Anuh Pharma: Key WHO PQ, CEP Events Since 2015

What the source material covers

The provided text references an overview-style dataset touching on product quality approvals, regulatory actions, and capacity expansion related to Anuh Pharma Ltd. It cites WHO prequalification (WHO PQ) outcomes for certain APIs, EDQM actions around Certificates of Suitability (CEPs), and a company expansion that added manufacturing capacity. It also includes reporting dated April 27, 2016, describing WHO removing Anuh APIs from the prequalification list following inspection findings at the Boisar facility in Maharashtra.

The same source set also contains later milestones including the commissioning of an expansion project in December 2019 and mention of Ambroxol Hydrochloride receiving CEP from EDQM in 2022, along with a separate line stating the company received USFDA and CEP for Ambroxol Hydrochloride during 2019-2020. Since these statements are presented without supporting primary documents in the provided text, the article below reports them as described, without adding additional assumptions.

WHO PQ approvals mentioned in the text

The text states that in 2015 the company received approval of WHO PQ for Sulfadoxine. It also says the company has got approval from WHO PQ Geneva authorities for Pyrazinamide and Sulfadoxine. Separately, a small table fragment titled as “List of Certificates of Suitability (CEPs) for APIs issued to Anuh Pharma Ltd by EDQM” includes an entry “Pyrazinamide Ph. Eur.” with “WHO - PQ” and “WHOAPI - 158,” indicating an association with WHO PQ in the original dataset.

Taken together, the source material indicates Anuh Pharma’s APIs Pyrazinamide and Sulfadoxine were connected to the WHO prequalification system, with approvals noted at some points in time. But the same material also documents a later suspension and removal from the prequalified list, which materially changes how investors interpret the continuity of such approvals.

WHO removal and suspension event (April 2016)

A report dated April 27, 2016, states that WHO announced it was removing two of Anuh Pharma’s products, pyrazinamide and sulfadoxine, from its list of prequalified APIs. The trigger cited was a February inspection by French health officials of the Boisar facility that reportedly found 24 deficiencies, according to FDANews as referenced in the text.

The same report says France’s health authority called for withdrawal of Anuh’s GMP certificate. WHO, as described, said the APIs would remain off its list until the facility’s GMP compliance status had been reinstated. The text further describes this as the second such action against Anuh’s Boisar facility.

Linkage to EDQM and the EMA, as described

The source material states that the WHO suspension followed a ban by the European Medicines Agency (EMA) for shipping antibiotic APIs from the Boisar plant, pending an inspection. It also says the WHO action occurred “in view of the EDQM suspension,” and that WHO prequalification authorities suspended pyrazinamide and sulfadoxine “until the WHO led inspection,” as quoted in a notice referenced as being filed to the Bombay Stock Exchange.

In another portion, the text states EDQM had suspended certificates of suitability for three products “last month” after conducting an inspection of the manufacturing site at Boisar. The provided excerpts do not list the three products in that line, and no dates are given for that “last month” reference beyond the context of the April 2016 reporting.

Capacity expansion and commissioning timeline (2019)

The text states that in March 2019, the company opened a new expansion with additional capacity of 900 MTPA for 20 different products. It also states the company commissioned the new expansion project by starting commercial production in December 2019.

This is the clearest operational data point in the provided material because it includes a capacity number (900 MTPA), a month and year for the expansion opening (March 2019), and a month and year for commercial production start (December 2019). No revenue, capex amount, or utilization numbers are provided.

Ambroxol Hydrochloride: CEP and other regulatory mentions

The source material says Anuh Pharma received CEP for Ambroxol Hydrochloride from EDQM in 2022. Separately, it also states: “The company has received USFDA and CEP for Ambroxol Hydrochloride during 2019-2020.” The excerpts do not reconcile these two timelines or specify whether one refers to different filings, renewals, or other regulatory actions.

The text also includes a stand-alone line that Anuh Pharma Ltd. announced it has received a Certificate of Suitability of European Pharmacopeia (CEP) for Ambroxol Hydrochloride (HCL) for supply to the European Union market. No date is attached to this sentence in the provided excerpts.

Request check: price of Amodiaquine bulk offered

The prompt asks to “Find a price of Amodiaquine bulk offered by Anuh Pharma.” The provided source text does not include any price, quotation, tender rate, invoice, or catalogue reference for Amodiaquine bulk. It also does not confirm that Anuh Pharma offers Amodiaquine bulk in the referenced dataset.

Based strictly on the provided material, no verifiable price can be extracted or reported. Any price would require an external source such as a supplier quotation, export-import shipment records, or a company product and pricing list, none of which are present in the text.

Key facts table from the provided text

Market relevance for investors tracking API regulatory risk

From a stock market perspective, the provided excerpts highlight two core themes that matter for API manufacturers: regulatory compliance and market access. The April 2016 WHO removal and the references to EDQM and EMA actions are compliance-driven events that can affect eligibility to supply regulated markets and international procurement-linked channels.

On the operational side, the expansion details in 2019 show a capacity addition of 900 MTPA across 20 products and a defined commercial start date in December 2019. While the text does not provide financial outcomes, capacity additions are typically tracked by investors as a precursor to volume growth, product diversification, and potential customer onboarding, subject to quality approvals and sustained compliance.

Conclusion

The source material presents a mixed timeline for Anuh Pharma, with WHO PQ-related approvals mentioned for Sulfadoxine and references to WHO PQ for Pyrazinamide, alongside a documented April 2016 removal from WHO’s prequalification list tied to inspection findings at Boisar. It also records a 900 MTPA expansion opened in March 2019 and commercially commissioned in December 2019, plus later mentions of Ambroxol Hydrochloride CEP from EDQM.

Any claim about Amodiaquine bulk pricing cannot be supported from the provided text, because no price data is included. The next concrete information point, based on the excerpted items, would be any dated regulatory filing or updated inspection outcome that clarifies reinstatement status and the current standing of the cited approvals.