ACGGP API Documentation

active pharmaceutical ingredients (APIs)

For the pharmaceutical business, A&C produces and supplies a limited range of active pharmaceutical ingredients (APIs). The active elements of a medication product are known as active pharmaceutical ingredients. Currently, a wide range of applications, including OTC, cutaneous, ophthalmic, and nasal medication formulations, use our GMP APIs.

Health Canada has granted A&C a Drug Establishment License for the production, labelling, testing, and distribution of active pharmaceutical components.

GMP-compliant active pharmaceutical components

2-Phenoxyethanol is included in the list of active pharmaceutical substances below as well. A&C has a CEP (certificate of appropriateness) to the European Pharmacopeia monograph (Ph. Eur.) for this product. Every product on the list is easily accessible and comes with the necessary supporting paperwork.

The aspect of our company with the strictest requirements for A&C’s quality and regulatory functions is represented by active pharmaceutical ingredients. Because our entire quality management system is elevated to the highest GMP standards, our involvement in the API market benefits our other lines of business, which include excipients, buffers, and process solutions. Strictest guidelines must be followed during the production, testing, packing, labeling, importation, and distribution of active pharmaceutical components.

SKU	CAS NO	NAME	DESCRIPTION	SDS	PRODUCT SPEC
P1820224	122-99-6	2-PHENOXYETHANOL MULTI-COMPENDIAL API GRADE	A&C’s 2-Phenoxyethanol API multi-compendial is an active ingredient which meets current USP-NF, EP and BP specifications. It is manufactured and distributed according to Health Canada's GMP guidance (GUI-0104) in line with ICH Q7 GMPs for APIs. It is a broad spectrum anti-microbial agent with low toxicity and has been used as a preservative in pharmaceutical applications.		PDF
A2949325	79307-93-0	AZELASTINE HYDROCHLORIDE	A&C’s Azelastine Hydrochloride meets the current USP-NF and EP specifications, if tested. It is a non-selective antihistamine and is typically used in nasal and ophthalmic dosage forms. It is formulated alone or in combination with fluticasone propionate.		PDF
B14155	8001-54-5	BENZALKONIUM CHLORIDE 50% MULTI-COMPENDIAL	A&C’s Benzalkonium Chloride (BKC) 50% is an effective biocide that meets current USP-NF and EP requirements.
P1384	217182-78-0	PHENOL LIQUEFIED 90% USP	A&C’s Phenol Liquefied 90% is an Active Pharmaceutical Ingredient (API) that conforms to the current USP-NF monograph. It is manufactured and distributed according to Health Canada's GMP guidance (GUI-0104) in line with ICH Q7 GMPs for APIs.	PDF	PDF
P13840	217182-78-0	PHENOL LIQUEFIED 90% USP STABILIZED	A&C’s Phenol Liquefied 90% is an Active Pharmaceutical Ingredient (API) stabilised with 20 ppm Citric Acid USP. It conforms to the current USP-NF monograph, and is manufactured and distributed according to Health Canada's GMP guidance (GUI-0104) in line with ICH Q7 GMPs for APIs.		PDF

Health Canada regularly audits A&C for all of the aforementioned API-related operations to ensure that we meet regulations for our APIs. Additionally, we fulfill the standards for pharmaceutical manufacture outlined in ICH Q7 and related guidelines. Our testing is validated and employs fully qualified, validated, and calibrated testing and measuring equipment in order to comply with ICH regulations. It also implies that we strictly adhere to the rules for data integrity. Our manufacturing and cleaning processes must, therefore, be thoroughly validated and kept up to date in compliance with our validation master plan. For our products, we have qualified and validated container closure mechanisms that are backed by extensive stability testing. In addition, our items are distributed and stored in accordance with GDP regulations.

We are listed as a foreign drug establishment with the FDA. Even though we are fulfilling these standards, A&C never stops developing our quality management system. This is achieved through regular regulatory audits, certification audits, self-audits, and audits from our significant foreign clients.

At A&C, we take a comprehensive approach to our quality control system. There is a connection and interdependence between the manufacturing controls, procedures, product handling, rigorous testing, continuous improvement, and verification and validation operations. Our validation report for the new product development process is one clear illustration of this. We utilize the CTD compatible format for all of our recently created items. This makes it simple for us to file an ASMF or Drug Master File (DMF) while creating APIs. When we applied for the Phenoxyethanol Multi-Compendial API grade certificate of appropriateness (CEP), we devised this strategy. The benefit of satisfying the highest requirements for all of our goods, including active pharmaceutical ingredients, excipients, buffers, and process solutions, is thus provided by our licenced actives company. Our clients may relax knowing that if it’s made by A&C, it is actively GMP.