Secondary Manufacturing definition

Secondary Manufacturing means the manufacturing and packaging process used in formulating the active drug substance and all excipients into a final dosage form of a pharmaceutical product.
Secondary Manufacturing means (a) the process of producing Licensed Product for the Bayer Territory in finished form, including filling and freeze-drying of Bulk Drug Substance or (b) secondary packaging with ancillary supplies and labeling for sale to or use by an end user of Licensed Product in the Bayer Territory or (c) both.
Secondary Manufacturing means the formulation, filling, finishing and packaging of Bulk Product to create Finished Product.

Examples of Secondary Manufacturing in a sentence

  • The Secondary Manufacturing operation (formerly Plantwide Condition #9) was re-designated as (SN-23).

  • GSK shall obtain (with reasonable assistance from ALLERGAN) any necessary Marketing Authorizations from the Regulatory Authority in the Territory prior to any modifications to the API Manufacturing Facilities or Secondary Manufacturing Facilities.

  • GSK acknowledges that ALLERGAN intends to add, within the next three years, an additional production line at the Secondary Manufacturing Facility at Westport, Ireland, ("CORE 3") and an additional API Manufacturing Facility.

  • Bayer will be responsible for the Secondary Manufacturing within Section 1.2.117(b) of the Initial Licensed Products and market release in the Bayer Territory.

  • ALLERGAN shall obtain any necessary Manufacturing Authorizations from the Regulatory Authority in the country of Manufacture prior to any modifications to the API Manufacturing Facilities or Secondary Manufacturing Facilities.

  • By doing so, conclusions can be drawn about the macroscopic description of traffic flow.

  • Patheon shall store the Components at Patheon’s storage facility at the Manufacturing Site or the Secondary Manufacturing Site and shall ensure that the Components do not become subject to any lien or other security interest.

  • Patheon shall store the Active Materials at Patheon’s storage facility at the Manufacturing Site or the Secondary Manufacturing Site and shall ensure that the Active Materials do not become subject to any lien or other security interest.

  • If any restrictions limiting secondary manufacturing appear on the label, then Secondary Manufacturing should be selected.

  • Amendments to the Specifications, the Quality Agreement(s) or the Manufacturing Site or the Secondary Manufacturing Site requested by Patheon will only be implemented following the written approval of Client, which shall be in Client’s sole discretion.


More Definitions of Secondary Manufacturing

Secondary Manufacturing means the blending of the monovalent Product, e.g. [***] Monovalent, to form trivalent Product, and the filling, finishing and packaging of such trivalent Product to create Finished Product.

Related to Secondary Manufacturing

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Third Party Manufacturer means any person, firm or company which carries out the reproduction of Work and/or manufactures and/or prints the Licensed Publication on behalf of the Licensee;

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Manufacturing Process means any process for—

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Hemp products means all products made from industrial hemp,

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Cannabis products means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Marijuana-infused products means products that contain marijuana or marijuana extracts and are intended for human use. The term "marijuana-infused products" does not include useable marijuana.