Anuh Pharma 2016: WHO PQ suspension, EU CEP takeaways

Why Anuh Pharma’s regulatory updates matter

Anuh Pharma Ltd. has been referenced for multiple regulatory milestones that cut both ways: product approvals and subsequent suspensions tied to manufacturing-site observations. On one side, the company announced receiving a Certificate of Suitability of European Pharmacopeia (CEP) for Ambroxol Hydrochloride (HCL) for supply to the European Union market. On the other, the World Health Organization (WHO) removed two Anuh Pharma APIs from its prequalification list in April 2016 after issues flagged at its Boisar facility in Maharashtra.

These developments matter because they directly affect where and to whom an API maker can supply, especially in regulated markets and global procurement channels. The information below consolidates what was stated in the provided material, without extending beyond it.

Company profile and product basket cited

Anuh Pharma Ltd. is described as offering a range of active pharmaceutical ingredients (APIs) across multiple therapy areas. The product categories explicitly mentioned include Macrolides, Anti-TB drugs, Anti-Malarials, Anti-Bacterials, and Corticosteroids. The company is also stated to be involved in the production of Anti-Bacterials, Anti-Malarial, and Corticosteroids.

The head office is stated to be in Worli, Mumbai. The manufacturing site discussed in the regulatory actions is the Boisar facility located in Maharashtra.

Inspections and approvals mentioned across agencies

The material states that the company has successfully passed inspections from USFDA, EDQM, Eu-GMP, and WHO. It also says Anuh Pharma expanded capacity for various products and received approvals from COFEPRIS and WHO for different medications, although the specific products under those approvals are not detailed in the text.

Separately, the text also notes that the company got approval from WHO PQ Geneva authorities for Pyrazinamide and Sulfadoxine. That context is important because the later 2016 update describes these same APIs being suspended or removed from WHO’s prequalification list.

EU-market development: CEP for Ambroxol Hydrochloride

Anuh Pharma Ltd. announced that it received a Certificate of Suitability of European Pharmacopeia (CEP) for Ambroxol Hydrochloride (HCL) for supply to the European Union market. No date for this CEP announcement is provided in the supplied text, and no additional CEP identifiers are included.

The article data also references a “List of Certificates of Suitability (CEPs) for APIs issued to Anuh Pharma Ltd by EDQM” sourced from the EDQM database, with a note “Displaying: 301 - 350 of 675.” However, the table snippet shown in the material lists WHO prequalification entries for finished pharmaceutical products and applicants other than Anuh Pharma. As a result, only the Ambroxol HCL CEP claim can be treated as explicitly attributable to Anuh Pharma in the provided content.

April 2016: WHO removes pyrazinamide and sulfadoxine

Dated April 27, 2016, the material states that the WHO announced it was removing two of Anuh Pharma’s products, pyrazinamide and sulfadoxine, from its list of prequalified APIs. The decision followed a February inspection by French health officials at the company’s Boisar facility that “turned up 24 deficiencies,” as cited to FDANews in the text.

The same material says France’s health authority subsequently called for withdrawal of Anuh’s GMP certificate. WHO stated the APIs would remain off the list until the facility’s GMP compliance status was reinstated.

EDQM and EMA references linked to the same sequence

The text further describes the WHO action as coming after EDQM suspended the certificate of suitability for three products “last month” following an inspection of the Boisar site. The three products are not named in the provided excerpt.

Anuh Pharma’s notice to the Bombay Stock Exchange (BSE) is described as stating that the WHO action followed a ban by the European Medicines Agency (EMA) on shipping antibiotic APIs from the Boisar plant pending an inspection. The company’s filing, as reproduced in the text, links these steps by stating that in view of the EDQM suspension, WHO prequalification authorities suspended pyrazinamide and sulfadoxine until a WHO-led inspection.

What WHO prequalification means in this context

The material explains prequalification as a process under which drug companies must fulfil WHO-stipulated conditions to become eligible to supply vaccines to UN procurement agencies globally. While the text uses vaccines in its definition, the same passage is used to explain the significance of prequalification status in general.

In the Anuh Pharma case described, the practical outcome was that the two APIs, pyrazinamide and sulfadoxine, were suspended or removed from the WHO list until GMP compliance status was reinstated.

Market reaction reported on the day

The text includes a specific stock market datapoint: shares of Anuh Pharma were trading at Rs 172.20 on BSE, down 2.10% from the previous close, in the context of reporting the WHO suspension.

No other price or volume details, time stamps, or follow-up price moves are provided.

Requested bulk prices: Acepifylline and Amodiaquine

The provided material does not state any selling price, quotation range, tender rate, or contract rate for Acepifylline bulk offered by Anuh Pharma. It also does not state any selling price, quotation range, tender rate, or contract rate for Amodiaquine bulk offered by Anuh Pharma.

Based strictly on the supplied text, the prices for Acepifylline bulk and Amodiaquine bulk offered by Anuh Pharma are not available.

Key facts snapshot

Conclusion

The supplied information presents a mixed regulatory picture for Anuh Pharma: an EU-facing CEP for Ambroxol Hydrochloride (HCL) alongside the April 2016 WHO prequalification suspension/removal of pyrazinamide and sulfadoxine linked to Boisar-site deficiencies and subsequent actions involving EDQM, EMA, and French health authorities. The company’s own filing, as quoted, ties WHO’s step to the EDQM suspension and a pending WHO-led inspection.

Any update on reinstatement of GMP compliance status, restoration of WHO prequalification, or the pricing of Acepifylline and Amodiaquine bulk would require additional, explicitly stated disclosures beyond the provided material.