer treatments [[4]]. As patent protections expire and biosimilar and generic players enter the market, the number of suppliers will increase, potentially improving access and reducing costs.
Moreover, the ongoing debate on reliance on Chinese and Indian API producers prompts the industry to explore regional manufacturing hubs in North America and Europe to bolster supply security.
Key Takeaways
- API Manufacturing: Predominantly supplied by CMOs in Asia (China, India) with capabilities for complex chemical synthesis, but Western firms could increase roles as the market matures.
- Formulation & Final Dosage: Led by contract manufacturing organizations such as Catalent, Lonza, ensuring GMP compliance and supply scalability.
- Supply Chain Security: Critical for clinical trial and future commercial deployment; distribution relies on specialized logistics providers.
- Market Dynamics: Increasing diversification of suppliers may enhance affordability and stability, reducing dependence on a few sources.
- Regulatory Environment: Compliance with international standards remains paramount, influencing supplier selection and contract arrangements.
FAQs
1. Who are the main API suppliers for Vorinostat?
While proprietary arrangements remain confidential, key manufacturing capabilities are likely located in China, India, and other Asian countries, with some Western CMOs involved in specialized synthesis.
2. How does supplier diversification impact Vorinostat's availability?
Diversification reduces supply risks, enhances pricing competitiveness, and promotes broader access, especially as patents expire and generics emerge.
3. Can smaller biotech firms manufacture Vorinostat?
Yes, if they have access to GMP-grade synthesis capabilities and navigate regulatory requirements through partnerships or licensing agreements.
4. What are the biggest challenges in sourcing Vorinostat APIs?
Ensuring GMP compliance, securing consistent quality and supply, and managing geopolitical risks associated with supply chain concentration.
5. How might supply chain changes influence Vorinostat's market development?
Broader, more resilient, and cost-effective supply chains can accelerate clinical development and eventual commercialization, increasing patient access.
References
[1] Mazhar, M., et al. (2022). The impact of patent protections on access to medicines. Journal of Pharmaceutical Policy and Practice, 15(1), 25.
[2] Jubilant Biosys. (2023). Capabilities in custom synthesis and API manufacturing. Retrieved from https://www.jubilantbiosys.com
[3] Patheon. (2023). Contract manufacturing services for pharmaceuticals. Thermo Fisher Scientific.
[4] Smith, J., & Lee, K. (2021). Emerging trends in epigenetic drug production. Nature Reviews Drug Discovery, 20(5), 340–341.
More… ↓
